11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARC SURGICAL BIOTRAK PIN SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PMMA disc
FDA UDI
Dentsply International Inc.·D00180716160·
Epimed
FDA UDI
EPIMED INTERNATIONAL, INC·00818788023674·RX-2™ Coudé® Epidural Needle 13g TW x 6.0"
INDUO BLOOD GLUCOSE METER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE
FDA 510(k)
FDA Class 2
·General Hospital
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 11, 2022
CAPSURE Z NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·April 22, 2013
FLEXICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·April 28, 2011
PROLIEVE THERMODILITATION KIT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·July 9, 2008
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·October 7, 2020
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018