15 results
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28ms
·
Sources: EU EUDAMED, US FDA
SMD-Sr90-DA Radionuclide Brachytherapy Source
FDA 510(k)
FDA Class 2
·Radiology
Back-N-Black
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357632060·
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180529645·Sigma LTP Shim, Long, Narrow
LINK Instruments - Drills, reamers and saw blades
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575397600·Fluted surgical drill bit, reusable - Megasyste...
RAUMEDIC- ICP-MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø56
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·July 21, 2017
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·December 7, 2023
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 25, 2025
METRIX AIR
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·February 21, 2017
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·October 10, 2014
MULTI-LINK 8
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code MAF·June 11, 2013
LCS COMP RPS INS LG 10MM
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code NJL·July 8, 2011
VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
FDA Enforcement
Class II
·Terminated·VGI Medical, LLC·June 13, 2018
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