16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MASTERGRAFT Contain
FDA 510(k)
FDA Class 2
·Orthopedic
HHM
FDA UDI
Oticon A/S·05707131279965·H160, DESIGNRITE 10 WL THP HHM
Statcorp Medical
FDA UDI
Statcorp Medical·10841522104596·BP CUFF,TL VINYL,1T,LG.ADULT-LONG,35-44CM,EA
Trulink
FDA UDI
Statcorp Medical·10841522123535·BP CUFF,TL VINYL,1T,LG.ADULT-LONG,35-44CM,5/BG
RDT3 HANDPIECE HEAD MODEL RDT3
FDA 510(k)
FDA Class 1
·Dental
4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PENUMBRA SMART COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·December 11, 2015
METRIX AIR
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·April 5, 2017
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013
PFC SIG RPF CEM FEM SZ 2 RT
FDA Adverse Event
Injury
·DEPUY RAYNHAM·Product code NJL·June 30, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 9, 2008
OT ULTRA 2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE GMBH·Product code NBW·July 15, 2020
OT ULTRA 2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE GMBH·Product code NBW·July 15, 2020
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 26, 2014
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016
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