11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Pelvic Floor Muscle Stimulator
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
N/A
FDA UDI
inomed Medizintechnik GmbH·EINO2307679·MicroMacroElectrode 0.8 mm with depth stop., 5 ...
DELTA XTEND
FDA UDI
DEPUY (IRELAND)·10603295116004·DELTA Xtend CUP IMPACTOR TIP
FIDJI SMALL CEMENT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SilverStream Gel
FDA 510(k)
FDA Unclassified
·Unknown
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
CAPD SOLUTION TRANSFER SET (SHORT) FOR UV-FLASH
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·November 17, 2008
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·August 23, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013
CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·April 17, 2019
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020