10 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FINGERTIP PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
LINK Instruments - Rasps, compressors and broaches
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575286638·Orthopaedic prosthesis instrument, reusable - G...
FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000
FDA 510(k)
FDA Class 2
·General Hospital
ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 3, 2024
OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 4/3 X 13MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·September 29, 2025
INSERT/EXTRACTOR F/INFANT-HIP-PL+MINI-IN
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWB·May 24, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 30, 2014
CAPSURE SENSE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm x 18, Part Number 9080-18T; K-Wire Non-Threaded 1.4mm x 18, Part Number 9080-18U; 1.4mm x 24 Threaded Guide Wire, Part Number 9080-24T; K-Wire Non-Threaded 24, Part Number 9080-24U; Blunt K-Wire, 18 inches, Threaded, Part Number 9080B-18T; Blunt K-Wire, 18 inches, Unthreaded, Part Number 9080B-18U; Blunt K-Wire, 24 inches, Unthreaded, Part Number 9080B-24U; 1.4mm x 18 Blunt Threaded Nitinol Guide Wire, Part Number 9080B-N-18T; 1.4mm x 18" Blunt Non-Threaded Nitinol Guide Wire, Part Number 9080B-N-18U; Lodestar K-wire Non-Threaded, 18, Part Number 9080L-18U; 1.4mm x 18 Threaded Nitinol Guide Wire, Part Number 9080-N-18T; 1.4mm x 18 Non-Threaded Nitinol Guide Wire, Part Number 9080-N-18U The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone
FDA Enforcement
Class II
·Terminated·Amendia, Inc·December 28, 2016