Stryker Medical

FDA Filings

This page includes the latest FDA filings for Stryker Medical. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Stryker Medical holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• THE SURGICAL COMPANY INTERNATIONAL BV
• Stryker Medical London

FDA Registration(s)

• Registration Number: 1831750
• FEI Number: 1831750
• Name: STRYKER MEDICAL
• Owner & Operator: STRYKER CORP.
• Contact Address: 1901 Romence Pkwy ; Portage MI 49002 US
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 3800 E. CENTRE AVE. ; Portage, MI 49002 US
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
OSI STRYKER MEDICAL [STRYKER CORP.]	MV3 Bariatric Bed, Patient Helper (Accessory), IV Pole (Accessory)	2019-07-09
PMN K180834 | FLL STRYKER MEDICAL [STRYKER CORP.]	Altrix Precision Temperature Management System	2018-08-13
PMN K180834 | FLL STRYKER MEDICAL [STRYKER CORP.]	Altrix Precision Temperature Management System Reusable Adapter Cable; Reusable Patient Temperature Output Cable	2018-08-13
PMN K180834 | FLL STRYKER MEDICAL [STRYKER CORP.]	Altrix Precision Temperature Management System Insulated Clik-Tite Hose; Insulated Colder Connector Hose	2018-08-13
PMN K180834 | DWJ STRYKER MEDICAL [STRYKER CORP.]	Altrix Precision Temperature Management System	2018-08-13
PMN K180834 | DWJ STRYKER MEDICAL [STRYKER CORP.]	Altrix Precision Temperature Management System Reusable Adapter Cable; Reusable Patient Temperature Output Cable	2018-08-13
PMN K180834 | DWJ STRYKER MEDICAL [STRYKER CORP.]	Altrix Precision Temperature Management System Insulated Clik-Tite Hose; Insulated Colder Connector Hose	2018-08-13
PMN K180834 Stryker Medical	Altrix Precision Temperature Management System	2018-08-10
PMN K171149 | DWJ STRYKER MEDICAL [STRYKER CORP.]	Altrix Temperature Management Wrap	2018-05-01
PMN K171149 Stryker Medical	Altrix Temperature Management Wraps	2017-07-18
PMN K152266 STRYKER MEDICAL	Altrix Precision Temperature Management System	2016-12-02
PMN K152266 | FLL STRYKER MEDICAL [STRYKER CORP.]	Altrix Precision Temperature Management System	2016-12-02
PMN K152266 | FLL STRYKER MEDICAL [STRYKER CORP.]	Altrix Precision Temperature Management System Reusable Adapter Cable; Reusable Patient Temperature Output Cable	2016-12-02
PMN K152266 | FLL STRYKER MEDICAL [STRYKER CORP.]	Altrix Precision Temperature Management System Insulated Clik-Tite Hose; Insulated Colder Connector Hose	2016-12-02
PMN K152266 | DWJ STRYKER MEDICAL [STRYKER CORP.]	Altrix Precision Temperature Management System	2016-12-02
PMN K152266 | DWJ STRYKER MEDICAL [STRYKER CORP.]	Altrix Precision Temperature Management System Reusable Adapter Cable; Reusable Patient Temperature Output Cable	2016-12-02
PMN K152266 | DWJ STRYKER MEDICAL [STRYKER CORP.]	Altrix Precision Temperature Management System Insulated Clik-Tite Hose; Insulated Colder Connector Hose	2016-12-02
DWJ STRYKER MEDICAL [STRYKER CORP.]	Altrix	2016-11-04
INO STRYKER MEDICAL [STRYKER CORP.]	Tru-Rize	2016-06-13
NZG STRYKER MEDICAL [STRYKER CORP.]	Nara	2015-05-11
