23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CRANIOCAP
FDA 510(k)
FDA Class 2
·Neurology
Preat
FDA UDI
Preat Corporation·00842092171318·NobelActive™/Conical-compatible NP X 4.5mm Enga...
Implant Prosthetics
FDA UDI
Preat Corporation·00842092117149·Nobel Active/Conical NP x 4.5mm Titanium Base
ELIMINATOR
FDA UDI
Conmed Corporation·20653405052583·CONMED ELIMINATOR 3-Stage Pyloric/Colonic PET B...
EliA ANA Positive Control 2500/5000
FDA UDI
Phadia AB·07333066013145·EliA ANA Positive Control 2500/5000
MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT
FDA 510(k)
FDA Class 2
·Dental
HARDYDISK, PIPERACILLIN/TAZOBACTAM, 110MCG
FDA 510(k)
FDA Class 2
·Microbiology
IM REAMER, AO FITTING BIXCUT 8,0X480 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·July 15, 2020
VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
FDA Adverse Event
Injury
·ALCON - COUVREUR N.V./ALCON - BELGIUM·Product code LZP·November 16, 2022
VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
FDA Adverse Event
Injury
·ALCON - COUVREUR N.V./ALCON - BELGIUM·Product code LZP·November 16, 2022
VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
FDA Adverse Event
Injury
·ALCON - COUVREUR N.V./ALCON - BELGIUM·Product code LZP·November 17, 2022
VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
FDA Adverse Event
Injury
·ALCON - COUVREUR N.V./ALCON - BELGIUM·Product code LZP·November 16, 2022
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 13, 2013
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·February 17, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC·Product code JAA·February 21, 2008
L3C1950 - UNO OR/SECUREMENT
FDA Adverse Event
Malfunction
·UNOMEDICAL S.R.O.·Product code KGX·September 14, 2021
L3C1950 - UNO OR/SECUREMENT
FDA Adverse Event
Malfunction
·UNOMEDICAL S.R.O.·Product code KGX·September 14, 2021
ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 20mm (60 Fr), length 4cm; product code/end item #000861 and #000867 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
FDA Recall
Terminated
·Conmed Endoscopic Technologies, Inc.·Product code KNQ·April 16, 2007
Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 6, 2016
Brilliance 64 Model # 728231, computed tomography x-ray system
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·August 14, 2019