17 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·March 26, 2013
CONTOUR USB
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·December 14, 2012
CONTOUR NEXT
FDA Adverse Event
Injury
·BAYER HEALTHCARE LLC·Product code NBW·July 27, 2012
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089402908·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776406288·Kelly Retractor 9 3/4", 2 1/2" x 3"
FORCETRIAD ELECTROSURGICAL GENERATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BREEZY WHEELCHAIR, MODEL 300
FDA 510(k)
FDA Class 1
·Physical Medicine
DONJOY
FDA UDI
DJO, LLC·00888912005456·COLD PAD,MCGUIRE,LOOP,NS,RH
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·May 8, 2013
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·May 18, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 14, 2008
TRIFORCE¿ PERIPHERAL CROSSING SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·August 1, 2015
LOCKSCR Ø5 SELF-TAP L36 TAN
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·January 1, 2020
CORTSCR Ø4.5 SELF-TAP L36 TI
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·December 31, 2019
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018