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Linvatec Corp.

United StatesFDA applicant, unverified

Devices
93
FDA recalls
56

What Linvatec Corp. makes

Linvatec Corp. manufactures surgical instruments and systems for minimally invasive procedures, including ablation devices like the Trident Resection Ablator and LightWave Suction Ablators (models EL-2000-S, IA-2000-S, and IA-), as well as tissue morcellation tools such as the CUTO system. The company also produces endoscopic and hysteroscopic devices, including the EndoPearl and EndoPearl with Threader, continuous flow hysteroresectoscopes, and universal drive and irrigation systems. Suturing solutions like the Super Revo Herculine Suture Anchor Washer are part of its portfolio, alongside xenon light sources for surgical illumination.

Linvatec Corp.’s devices are classified under FDA regulations as Class I and Class II, with most requiring 510(k) clearance. The company’s products are listed in the FDA’s 510(k) registry, reflecting their authorised status under U.S. medical device regulations. The manufacturer operates from the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue93

Newest first, rows 51-93 of 93

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  • Super Revo Suture Anchor Ref K003984

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Linvatec Powerlink Surgical Shaving System Ref K934379

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cannuloc Threaded Cannula Ref K955273

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Electrodes Ref K944992

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Biobutton Ref K990194

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Concept Cannulated Intereference Screw Ref K933352

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Integrated Drive/Pump System For Otolaryngology Ref K981637

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Powerpro Battery System Ref K012320

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Bioscrew Xtralok, 8x35mm & 8x40mm Violet Ref K050497

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Preloaded Soft Tissue Anchor Ref K953954

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ultrablator Electrode Ref K030720

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Resection Ablator Ref K013117

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Meniscal Repair Device Ref K981692

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Verres Needle Ref K942484

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • 3-Ccd Digital Camera System Ref K031098

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Biorc Anchor Ref K990770

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Pressure Sensing Scope Sheath System Ref K944553

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Intraarc Drive System Ref K951263

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Micropower Hand Piece: Oral Max High Speed Drill Ref K060270

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Trocar Sleeve, Sealing Caps, Reducer, Loop Guide Ref K942414

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Advantage Drive System Ref K002523

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hem-O-Lok -- Modification Ref K922186

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Advanced Turbo Drive System Ref K050519

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Bioanchor With Disposable Driver Ref K033804

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Poly Blades Ref K940515

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hall Modular Acetabular Reamer System Ref K960852

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Apex Universal Drive System Ref K944476

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Conmed Linvatec Intercept Implant Ref K092998

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Apex Universal Drive System Ref K964548

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ultrablator Electrode Ref K993885

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Inteq Tfcc Repair System Ref K941862

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Bio-Anchor Ref K955486

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Bioscrew Absorbable Interference Srew Ref K973758

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Irrigation System Ref K961192

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Integrated Drive/Pump System Ref K981636

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Bioanchor With Disposable Driver, Preloaded With One #2 Herculine Suture Ref K042778

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Interference Screw Ref K960962

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • E9000 System Ref K990524

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Pre-Loaded Ultrafix Rc Ref K013553

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sensatec Endoscopic Instruments Ref K942080

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Conmed Linvatec Paladin, Preloaded With Two #2 Hi-Fi Sutures Ref K090186

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Universal Drive System Ref K971059

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Shaver Ablator Ref K002088

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 51-93 of 93

Showing 51-93 of 93

FDA recalls56

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 56 recalls initiated by Linvatec Corp., the earliest on 2004-08-26 and the most recent on 2008-02-21. By recorded status: 56 terminated. The reasons filed fall into these groups: sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Showing the 10 most recent of 56 recalls.

  • 2008

    • 21 Feb 2008 Z-0360-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices. Distribution: Worldwide Distribution
    • 21 Feb 2008 Z-0361-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices. Distribution: Worldwide Distribution
    • 21 Feb 2008 Z-0362-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices. Distribution: Worldwide Distribution
    • 21 Feb 2008 Z-0363-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices. Distribution: Worldwide Distribution
    • 21 Feb 2008 Z-0364-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices. Distribution: Worldwide Distribution
    • 21 Feb 2008 Z-0365-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices. Distribution: Worldwide Distribution
    • 21 Feb 2008 Z-0366-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices. Distribution: Worldwide Distribution
    • 21 Feb 2008 Z-0367-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices. Distribution: Worldwide Distribution
    • 21 Feb 2008 Z-0368-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices. Distribution: Worldwide Distribution
    • 21 Feb 2008 Z-0369-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices. Distribution: Worldwide Distribution
Show the 25 most recent of 56 recalls

  • 2008

    • 21 Feb 2008 Z-0370-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices. Distribution: Worldwide Distribution
    • 21 Feb 2008 Z-0371-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices. Distribution: Worldwide Distribution
    • 21 Feb 2008 Z-0372-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices. Distribution: Worldwide Distribution
    • 21 Feb 2008 Z-0373-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices. Distribution: Worldwide Distribution
    • 21 Feb 2008 Z-0374-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices. Distribution: Worldwide Distribution
    • 21 Feb 2008 Z-0375-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices. Distribution: Worldwide Distribution
    • 21 Feb 2008 Z-0376-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices. Distribution: Worldwide Distribution
    • 21 Feb 2008 Z-0377-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices. Distribution: Worldwide Distribution
    • 21 Feb 2008 Z-0378-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices. Distribution: Worldwide Distribution
    • 21 Feb 2008 Z-0379-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices. Distribution: Worldwide Distribution
    • 21 Feb 2008 Z-0380-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices. Distribution: Worldwide Distribution
    • 21 Feb 2008 Z-0381-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices. Distribution: Worldwide Distribution
    • 21 Feb 2008 Z-0382-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices. Distribution: Worldwide Distribution
    • 21 Feb 2008 Z-0383-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices. Distribution: Worldwide Distribution
    • 21 Feb 2008 Z-0384-2009 Unclassified (pre-2012) Terminated Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices. Distribution: Worldwide Distribution