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Stryker Instruments

United States·US-MF-000025219

Last updated September 17, 2026

Information

Country
United States
Address
1941, Stryker Way, Portage, United States
Website
www.stryker.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
+1 8002533210
PRRC Contact
Caitlyn Covault
EUDAMED SRN
US-MF-000025219
FDA FEI Number
3015967359
DUNS Number
—

Catalogue (93)

Page 2 of 2
DeviceModel / ReferenceRegistriesClassStatus
POWEReam 1/4 Drive K233300
FDA 510(k)
Class IIActive
Bonesource Hac K021440
FDA 510(k)
Class IIActive
Universal Cmf System K022185
FDA 510(k)
Class IIActive
Consolidated Operating Room Equipment (CORE) 2 Console K243958
FDA 510(k)
Class IIActive
Universal Neuro System K031659
FDA 510(k)
Class IIActive
Stryker Rf Coaxial Bipolar Electrodes & Cannulae K043442
FDA 510(k)
Class IIActive
Dekompressor Percutaneous Discectomy Probe K032473
FDA 510(k)
Class IIActive
Stryker Steri-Shield 8 Surgical Hoods and Togas K241272
FDA 510(k)
Class IIActive
Stryker Leibinger Cranial Fixation System K030378
FDA 510(k)
Class IIActive
Stryker Mmf Screw K050535
FDA 510(k)
Class IIActive
Stryker Painpump Pca K003543
FDA 510(k)
Class IIActive
Radiosystem/Nt, Model 80-13020 K020320
FDA 510(k)
Class IIActive
PhotonBlade 3; PhotonBlade 3 Smoke Evacuation K250483
FDA 510(k)
Class IIActive
Stryker T6 Hoods And Togas K063005
FDA 510(k)
Class IIActive
Stryker T4 Power Pack, Stryker T4 Eight Station Battery Charger, Stryker T4 Charger Module K994053
FDA 510(k)
Class IIActive
OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit) K250213
FDA 510(k)
Class IIActive
Stryker Leibinger Resorbable Fixation System K993061
FDA 510(k)
Class IIActive
Bone Source Hac Rapid Setting Cement K043334
FDA 510(k)
Class IIActive
Bonesource Hac Fast Setting Cement K032366
FDA 510(k)
Class IIActive
Stryker Precision Dental Implant System K921805
FDA 510(k)
Class IIActive
Stryker Knifelight, Stryker Illuminated Retractor K981717
FDA 510(k)
Class IIActive
Stryker Remote Surgical Planning System K004027
FDA 510(k)
Class IIActive
Stryker Antimic Catheter K072702
FDA 510(k)
Class IIActive
Stryker T4 Hytrel Toga K070078
FDA 510(k)
Class IIActive
Stryker Aria Pneumatic System K061725
FDA 510(k)
Class IIActive
Stryker Discmonitor K050753
FDA 510(k)
Class IIActive
Leibinger Neuro Clip System K003660
FDA 510(k)
Class IIActive
Stryker Rf Parallel Bipolar Adaptor Cable K061660
EUDAMEDFDA 510(k)FDA UDI
Class IIActive
Ivas 2-10mm (10 Gauge) Balloon Catheter, Ivas 2-15 Mm(10 Gauge)0705-115-500, Ivas 3-10mm(8 Gauge)balloon Catheter, Ivas K093419
FDA 510(k)
Class IIActive
Stryker Rf Electrodes And Cannulae K032406
FDA 510(k)
Class IIActive
Newgen/Universal Mandibular System K014263
FDA 510(k)
Class IIActive
Stryker Venom Electrodes And Cannulae K123178
FDA 510(k)
Class IIActive
Stryker Constavac Blood Conservation System Ii (cbcii) K970714
FDA 510(k)
Class IIActive
Stryker Knifelight K961122
FDA 510(k)
Class IIActive
Painpump2 K043466
FDA 510(k)
Class IIActive
RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer K251971
FDA 510(k)
Class IIActive
Stryker Constavac Blood Conservation System Ii (cbcii) K952224
FDA 510(k)
Class IIActive
POWEReam Xia/Serrato K240526
FDA 510(k)
Class IIActive
Stryker Hermes-Ready Total Performance System K991696
FDA 510(k)
Class IIActive
Leibinger Quik Disk Titanium Clamp System K993990
FDA 510(k)
Class IIActive
Transport Carts 6700-313-700
EUDAMEDFDA UDI
Class IActive
Neptune 0702-310-000
EUDAMEDFDA UDI
Class IActive
Sonopet 5450-850-410
EUDAMEDFDA UDI
Class IActive

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Authorities

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FDA Recalls (6)

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
Jun 24, 2022Z-1478-2022—open, classified

There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the potential for surgical intervention or damage to critical neurological or vascular structures.

Jul 14, 2004Z-0020-05—terminated

The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affected the patient tracker system.

Jul 14, 2004Z-0021-05—terminated

The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affected the patient tracker system.

Nov 12, 2003Z-0171-04—terminated

Product sterility may have been compromised by an inadequate package seal.

Jun 1, 2003Z-0921-03—terminated

Non-sterilized product sold as sterile.

Dec 3, 2002Z-0524-03—terminated

Cap may be cracked and fail, exposing O.R. staff to patient blood, and cause an unexpected loud noise in the O.R.