FOA STRYKER MEDICAL [STRYKER CORP.]	CHG CPR Board	2015-01-29
PMN K140095 | INK STRYKER MEDICAL [STRYKER CORP.]	Prime Zoom Stretcher	2014-06-03
PMN K140095 | INK STRYKER MEDICAL [STRYKER CORP.]	Prime X Zoom	2014-06-03
PMN K140095 | INK STRYKER MEDICAL [STRYKER CORP.]	Prime Series Big Wheel Zoom Stretcher	2014-06-03
KME STRYKER MEDICAL [STRYKER CORP.]	Infant Warmer Pads	2013-12-09
INN STRYKER MEDICAL [STRYKER CORP.]	Prime TC	2013-09-13
INN STRYKER MEDICAL [STRYKER CORP.]	Prime TC with Swing Away	2013-09-13
PMN K113598 | FPO STRYKER MEDICAL [STRYKER CORP.]	PowerLOAD	2012-05-22
PMN K113598 STRYKER MEDICAL	POWER-LOAD COT FASTENER SYSTEM	2011-12-20
PMN K100585 | DWJ STRYKER MEDICAL [STRYKER CORP.]	RAPR ROUND	2011-12-07
PMN K100585 | DWJ STRYKER MEDICAL [STRYKER CORP.]	Mul T blanket	2011-12-07
PMN K103536 | FNL STRYKER MEDICAL [STRYKER CORP.]	iBed Wireless with iBed awareness	2010-12-27
PMN K103536 | FNL STRYKER MEDICAL [STRYKER CORP.]	Secure 3 with iWireless	2010-12-27
PMN K103536 | FNL STRYKER MEDICAL [STRYKER CORP.]	S3 bed with iWireless	2010-12-27
PMN K103536 | FNL STRYKER MEDICAL [STRYKER CORP.]	InTouchwith iWireless	2010-12-27
KIC STRYKER MEDICAL [STRYKER CORP.]	SofCare Chair Cushion	2010-11-02
KIC STRYKER MEDICAL [STRYKER CORP.]	SofCare Chair Cushion (Bariatric)	2010-11-02
ILO STRYKER MEDICAL [STRYKER CORP.]	Temp Pump Pro	2010-11-02
ILO STRYKER MEDICAL [STRYKER CORP.]	T-Pump	2010-11-02
ILO STRYKER MEDICAL [STRYKER CORP.]	Mul T Pad	2010-11-02
KMN STRYKER MEDICAL [STRYKER CORP.]	Michael Graves with Stryker Patient Chair- Highback, Comfort-Flex, Lowback, armless	2010-09-07
INM STRYKER MEDICAL [STRYKER CORP.]	Patient Chair	2010-04-29
FIA STRYKER MEDICAL [STRYKER CORP.]	Treatment Recliner	2010-04-29
FIA STRYKER MEDICAL [STRYKER CORP.]	Symmetry Plus Treatment Reclincer	2010-04-29
PMN K950889 | HDD STRYKER MEDICAL [STRYKER CORP.]	Model 4701 Maternity Bed	2008-03-31
PMN K950889 | HDD STRYKER MEDICAL [STRYKER CORP.]	LD304 Birthing Bed	2008-03-31
IKZ STRYKER MEDICAL [STRYKER CORP.]	Isolibrium	2006-11-30
FRK STRYKER MEDICAL [STRYKER CORP.]	TREATMENT RECLINER	2003-04-14
FRK STRYKER MEDICAL [STRYKER CORP.]	Symnmetry Plus Treatment Recliner	2003-04-14
FRK STRYKER MEDICAL [STRYKER CORP.]	Symmetry Plus Wall-Saver Recliner	2003-04-14
FRK STRYKER MEDICAL [STRYKER CORP.]	Symmetry Plus Rocker Recliner	2003-04-14
FRK STRYKER MEDICAL [STRYKER CORP.]	Symmetry Plus Narrow Treatment Recliner	2003-04-14
FPP STRYKER MEDICAL [STRYKER CORP.]	Rugged Transfer Flat	2002-09-16
FPP STRYKER MEDICAL [STRYKER CORP.]	RUGGED STAIR-PRO	2002-09-16
FPP STRYKER MEDICAL [STRYKER CORP.]	Evac Chair	2002-09-16
FMS STRYKER MEDICAL [STRYKER CORP.]	CUB	2001-08-08
FNJ STRYKER MEDICAL [STRYKER CORP.]	Platform Bed	1999-09-21
PMN K946149 STRYKER MEDICAL	STRYKER AGILITY INTENSIVE CARE BED	1995-03-14
FMW STRYKER MEDICAL [STRYKER CORP.]	XPRT Mattress Cover	1994-09-21
FMW STRYKER MEDICAL [STRYKER CORP.]	IsoFlex Mattress Cover	1994-09-21
FMW STRYKER MEDICAL [STRYKER CORP.]	CHG Prevention Surface Cover	1994-09-21
PMN K943864 STRYKER MEDICAL	STRYKER 8000 SURGERY STRETCHER	1994-08-25
