30 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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M5 Recorder
FDA 510(k)
FDA Class 2
·Cardiovascular
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112915·CORNEAL TREPHINE BLADE7.5MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112496·BARRON VACUUM TREPHINE 7.5MM
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113431·CRESCENT KNIFE DOUBLE BEVEL (BX/5)
3.0 RIO® ROBOTIC ARM - MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·January 30, 2020
PORTA IP SOLDER V-1
FDA 510(k)
FDA Class 2
·Dental
MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992
FDA 510(k)
FDA Class 2
·Clinical Chemistry
WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NGV·March 15, 2024
VITROS CHEMISTRY PRODUCTS SALICYLATE SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code DKJ·October 8, 2008
UNKNOWN TRIDENT CUP
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code LPH·August 5, 2011
PFC SIG RPF CEM FEM SZ 5 RT
FDA Adverse Event
Injury
·1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC·Product code NJL·July 2, 2013
AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code PCU·August 26, 2024
AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code PCU·August 26, 2024
1823260-2017-01819
FDA Adverse Event
Malfunction
·August 25, 2017
AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code PCU·August 26, 2024
THORATEC® HEARTMATE 3® LVAS IMPLANT KIT
FDA Adverse Event
Death
·THORATEC CORPORATION·Product code DSQ·September 11, 2024
THORATEC® HEARTMATE 3® LVAS IMPLANT KIT
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·September 11, 2024
PENTAX
FDA Adverse Event
Injury
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·July 5, 2024
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·September 23, 2024
AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code PCU·June 10, 2024