12 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INFRARED THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
n/a
FDA UDI
HANS RUDOLPH, INC.·00874750007295·1410 2WAY SM 22/15 W/INF MADPT
IRIS Anterior Cervical Plate System
FDA UDI
Life Spine, Inc.·00190837060718·Iris 4-5 Level ACP Caddy
CapSure® Spine System
FDA UDI
Spine Wave, Inc.·10840642105216·PS2 Screw 7.5mm x 60mm
BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II)
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·August 9, 2021
MEDLINE EXCEL RECLINCER WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
VISUALIZE: VASCULAR
FDA 510(k)
FDA Class 2
·Radiology
NITE GUARD
FDA Adverse Event
Malfunction
·RANIR, LLC·Product code OBR·May 1, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 15, 2013
SHILEY PEDIATRIC
FDA Adverse Event
Injury
·COVIDIEN/FORMERLY TYCO·Product code JOH·June 2, 2011
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025