56 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091033083·Baltic Denture System BDLoad ↓ Lm6 PLSEum4DFl D...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319718162·Martini-Hayden Curette 5-1/4" (13.1cm), round, ...
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0380830·T-Handle, Ratcheting, Quarter Square Collar
CARTO XP EP NAVIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800
FDA 510(k)
FDA Class 2
·General Hospital
OPTETRAK
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 2, 2022
LOGIC TIBIA PS MOD INSRT SZ 3 15MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 2, 2022
LOGIC TIBIA PS MOD INSRT SZ 5 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 23, 2022
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 1, 2013
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·February 28, 2011
HYALAMER 10D 52OD X 28ID
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·April 22, 2008
OPTETRAK
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 4, 2022
LOGIC TIBIA PS MOD INSRT SZ 4 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 3, 2024
LOGIC TIBIA PS MOD INSRT SZ 5 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 10, 2023
LOGIC TIBIA PS MOD INSRT SZ 5 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 10, 2023
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 11, 2024
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·January 6, 2025
PROGREAT
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DQO·March 5, 2024
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 11, 2024