Stryker

FDA Filings

This page includes the latest FDA filings for Stryker. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Stryker
Trevo NXT ProVue Retriever2019-11-22
Stryker
Trevo Trak 21 Microcatheter2019-11-22
Stryker GmbH
Variax Foot2019-11-22
Stryker Orthopaedics
EXETER Centralizer, EXETER 2.5mm Plug2019-08-28
Stryker GmbH
VariAx 2 System, VariAx 2 Mini Fragment System2019-08-23
Stryker Orthopaedics (aka Howmedica Osteonics Corp.)
Triathlon Total Knee System-Additional Components2019-08-22
Stryker Leibinger GmbH & Co. KG
Stryker CMF MEDPOR Priority Customized Implant Kit2019-08-15
Stryker Neurovascular
AXS Vecta Aspiration System2019-07-30
STRYKER SPINE
Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage2019-07-25
Stryker Corp.
Stryker CrossFlow Integrated Arthroscopy Pump2019-07-12
Stryker
Stryker PEEK Customized Cranial Implant Kit2019-07-11
Stryker
Stryker Surgeon ID Mandible Recon Plate2019-06-28
Stryker
Trevo XP ProVue Retriever2019-06-25
Stryker Corporation
Stryker MIS And Footed Attachments2019-06-18
Stryker
Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments2019-06-14
Stryker Trauma Gmbh
T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System2019-06-11
Stryker GmbH
Mini Cannulated Headed And Headless Screw Set2019-06-10
Stryker
L10 LED Light Source With AIM, L11 LED Light Source With AIM2019-05-10
Stryker Sustainability Solutions
Reprocessed ViewFlex Xtra ICE Catheter2019-05-08
Stryker
Synchro2 Support Guidewire2019-05-01
Stryker Neurovascular
AXS Vecta Aspiration System2019-04-24
Stryker Corporation
Sonopet IQ Ultrasonic Aspirator System2019-04-11
Stryker
AXS Catalyst 7 Distal Access Catheter (068 X 115cm, 068 X 125cm, 068 X 132cm)2019-03-13
Stryker
AXS Catalyst Distal Access Catheter 068 X 115cm, AXS Catalyst Distal Access Catheter 068 X 125cm, AXS Catalyst Distal Access Catheter 068 X 132cm2019-03-13
Stryker
Stryker SternalPlate System2019-03-05
Stryker GmbH
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)2019-02-15
Stryker Corporation
Stryker Navigation System With SpineMap Go Software Application, Fluoroscopy Trackers And Fluoroscopy Adapters, SpineMask Tracker2019-02-14
Stryker Corporation
Stryker IVAS Elite Inflatable Vertebral Augmentation System (Stryker IVAS Elite Balloon Catheter)2018-12-21
Stryker Corp.
HipCheck2018-12-13
Stryker Leibinger GmbH & Co. KG
Universal Mesh - Sterile2018-11-06

