10 results
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28ms
·
Sources: EU EUDAMED, US FDA
SIEMENS SI-400
FDA 510(k)
FDA Class 2
·Radiology
3M™ ESPE™
FDA UDI
3M COMPANY·30605861026759·3M™ ESPE™ Pedodontic Anterior Strip Crown Form,...
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193119717·HA PEEK EVOS Straight, ,13mmx9mmx 22mm , FLAT 5...
SPIVE NEEDLE SYSTEM, MODIFICATION
FDA 510(k)
FDA Class 2
·General Hospital
H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
MENTOR SMOOTH ROUND SPECTRUM
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·May 2, 2019
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·January 14, 2013
ACCU-CHEK D-TRONPLUS
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·November 19, 2010
11/13 S-ROM 40MM M SPEC+6
FDA Adverse Event
Injury
·DEPUY INTL., LTD - 8010379·Product code LPH·July 3, 2014
WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162
FDA Enforcement
Class II
·Terminated·CooperSurgical, Inc.·April 22, 2015