10 results
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18ms
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Sources: EU EUDAMED, US FDA
EXTENDED TUMOR CALIPER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE
FDA 510(k)
FDA Class 2
·Physical Medicine
EYEGLASS FRAMES
FDA 510(k)
FDA Class 1
·Ophthalmic
MINI-INFUSER RADIATION STERILIZED EXTENSION SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 7, 2021
OPTETRAK
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 2, 2022
PROTECTA XT VR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code LWS·October 31, 2012
AL-III W/FOOT CONTROL
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code GEY·October 11, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·August 11, 2010
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