11 results
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18ms
·
Sources: EU EUDAMED, US FDA
TRANSVAGINAL TRANSDUCER ASSEMBLY
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
N/A
FDA UDI
Smith & Nephew, Inc.·00885556601006·SOD CANNULA 10MM WITH 4.5MM SLOT
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221111302·3M™ Unitek™ Bracket Positioning Gauge Two, 900-...
STIMULUS/DISSECTION INSTRUMENTS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
SNAP-RING FOR 52MM OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWB·December 4, 2007
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.MED·Product code OYC·June 27, 2014
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWY·January 8, 2013
ADVANTA BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·November 9, 2010
AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
FDA Enforcement
Class II
·Terminated·BioHorizons Implant Systems Inc·December 26, 2012
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·November 30, 2021