9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RSI-MRI+
FDA 510(k)
FDA Class 2
·Radiology
INERTIA PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VALEO SPACER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MODEL NOT SPECIFIED
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 21, 2014
M2A TAPER 37/28MM LINER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 26, 2013
STAY SAFE/LUER LOCK ADAPTER 4 IN.
FDA Adverse Event
Malfunction
·REYNOSA MFG·Product code KDJ·July 19, 2011
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
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026