45 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DOPPLER MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
LISTER BANDAGE SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896075467·LISTER BANDAGE SCISSORS POWER CUT GOLD
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306837197·Talei Necklift Retractor Narrow, "Le Petit Bene...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306837180·Talei Necklift Retractor XL, "Benetrator Magnum...
K140347
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 6, 2021
K140347
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 6, 2021
LATEX EXAMINATION GLOVES-POWDERED, NONSTERILE
FDA 510(k)
FDA Class 1
·General Hospital
OPTIBOND SE
FDA 510(k)
FDA Class 2
·Dental
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 17, 2017
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 7, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 23, 2014
X8000 LIGHTSOURCE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·April 25, 2011
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 22, 2024
LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 13, 2023
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 17, 2024
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
LOGIC FEMORAL PS CEM LEFT SZ 3.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 5, 2025
LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·June 30, 2022
LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 5, 2024