Stryker Medical Elm Valley Drive Facility

FDA Filings

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

FDA Registration(s)

• Registration Number: 3013965492
• FEI Number: 3013965492
• Name: Stryker Medical Elm Valley Drive Facility
• Owner & Operator: STRYKER CORP.
• Contact Address: 1901 Romence Pkwy ; Portage MI 49002 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 6938 Elm Valley Drive ; Kalamazoo, MI 49009 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
OSI Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	MV3 Bariatric Bed, Patient Helper (Accessory), IV Pole (Accessory)	2019-07-09
PMN K180834 | FLL Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Altrix Precision Temperature Management System	2018-08-13
PMN K180834 | FLL Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Altrix Precision Temperature Management System Reusable Adapter Cable; Reusable Patient Temperature Output Cable	2018-08-13
PMN K180834 | FLL Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Altrix Precision Temperature Management System Insulated Clik-Tite Hose; Insulated Colder Connector Hose	2018-08-13
PMN K180834 | DWJ Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Altrix Precision Temperature Management System	2018-08-13
PMN K180834 | DWJ Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Altrix Precision Temperature Management System Reusable Adapter Cable; Reusable Patient Temperature Output Cable	2018-08-13
PMN K180834 | DWJ Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Altrix Precision Temperature Management System Insulated Clik-Tite Hose; Insulated Colder Connector Hose	2018-08-13
PMN K171149 | DWJ Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Altrix Temperature Management Wrap	2018-05-01
PMN K152266 | FLL Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Altrix Precision Temperature Management System	2016-12-02
PMN K152266 | FLL Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Altrix Precision Temperature Management System Reusable Adapter Cable; Reusable Patient Temperature Output Cable	2016-12-02
PMN K152266 | FLL Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Altrix Precision Temperature Management System Insulated Clik-Tite Hose; Insulated Colder Connector Hose	2016-12-02
PMN K152266 | DWJ Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Altrix Precision Temperature Management System	2016-12-02
PMN K152266 | DWJ Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Altrix Precision Temperature Management System Reusable Adapter Cable; Reusable Patient Temperature Output Cable	2016-12-02
PMN K152266 | DWJ Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Altrix Precision Temperature Management System Insulated Clik-Tite Hose; Insulated Colder Connector Hose	2016-12-02
NZG Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Nara	2015-05-11
PMN K140095 | INK Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Prime Zoom Stretcher	2014-06-03
PMN K140095 | INK Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Prime X Zoom	2014-06-03
PMN K140095 | INK Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Prime Series Big Wheel Zoom Stretcher	2014-06-03
KME Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Infant Warmer Pads	2013-12-09
INN Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Prime TC	2013-09-13
INN Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Prime TC with Swing Away	2013-09-13
PMN K113598 | FPO Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	PowerLOAD	2012-05-22
PMN K100585 | DWJ Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	RAPR ROUND	2011-12-07
PMN K100585 | DWJ Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Mul T blanket	2011-12-07
PMN K103536 | FNL Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	iBed Wireless with iBed awareness	2010-12-27
PMN K103536 | FNL Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Secure 3 with iWireless	2010-12-27
PMN K103536 | FNL Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	S3 bed with iWireless	2010-12-27
PMN K103536 | FNL Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	InTouchwith iWireless	2010-12-27
KIC Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	SofCare Chair Cushion	2010-11-02
KIC Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	SofCare Chair Cushion (Bariatric)	2010-11-02
ILO Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Temp Pump Pro	2010-11-02
ILO Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	T-Pump	2010-11-02
ILO Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Mul T Pad	2010-11-02
KMN Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Michael Graves with Stryker Patient Chair- Highback, Comfort-Flex, Lowback, armless	2010-09-07
PMN K950889 | HDD Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Model 4701 Maternity Bed	2008-03-31
PMN K950889 | HDD Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	LD304 Birthing Bed	2008-03-31
IKZ Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Isolibrium	2006-11-30
FRK Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	TREATMENT RECLINER	2003-04-14
FRK Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Symnmetry Plus Treatment Recliner	2003-04-14
FRK Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Symmetry Plus Wall-Saver Recliner	2003-04-14
FRK Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Symmetry Plus Rocker Recliner	2003-04-14
FRK Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Symmetry Plus Narrow Treatment Recliner	2003-04-14
FPP Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Rugged Transfer Flat	2002-09-16
FPP Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	RUGGED STAIR-PRO	2002-09-16
FPP Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Evac Chair	2002-09-16
