23 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMMULITE 2000 3GALLERGY SPECIFIC IGE
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018
IMMULITE 2000 SPECIFIC ALLERGENS
FDA 510(k)
FDA Class 2
·Immunology
IMMULITE 2000 3GALLERGY SPECIFIC IGE
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018
PullUp Probe Cover Kit
FDA UDI
PROTEK MEDICAL PRODUCTS, INC.·00841912105366·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694000277·1.2mm x 6mm OMI Orthodontic Anchor Screw
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0112060·Tap, 6.50mm
VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 060 mm
FDA UDI
icotec AG·07640172551783·VADER Pedicle System, Rod, Carbon/PEEK, Curved,...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0112060·Tap, 8.5 mm
InSePtion MIS Fixation System
FDA UDI
Kalitec Direct LLC·B07314K0112060·Punch, 6 and 8 mm
PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
I-STAT ACT CELITE CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JBP·December 10, 2012
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·March 26, 2013
SPRINT FIDELIS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 16, 2011
ACUVUE OASYS W/HYDRACLEAR
FDA Adverse Event
Injury
·VISTAKON·Product code LPL·March 28, 2008
THORATEC® HEARTMATE 3® LVAS IMPLANT KIT
FDA Adverse Event
Death
·THORATEC CORPORATION·Product code DSQ·April 10, 2026
THORATEC® HEARTMATE 3® LVAS IMPLANT KIT
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·April 10, 2026
RESONANCE STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FAD·October 20, 2025
CryoValve, Alt Pulmonary Valve & Conduit
FDA Recall
Terminated
·Cryolife Inc·Product code MIE·November 19, 2003
Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·February 28, 2018