15 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
SMOOTH STEINMANN PINS, DOUBLE END BAYONET POINT
FDA UDI
Biomet Orthopedics, LLC·00887868016813·
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J0111631200000·CONTEC lcr disposable tube / For CONTEC lcr ret...
FASTTAKE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·September 5, 2002
COLOR LCD MONITOR, RADIFORCE, MODEL RX210
FDA 510(k)
FDA Class 2
·Radiology
CORIN BIOLOX DELTA FEMORAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
MACROPLASTIQUE IMPLANTS
FDA Adverse Event
Malfunction
·UROPLASTY, LLC·Product code LNM·September 21, 2016
STARKEY
FDA UDI
Starkey Laboratories, Inc.·00842318177032·
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 25, 2025
SYRINGE 0.3ML 29GA 1/2IN BLS 400 SG
FDA Adverse Event
Malfunction
·EMBECTA MEDICAL I LLC - HOLDREGE, NE·Product code FMF·April 9, 2025
BD SAFETYGLIDE
FDA Adverse Event
Malfunction
·EMBECTA MEDICAL I LLC·Product code MEG·December 4, 2025
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·June 11, 2013
VITALITY
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 15, 2011
TRIDENT HEMISPHERICAL SOLID BK 48MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MRA·September 16, 2008
CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
FDA Enforcement
Class II
·Terminated·Civco Medical Instruments Co. Inc.·November 25, 2015