18 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPINAUT-P
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Globe Scientific
FDA UDI
GLOBE SCIENTIFIC INC.·00840095658850·Filter pipette tips, 100uL, low retention, 96/r...
Oticon
FDA UDI
Oticon A/S·05707131283573·RIA2, BTE 13 WL 100 STG
SSW CARBIDE TRIMMING AND FINISHING
FDA UDI
Ss White Burs, Inc.·D6901509152·12 BLADE FINISHING CARBIDE 7104 - 5 PACK
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100080·TEMPORAL SPECULUM OPEN WIRE
Scorpio
FDA UDI
Howmedica Osteonics Corp.·07613153867883·Posterior Stabilized Tibial Insert
INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650
FDA 510(k)
FDA Class 2
·Cardiovascular
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY]
FDA 510(k)
FDA Class 2
·Cardiovascular
GMK SPHERE FEMORAL COMPONENT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 22, 2017
BD 1ML SYRINGE LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 11, 2020
BD MULTI-CHECK CD4 LOW CONTROL
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 29, 2023
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·August 24, 2016
MISAGO RX Self Expanding Peripheral Stem
FDA Enforcement
Class II
·Terminated·Terumo Medical Corp·December 7, 2016
RESPIRATORY HUMIDIFIER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 26, 2015
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·June 6, 2013
PFCMOD C/S STAB INS SZ4 12.5MM
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·June 29, 2011
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008
BD MULTI-CHECK CD4 LOW CONTROL
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 16, 2023