Arca
Skip to content

Stryker

Medical device maker in United States. FDA records under 10 spellings of its name, each linked to the record.

  • Group records: 4,743, 72 entities
  • 510(k) clearances: 3,084
  • Device recalls: 1,583
  • Drug recalls: 70
  • AI-enabled devices: 3

Records by Year

Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Stryker and its 71 subsidiaries

Latest Records

Newest first across sources; each opens the record
DateRecordSource
Oct 28, 2026Tornier Humeral Reconstruction System (HRS) Tuberosity BodyK263583 · KWS510(k) clearances
Oct 20, 2026SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch (0795-007-000)K262386 · GEI510(k) clearances
Oct 9, 2026Excelsior Reach MicrocatheterK261649 · QJP510(k) clearances
Oct 8, 2026Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000); Sonopet iQ+ 10mm iQ+ Blade (5500-26B-010); Sonopet iQ+ 20mm iQ+ Blade (5500-26B-020); Sonopet iQ+ 11cm iQ+ Apex Knife (5500-26B-114); Sonopet iQ+ 12cm iQ+ Apex 360 (5500-26B-312); Sonopet iQ+ 12cm iQ+ Claw (5500-26B-328)K262244 · LFL510(k) clearances
Sep 18, 2026Triever Duo CatheterK253419 · QEW510(k) clearances
Sep 17, 2026Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)K261959 · GEI510(k) clearances
Aug 21, 2026Artix™ MT;Artix™ Thin-Walled SheathK262538 · QEW510(k) clearances
Aug 18, 20262% Chlorhexidine Gluconate* Cloth, Non-sterile, 6 Disposable cloths, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013. NDC: 53Class II · Cross Contamination with Other ProductsDrug recalls
Jul 30, 2026AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownK262369 · MBI510(k) clearances
Mar 16, 2026SurgiCount+ SystemK252282 · General HospitalAI-enabled devices
Jan 11, 2024SurgiCount+ SystemK232250 · General HospitalAI-enabled devices
Sep 29, 2023HipCheckK230045 · RadiologyAI-enabled devices
Jun 27, 2017NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH2000 (single drape), Sterile, Rx. Manufactured for: Novadaq Technologies Inc., Class II · The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrierDevice recalls
Jun 27, 2017NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (Product Code HH9001),Class II · The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrierDevice recalls
Jun 27, 2017NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH 2020 (box of 20 HH2000 drapes), Sterile, Rx.. Manufactured for: Novadaq TechnologClass II · The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrierDevice recalls
Apr 6, 2017Warning letter: 510(k) requiredCDRHWarning letters
Aug 18, 2016Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) The SPY Fluorescent Imaging System is intClass II · Novadaq is informing SK6000 PAQ users that a pinhole through the drape pouch film material was identified in some SK6000Device recalls

Subsidiaries and Divisions

The 60 with the most records, of 71 subsidiaries in the Stryker group, which counts 72 entities with Stryker itself

Canada and Imports

Across the Stryker group, matched by company name
Active Health Canada device licences
883, as of Nov 10, 2026
FDA import refusals since 2024
7 shipment lines, through Oct 23, 2026

Names and Identifiers

Appears as
Stryker Corp.Stryker CorporationStrykerStryker GmbHStryker Corporation (Tornier, Inc.)Stryker Corporation (Tornier, S.A.S.)Stryker, Inc.

Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.