40 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OSSEOFUSE DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Medetz Surgical Instruments
FDA UDI
Medetz Surgical Instruments LLC·G2231105770·Osher y-hook lens manipulator, 4 3/4", straight...
BODYGEM, MODEL HB211
FDA 510(k)
FDA Class 2
·Anesthesiology
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
WAVEWRITER ALPHA 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 6, 2024
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 14, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·June 1, 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
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
LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 11, 2024
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 22, 2024
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 26, 2023
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6+ R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 16, 2024
OPTETRAK LOGIC
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 7, 2023
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 11, 2023