12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KARL STORZ Flexible Video-Neuro-Endoscope System
FDA 510(k)
FDA Class 2
·Neurology
Eagle Sensitive Nitrile Examination Gloves
FDA UDI
Eagle Protect Pbc·09421024252816·Sensitive Nitrile Gloves, size XS, Nitrile Pow...
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515066908·Foerster Sponge Fcps, cvd, serr jaw, 9 1/2"
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690127697·Tibial Screw Drill- Hudson End
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321611120·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311611120·
RELIANCE SPINAL SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CONMED PRO2 PULSE REFLECTANCE OXIMETER, MODEL PRO-M
FDA 510(k)
FDA Class 2
·Cardiovascular
ATTAIN ABILITY
FDA Adverse Event
Malfunction
·MPRI·Product code OJX·October 10, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·June 17, 2011
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