19 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PERMANENT PACING PAD, MODIFICATION
FDA 510(k)
FDA Class 3
·Cardiovascular
VERTE-STACK® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902984198·SPACER 8915008 8MM ADD ON FLAT SMALL
ZAVATION
FDA UDI
Zavation LLC·00842166189461·5.0 x 8mm Occipital Screw
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540393869·DESCRIPTION SHIELD ''NEURO SYSTEM''
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100028·BLUMENTHAL SPECULUM X-HEAVY
FLEXIBLE INTRACARDIAC SUCTION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDOTHRED ADJUSTABLE STABILITLY THEREAD
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·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
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 20, 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