33 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRISMATIK CLINICAL ZIRCONIA
FDA 510(k)
FDA Class 2
·Dental
Nova
FDA UDI
PURELIFE, LLC·D79010601041·Nova Nitrile Powder-Free, Large, Super-stretchy...
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040128213·EXPANSION SCREW SAGITAL BENT DOWN
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037312674·HUDSON EXTENSION CONNECT
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190806·FEMORAL TRIAL STUD
PRIME ECG SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
CANDELA LONG PULSE ND:YAG
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INGEVITY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NVN·September 18, 2024
ULTRAFLEX TRACHEOBRONCHIAL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code JCT·December 27, 2023
SPACEOAR VUE? SYSTEM - 10ML
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OVB·May 7, 2026
PUMP 371 14F LT CMR SET
FDA Adverse Event
Death
·ABIOMED, INC. - 1220648·Product code OZD·January 28, 2026
VM8
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·March 20, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·April 15, 2011
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 10, 2008
SPACEOAR VUE? SYSTEM - 10ML
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OVB·May 7, 2026
2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·November 30, 2016
INGEVITY?+
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NVN·November 7, 2024
SYMMETRY GEN MODEL 8103
FDA Adverse Event
Injury
·Product code MUZ·December 22, 2020
VIGILANT? X4 CRT-D
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code NIK·June 7, 2024
INGEVITY?+
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NVN·October 8, 2024