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Cp Medical

US

Last updated May 23, 2026

Information

Country
US
Address
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Website
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EUDAMED SRN
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DUNS Number
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Catalogue (435)

Page 9 of 9
DeviceModel / ReferenceRegistriesClassStatus
Polybond CP1072A
FDA UDI
Class IIActive
Polypro 8880P
FDA UDI
Class IIActive
Polypro 8629P
FDA UDI
Class IIActive
Mono-Swift K030786
FDA 510(k)
Class IIActive
Oscera7 Synthetic Absorbable Bone Wax, Model Os31 K060987
FDA 510(k)
UActive
Stainless Steel Surgical Suture, Non-Absorbable K030351
FDA 510(k)
Class IIActive
Synthetic Absorbable Seeding Spacers Made Of Polydioxanone Material K021311
FDA 510(k)
Class IIActive
Dtf-1000ll, Dtf-1000 K911118
FDA 510(k)
Class IActive
Cannula Clamp K853538
FDA 510(k)
Class IActive
Visorb Swift K023710
FDA 510(k)
Class IIActive
Modification To Accu-Space Plain Gut Absorbable Seeding Spacers K013964
FDA 510(k)
Class IIActive
Nylon, Nonabsorbable Surgical Sutures Usp K001173
FDA 510(k)
Class IIActive
Accu-Space Absorbable Seeding Spacers K010621
FDA 510(k)
Class IIActive
Orthofiber K041894
FDA 510(k)
Class IIActive
Injection Cap K913337
FDA 510(k)
Class IIActive
Monoswift K072229
FDA 510(k)FDA UDI
Class IIActive
Pre-Waxed Needles With Gold Fiduciary Markers K071550
FDA 510(k)
Class IIActive
Cp Sleeve And River Sleeve K034062
FDA 510(k)
Class IIActive
Polyester Nonabsorbable Surgical Sutures Urp K001172
FDA 510(k)
Class IIActive
Cp Medical Bone Wax K024372
FDA 510(k)
UActive
Cp-Fiber (orthofiber) K094028
FDA 510(k)
Class IIActive
Mono-Dox, Synthetic Absorbable Polydioxanone Surgical Suture, Sterile K013274
FDA 510(k)
Class IIActive
Plain And Chromic Gut Absorbable Surgical Sutures Usp K001299
FDA 510(k)
Class IIActive
Velcro Fistula Pressure Clamps K853536
FDA 510(k)
Class IIActive
Velcro Tourniquet K853537
FDA 510(k)
Class IActive
Transducer Filter K821268
FDA 510(k)
Class IIActive
Polyglycolic Acid (pga), Absorbable Surgical Suture (usp) K002190
FDA 510(k)
Class IIActive
C-PTFETM Surgical Suture K173922
FDA 510(k)
Class IIActive
Disposable Temporary Pacing Cable, Models Cpw-Bv-5, Cpw-Lg-5, Cpw-Sm-5, Cpw-Era300-5, Cpw-Qloc-5 K022075
FDA 510(k)
Class IIActive
Polypropylene, Nonabsorbable Surgical Sutures Usp K001185
FDA 510(k)
Class IIActive
Rs-1000 K911230
FDA 510(k)
Class IIActive
Dialysis Admin. Set - I.v. K840654
FDA 510(k)
Class IIActive
Silk, Nonabsorbable, Surgical Sutures, Usp K001184
FDA 510(k)
Class IIActive
Plastelast And/Or Elastoplaste K854006
FDA 510(k)
Class IActive
Cp-Sleeve K013975
FDA 510(k)
Class IIActive

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FDA Recalls (12)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Oct 18, 2019Z-0655-2020—open, classified

Failed to meet USP minimum average value for knot pull (tensile) strength.

Feb 4, 2019Z-1027-2019—open, classified

Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.

Feb 2, 2017Z-1872-2017—open, classified

The tensile strength minimum as directed by USP <881> was not met over the length of the product's shelf life.

Sep 22, 2014Z-0140-2015—terminated

CP Medical Inc. is recalling five lots of Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture for failing to meet the minimum tensile strength as dictated by USP was not met over the length of the product's shelf life.

Apr 23, 2014Z-1708-2014—terminated

CP Medical, Inc., is recalling one lot of Monoswift PGCL [poly (glycolide-co-caprolactone)] Absorbable Sutures for failing to meet the USP minimum average value for knot pull (tensile) strength.

Jun 29, 2011Z-3177-2011—terminated

Unapproved dye was used in manufacturing the non-absorbable blue nylon suture material.

Jan 2, 2009Z-0260-2012—terminated

The seal integrity of the outer product pouch may be compromised due to partial delamination of the two layers that make up part of the pouch.

Jan 2, 2009Z-0259-2012—terminated

The seal integrity of the outer product pouch may be compromised due to partial delamination of the two layers that make up part of the pouch.

Sep 17, 2008Z-2582-2010—terminated

Seal integrity of inner foil pouch of the Mono-Dox Synthetic Absorbable Suture may be compromised.

Apr 3, 2007Z-0809-2007—terminated

Potential for sterility of product to be compromised. Suture package seals incomplete or missing.

Apr 3, 2007Z-0808-2007—terminated

Potential for sterility of product to be compromised. Suture package seals incomplete or missing.

Apr 3, 2007Z-0807-2007—terminated

Potential for sterility of product to be compromised. Suture package seals incomplete or missing.