PMN K935949 STRYKER MEDICAL	STRYKER 5000	1994-06-17
PMN K941738 STRYKER MEDICAL	STRYKER 5050 STRECHAIR	1994-05-06
PMN K940068 STRYKER MEDICAL	STRYKER OPERATING ROOM TABLE	1994-05-05
PMN K935297 STRYKER MEDICAL	STRYKER AMBULANCE COT MODEL 6060	1994-02-18
FNL STRYKER MEDICAL [STRYKER CORP.]	Spirit	1994-01-19
FNL STRYKER MEDICAL [STRYKER CORP.]	Spirit Select	1994-01-19
FNL STRYKER MEDICAL [STRYKER CORP.]	Spirit Plus	1994-01-19
FNL STRYKER MEDICAL [STRYKER CORP.]	Spirit One	1994-01-19
FNL STRYKER MEDICAL [STRYKER CORP.]	Secure 3 Bed	1994-01-19
FNL STRYKER MEDICAL [STRYKER CORP.]	S3 bed	1994-01-19
FNL STRYKER MEDICAL [STRYKER CORP.]	InTouch Bed	1994-01-19
FNL STRYKER MEDICAL [STRYKER CORP.]	GoBed II	1994-01-19
FNL STRYKER MEDICAL [STRYKER CORP.]	Epic II	1994-01-19
FNL STRYKER MEDICAL [STRYKER CORP.]	ELECTRIC ICU BED	1994-01-19
IOQ STRYKER MEDICAL [STRYKER CORP.]	Sofcare	1992-12-15
IOQ STRYKER MEDICAL [STRYKER CORP.]	Sofcare Plus	1992-12-15
IOQ STRYKER MEDICAL [STRYKER CORP.]	SPR Plus II	1992-12-15
IOQ STRYKER MEDICAL [STRYKER CORP.]	IsoFlex LAL	1992-12-15
IOQ STRYKER MEDICAL [STRYKER CORP.]	Duogard	1992-12-15
IOQ STRYKER MEDICAL [STRYKER CORP.]	Companion Pump	1992-12-15
IOQ STRYKER MEDICAL [STRYKER CORP.]	AIR+ Pump	1992-12-15
IKY STRYKER MEDICAL [STRYKER CORP.]	Ultra ComfortSE	1992-12-15
IKY STRYKER MEDICAL [STRYKER CORP.]	Ultra Comfort Mattress	1992-12-15
IKY STRYKER MEDICAL [STRYKER CORP.]	RapidCare	1992-12-15
IKY STRYKER MEDICAL [STRYKER CORP.]	ProForm	1992-12-15
IKY STRYKER MEDICAL [STRYKER CORP.]	Pioneer Stretcher Mattress	1992-12-15
IKY STRYKER MEDICAL [STRYKER CORP.]	Non-Powered Bariatric Support Surface	1992-12-15
IKY STRYKER MEDICAL [STRYKER CORP.]	IsoTour , mattress extender (accessory), turn assist upgrade kit (accessory)	1992-12-15
IKY STRYKER MEDICAL [STRYKER CORP.]	IsoFlex SE	1992-12-15
IKY STRYKER MEDICAL [STRYKER CORP.]	IsoFlex LAL	1992-12-15
IKY STRYKER MEDICAL [STRYKER CORP.]	Enhanced Comfort Mattress	1992-12-15
IKY STRYKER MEDICAL [STRYKER CORP.]	Emergency Relief Bed Mattress	1992-12-15
IKY STRYKER MEDICAL [STRYKER CORP.]	ComfortGel	1992-12-15
IKY STRYKER MEDICAL [STRYKER CORP.]	ComfortGel SE	1992-12-15
IKY STRYKER MEDICAL [STRYKER CORP.]	Blue Chip Medical Products Incc. GRZ, CHG Prevention Surface	1992-12-15
FZM STRYKER MEDICAL [STRYKER CORP.]	Surgi-Stool II	1992-12-15
FPO STRYKER MEDICAL [STRYKER CORP.]	Stryker Trauma Stretcher	1992-12-15
FPO STRYKER MEDICAL [STRYKER CORP.]	Stryker Transport Stretcher	1992-12-15
FPO STRYKER MEDICAL [STRYKER CORP.]	Stryker Stretcher Chair	1992-12-15
FPO STRYKER MEDICAL [STRYKER CORP.]	Stryker Fluoroscopy Stretcher	1992-12-15
FPO STRYKER MEDICAL [STRYKER CORP.]	Stryker Eye Surgery Stretcher	1992-12-15
FPO STRYKER MEDICAL [STRYKER CORP.]	Stryker Eye Stretcher Chair	1992-12-15
FPO STRYKER MEDICAL [STRYKER CORP.]	Stryker Cot Fastener	1992-12-15
FPO STRYKER MEDICAL [STRYKER CORP.]	Protective straps (accessory)	1992-12-15
FPO STRYKER MEDICAL [STRYKER CORP.]	Prime Series Big Wheel Stretcher	1992-12-15
FPO STRYKER MEDICAL [STRYKER CORP.]	Prime Series 5th Wheel Stretcher	1992-12-15
