11 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Nitrile Patient Examination Powder Free Glove, Textured, Black
FDA 510(k)
FDA Class 1
·General Hospital
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304457300·
SPINESMITH CYNCH SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SHARPS TANK REUSABLE SHARPS CONTAINER
FDA 510(k)
FDA Class 2
·General Hospital
ENRHYTHM MRI
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NVZ·October 10, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·June 17, 2011
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
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