FMS Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	CUB	2001-08-08
FNL Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Spirit	1994-01-19
FNL Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Spirit Select	1994-01-19
FNL Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Spirit Plus	1994-01-19
FNL Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Spirit One	1994-01-19
FNL Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Secure 3 Bed	1994-01-19
FNL Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	S3 bed	1994-01-19
FNL Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	InTouch Bed	1994-01-19
FNL Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	GoBed II	1994-01-19
FNL Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Epic II	1994-01-19
FNL Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	ELECTRIC ICU BED	1994-01-19
IOQ Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Sofcare	1992-12-15
IOQ Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Sofcare Plus	1992-12-15
IOQ Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	SPR Plus II	1992-12-15
IOQ Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	IsoFlex LAL	1992-12-15
IOQ Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Duogard	1992-12-15
IOQ Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Companion Pump	1992-12-15
IOQ Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	AIR+ Pump	1992-12-15
IKY Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Ultra ComfortSE	1992-12-15
IKY Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Ultra Comfort Mattress	1992-12-15
IKY Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	RapidCare	1992-12-15
IKY Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	ProForm	1992-12-15
IKY Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Pioneer Stretcher Mattress	1992-12-15
IKY Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Non-Powered Bariatric Support Surface	1992-12-15
IKY Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	IsoTour , mattress extender (accessory), turn assist upgrade kit (accessory)	1992-12-15
IKY Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	IsoFlex SE	1992-12-15
IKY Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	IsoFlex LAL	1992-12-15
IKY Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Enhanced Comfort Mattress	1992-12-15
IKY Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Emergency Relief Bed Mattress	1992-12-15
IKY Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	ComfortGel	1992-12-15
IKY Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	ComfortGel SE	1992-12-15
IKY Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Blue Chip Medical Products Incc. GRZ, CHG Prevention Surface	1992-12-15
FZM Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Surgi-Stool II	1992-12-15
FPO Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Stryker Trauma Stretcher	1992-12-15
FPO Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Stryker Transport Stretcher	1992-12-15
FPO Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Stryker Stretcher Chair	1992-12-15
FPO Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Stryker Fluoroscopy Stretcher	1992-12-15
FPO Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Stryker Eye Surgery Stretcher	1992-12-15
FPO Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Stryker Eye Stretcher Chair	1992-12-15
FPO Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Stryker Cot Fastener	1992-12-15
FPO Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Protective straps (accessory)	1992-12-15
FPO Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Prime Series Big Wheel Stretcher	1992-12-15
FPO Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Prime Series 5th Wheel Stretcher	1992-12-15
FPO Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	PowerPro-XT	1992-12-15
FPO Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	PowerPRO TL Ambulance Cot	1992-12-15
FPO Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	PowerPRO IT Ambulance Cot	1992-12-15
FPO Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	PowerPRO Ambulance Cot	1992-12-15
FPO Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	PerformancePRO	1992-12-15
FPO Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	PerformancePRO-XT	1992-12-15
FPO Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Performance-LOAD	1992-12-15
FPO Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	MX-Pro Ambulance Cot	1992-12-15
FPO Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	M1 Roll-In System	1992-12-15
FPO Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	3019 Emergency Relief Bed	1992-12-15
FPO Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	"Gynnie" ObGyn Stretcher	1992-12-15
FOX Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	TPS2 Stand	1992-12-15
FOX Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	THC5 Stand	1992-12-15
FOX Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Infusion Stand	1992-12-15
FOX Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	IV Pole	1992-12-15
FNM Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	IsoTour mattress, Isotour pump (accessory), mattress extender (accessory), turn assist upgrade kit (accessory)	1992-12-15
FNM Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	IsoAir mattress 2941	1992-12-15
FNM Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Blue Chip Medical Inc. GRZ Pro	1992-12-15
FMP Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	SofCare Heel Care Boot	1977-12-29
FMP Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	Leg Positioner Disposables	1977-12-29
FMP Stryker Medical Elm Valley Drive Facility [STRYKER CORP.]	HeelCare Cushion	1977-12-29