12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM...
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HemoCue® Hb 301 Microcuvettes
FDA UDI
Hemocue AB·17311091118070·HemoCue Hb 301 Microcuvettes 4x75 vial
ELBOW FIXATOR
FDA UDI
ORTHOFIX SRL·18053504364795·Component. Not for sale. Used for reporting Dir...
Flexitron
FDA UDI
Nucletron B.V.·08717213026537·Flexitron Transfer Tube for Metal Needles (2)
STAYHEALTHY BODY COMPOSITION MONITOR-BCM
FDA 510(k)
FDA Class 2
·Cardiovascular
SCS CLARIS SPINAL SCREWS, TYPES V,G,E
FDA 510(k)
FDA Class 2
·Orthopedic
Ascendant
FDA UDI
Choice Spine, LP·10885862260888·
BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code GIM·June 14, 2024
Q2 MULTIPORT MANIFOLD EXTENSION LINE
FDA Adverse Event
Malfunction
·QUEST MEDICAL, INC.·Product code FPA·May 7, 2013
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·June 2, 2011
POLYFLUX LR CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIALYSATOREN GMBH·Product code MSF·August 14, 2008
ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013