11 results
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21ms
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Sources: EU EUDAMED, US FDA
DRY TIME
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756398541·UNIVERSAL SURGERY PACK
NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
ENTEC EVAC PLASMA WAND
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·July 12, 2023
SYSTEM 7 RECIP SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·January 11, 2013
5.5 MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX)
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY PUERTO RICO·Product code HRX·November 22, 2010
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 2, 2014
VITEK® 2 GRAM-POSITIVE IDENTIFICATION ID TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC·Product code LQL·February 2, 2017
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