Latest Premarket Applications

PMAManufacturerDevice NameDate
STRYKER CORPORATION
S.T.A.R Ankle System2019-10-21
Stryker Neurovascular
Neuroform Atlas® Stent System2019-05-16
Stryker Neurovascular
Surpass Streamline Flow Diverter2018-11-14
Stryker Neurovascular
Surpass Streamline Flow Diverter2018-10-05
Stryker Neurovascular
Surpass Streamline Flow Diverter2018-07-13
STRYKER CORPORATION
S.T.A.R. Ankle System2018-01-08
STRYKER CORPORATION
SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R. ANKLE)2016-09-28
STRYKER CORPORATION
SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE)2016-09-01
STRYKER CORP.
VITAGEL RT3 SURGICAL HEMOSTAT2015-07-16
STRYKER CORP.
VITAGEL SURGICAL HEMOSTAT (RT3)2015-04-14
STRYKER CORP.
VITAGEL SURGICAL HEMOSTAT (RT3)2015-04-13
STRYKER CORP.
VITAGEL RT3 SURGICAL HEMOSTAT2014-12-12
STRYKER CORP.
VITAGEL RT3 DELIVERY SYSTEM2014-06-05
STRYKER CORPORATION
SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM STAR ANKLE2014-06-04
STRYKER CORPORATION
SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (STAR ANKLE)2014-05-09
STRYKER CORP.
VITAGEL SURGICAL HEMOSTAT (VITAGEL)2014-02-11
STRYKER CORP.
RT3 SURGICAL HEMOSTAT2014-01-27
STRYKER CORP.
VITAGEL RT3 SURGICAL HEMOSTAT2013-11-15
STRYKER CORPORATION
SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (STAR ANKLE)2013-05-01
STRYKER CORPORATION
SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (STAR ANKLE)2013-01-24
STRYKER CORP.
VITAGEL SURGICAL HEMOSTAT2012-10-04
STRYKER CORP.
CELLPAKER PLASMA COLLECTION DEVICE2012-01-31
STRYKER CORP.
VITAGEL SURGICAL HEMOSTAT2011-02-25
STRYKER CORP.
VITAGEL SURGICAL HEMOSTAT2011-02-04
STRYKER CORPORATION
SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM2010-12-27
STRYKER CORP.
VITAGEL SURGICAL HEMOSTAT2010-12-02
STRYKER CORPORATION
SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM2010-10-08
STRYKER CORP.
VITAGEL SURGICAL HEMOSTAT2010-07-23
STRYKER CORP.
ORTHOVITA'S VITAGEL SURGICAL HEMOSTAT2010-04-02
STRYKER CORP.
VITAGEL SURGICAL HEMOSTAT2009-10-23

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
NA
STRYKER CORPORATION2019-11-27
NA
STRYKER CORPORATION2019-11-27
Stryker
STRYKER CORPORATION2019-11-26
TRIO TRAUMA
Stryker Corporation2019-11-26
TRIO TRAUMA
Stryker Corporation2019-11-26
ES2 SPINAL SYSTEM
Stryker Corporation2019-11-26
NAVIGATED XIA 3
Stryker Corporation2019-11-26
NAVIGATED XIA 3
Stryker Corporation2019-11-26
NAVIGATED XIA 3
Stryker Corporation2019-11-26
NAVIGATED XIA 3
Stryker Corporation2019-11-26
NAVIGATED XIA 3
Stryker Corporation2019-11-26
NAVIGATED XIA 3
Stryker Corporation2019-11-26
NAVIGATED XIA 3
Stryker Corporation2019-11-26
NAVIGATED MANTIS
Stryker Corporation2019-11-26
NAVIGATED MANTIS
Stryker Corporation2019-11-26
NAVIGATED MANTIS
Stryker Corporation2019-11-26
NAVIGATED MANTIS
Stryker Corporation2019-11-26
NAVIGATED MANTIS
Stryker Corporation2019-11-26
NAVIGATED MANTIS
Stryker Corporation2019-11-26
THOR Anterior Plating System
Stryker Corporation2019-11-26
THOR Anterior Plating System
Stryker Corporation2019-11-26
XIA ANTERIOR
Stryker Corporation2019-11-26
MANTIS Redux
Stryker Corporation2019-11-26
MANTIS Redux
Stryker Corporation2019-11-26
MANTIS Redux
Stryker Corporation2019-11-26
MANTIS Redux
Stryker Corporation2019-11-26
MANTIS Redux
Stryker Corporation2019-11-26
MANTIS Redux
Stryker Corporation2019-11-26
MANTIS Redux
Stryker Corporation2019-11-26
RELIANCE
Stryker Corporation2019-11-26
RELIANCE
Stryker Corporation2019-11-26
RELIANCE
Stryker Corporation2019-11-26
RELIANCE
Stryker Corporation2019-11-26
RELIANCE
Stryker Corporation2019-11-26
RELIANCE
Stryker Corporation2019-11-26
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