12 results
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35ms
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Sources: EU EUDAMED, US FDA
LH IRMA IMMUNOMAG
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Bioseal Inc.
FDA UDI
BIOSEAL·00630094191102·Latex Elastic Bands
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756393379·ABLATION PACK
InCompass®
FDA UDI
ZIMMER SPINE, INC.·00889024402041·
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668112304·SURG-I-BAND BROWN
BR2000 BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919014546·BR1-19110-50
ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR
FDA 510(k)
FDA Class 2
·Anesthesiology
MICROSTREAM ORAL NASAL CANNULA FILTERLINE
FDA 510(k)
FDA Class 2
·Anesthesiology
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·January 11, 2013
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·November 30, 2010
ELLIPSE ST DR, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·July 2, 2014
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024