21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0100260·Tray Insert, Lumbar Screw Rack 10 x 10
Intess C
FDA UDI
Kalitec Direct LLC·B07309K0100260·Assembly, Caddie, Implants, Hinged
EMBOGOLD MICROSPHERE
FDA 510(k)
FDA Class 2
·Neurology
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964054363·Endo Carry-on Procedure Kit Includes Basin, Enz...
COMPRESSOR TOP HANDLE
FDA UDI
Osteocentric Technologies, Inc.·00810097802414·COMPRESSOR TOP HANDLE
TERUMO CORP.
FDA registration
TERUMO CORP.·28 products·🇯🇵 Japan
VersaRate
FDA UDI
EMED TECHNOLOGIES CORPORATION·00817708020540·Variable Infusion Flow Rate Controller set
General Instrument
FDA UDI
ORTHOPEDIATRICS CORP.·00841132126509·Pedi Plate Holding Forceps
APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
3D-MSPECT
FDA 510(k)
FDA Class 2
·Radiology
ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·August 21, 2019
AXSYM DIGOXIN III
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013
UNKNOWN DEPUY CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·March 2, 2011
ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073
FDA Recall
Open, Classified
·Luminex Corporation·Product code OOI·February 20, 2019
ACHIEVE ADVANCE MAPPING CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DRF·December 20, 2024
HELICAL BLADE COUPLING SCREW
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code LXH·May 19, 2017
FREEDOM60 SYRINGE INFUSION SYSTEM
FDA Adverse Event
Malfunction
·KORU MEDICAL SYSTEMS·Product code FRN·May 1, 2023
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024