FPO STRYKER MEDICAL [STRYKER CORP.]	PowerPro-XT	1992-12-15
FPO STRYKER MEDICAL [STRYKER CORP.]	PowerPRO TL Ambulance Cot	1992-12-15
FPO STRYKER MEDICAL [STRYKER CORP.]	PowerPRO IT Ambulance Cot	1992-12-15
FPO STRYKER MEDICAL [STRYKER CORP.]	PowerPRO Ambulance Cot	1992-12-15
FPO STRYKER MEDICAL [STRYKER CORP.]	PerformancePRO	1992-12-15
FPO STRYKER MEDICAL [STRYKER CORP.]	PerformancePRO-XT	1992-12-15
FPO STRYKER MEDICAL [STRYKER CORP.]	Performance-LOAD	1992-12-15
FPO STRYKER MEDICAL [STRYKER CORP.]	MX-Pro Ambulance Cot	1992-12-15
FPO STRYKER MEDICAL [STRYKER CORP.]	M1 Roll-In System	1992-12-15
FPO STRYKER MEDICAL [STRYKER CORP.]	3019 Emergency Relief Bed	1992-12-15
FPO STRYKER MEDICAL [STRYKER CORP.]	"Gynnie" ObGyn Stretcher	1992-12-15
FOX STRYKER MEDICAL [STRYKER CORP.]	TPS2 Stand	1992-12-15
FOX STRYKER MEDICAL [STRYKER CORP.]	THC5 Stand	1992-12-15
FOX STRYKER MEDICAL [STRYKER CORP.]	Infusion Stand	1992-12-15
FOX STRYKER MEDICAL [STRYKER CORP.]	IV Pole	1992-12-15
FNM STRYKER MEDICAL [STRYKER CORP.]	IsoTour mattress, Isotour pump (accessory), mattress extender (accessory), turn assist upgrade kit (accessory)	1992-12-15
FNM STRYKER MEDICAL [STRYKER CORP.]	IsoAir mattress 2941	1992-12-15
FNM STRYKER MEDICAL [STRYKER CORP.]	Blue Chip Medical Inc. GRZ Pro	1992-12-15
PMN K920526 STRYKER MEDICAL	STRYKER DYNAMIC MATTRESS SYSTEM (DMS) MODEL #2500	1992-09-21
PMN K920704 STRYKER MEDICAL	STRYKER I.V. CADDY ACCESSORY DEVICE	1992-03-23
PMN K912237 STRYKER MEDICAL	STRYKER ECLIPSE WARMING STRETCHER	1991-07-30
FMP STRYKER MEDICAL [STRYKER CORP.]	SofCare Heel Care Boot	1977-12-29
FMP STRYKER MEDICAL [STRYKER CORP.]	Leg Positioner Disposables	1977-12-29
FMP STRYKER MEDICAL [STRYKER CORP.]	HeelCare Cushion	1977-12-29

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
20200929105235	Stadersand,Federal Republic of Germany -> New York, New York	MEDICAL EQUIPMENT FREIGHT PAYABLE IRELAND SHI PPED ON BOARD 25.09.2020	48 PCS
20200929105235	Stadersand,Federal Republic of Germany -> New York, New York	MEDICAL EQUIPMENT	48 PCS
2020092863641	Shanghai ,China (Mainland) -> Long Beach, California	FLUID TRAP	6 PKG
2020092666555	Shanghai ,China (Mainland) -> Los Angeles, California	TUBE FOR MEDICAL EQUIPMENT	20 PKG
2020092655097	Shanghai ,China (Mainland) -> Long Beach, California	CABLE LINE	38 CTN
2020092622020	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	96 PCS
2020092622020	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT SHIPPED ON BOARD 21.08.202 0	96 PCS
2020092622020	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	96 PCS
2020092622020	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	96 PCS
2020092677400	Stadersand,Federal Republic of Germany -> New York, New York	MEDICAL EQUIPMENT FREIGHT PAYABLE IRELAND SHI PPED ON BOARD 25.09.2020	48 PCS
2020092677400	Stadersand,Federal Republic of Germany -> New York, New York	MEDICAL EQUIPMENT	48 PCS
2020092629969	Yantian,China (Mainland) -> Long Beach, California	MANOMETER	31 CTN
2020092544041	Shanghai ,China (Mainland) -> Long Beach, California	CABLE LINE	38 CTN