9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PERMANENT PACING LEADS, MODIFICATION
FDA 510(k)
FDA Class 3
·Cardiovascular
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100011·BARRAQUER WIRE SPECULUM LARGE WITH TABS
SPRINGFUSOR 10R
FDA 510(k)
FDA Class 2
·General Hospital
STANDARD BREAST BOARDS; DELUXE BREAST BOARD
FDA 510(k)
FDA Class 2
·Radiology
WORKHORSE II BALLOON CATHETER
FDA Adverse Event
Malfunction
·ANGIODYNAMICS, INC.·Product code LIT·April 27, 2007
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·November 17, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 6, 2014
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·December 7, 2012
OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370
FDA Enforcement
Class II
·Ongoing·Osteomed, LLC·December 15, 2021