15 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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PROBEAT-V
FDA 510(k)
FDA Class 2
·Radiology
AGC TRADITION KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304241213·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587P1511320·15mm PLIF Implant 11mm Wide 32mm Length
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587P15113270·15mm PLIF Implant 11mm Wide 32mm Length 7 Degrees
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869607728·TELIX K Ti Cage 11x32mm 5°
Endo-Model Knee System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575260102·Instrument tray - General instrument
Statcorp Medical
FDA UDI
Statcorp Medical·10841522104435·BP CUFF,TL VINYL,1T,SMALL ADULT,18-26CM,EA
Trulink
FDA UDI
Statcorp Medical·10841522123443·BP CUFF,TL VINYL,1T,SMALL ADULT,18-26CM,5/BG
GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (BLUE, WHITE, PINK)
FDA 510(k)
FDA Class 1
·General Hospital
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013
HIP HEAD, 10/12 TAPER, 28MM, +0MM
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code KWY·June 30, 2011
COLIBRI
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·October 8, 2014
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014
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