11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KENDALL PEDIATRIC URINE METER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Maestro®
FDA UDI
Ortho Organizers, Inc.·00190707046910·.018 LL6 NC Std -10T 0A 0O
TC-PLUS POROUS FEMORAL COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
Intraosseous infusion device
FDA 510(k)
FDA Class 2
·General Hospital
TRAPEZOID TIBIAL TRAY SZ 5F/4T
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 5, 2025
TRIDENT CONSTRAINED INSERT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·November 23, 2010
DEPUY ASR XL FEM IMP SIZE 53
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.·Product code KWA·July 2, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·December 14, 2012
VITEK® 2 GN TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX INC.·Product code JTO·December 13, 2016
Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L, CF-Q150I, CF-Q150L, CF-Q160S, CF-Q180AI, CF-Q180AL. 510(k) Numbers: K954451, K112680, K100584, K051645, K111756, K001241, K911278.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L, CF-Q150I, CF-Q150L, CF-Q160S, CF-Q180AI, CF-Q180AL. 510(k) Numbers: K954451, K112680, K100584, K051645, K111756, K001241, K911278.
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FET·September 25, 2023