13 results
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26ms
·
Sources: EU EUDAMED, US FDA
NECKTRAC
FDA 510(k)
FDA Class 1
·Orthopedic
Bioplate®
FDA UDI
Bioplate, Inc.·M3848130170·Emergency Screw - Ø1.8 mm x 6 mm
SYS*STIM 240
FDA 510(k)
FDA Class 2
·Physical Medicine
MEDIGROUP KEY TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MAXCUT DIAMOND BURS (6/pk) CRS 6813-017
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D7781006813171·MAXCUT DIAMOND BURS (6/pk) Shape: Amalgam; Size...
MAXCUT DIAMOND BURS (6/pk) MED 813-017
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D778100813171·MAXCUT DIAMOND BURS (6/pk) Shape: Amalgam; Size...
L.C. 5000/CE NITROGL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·July 27, 2009
NITRO I.V. DC INF. SET W/LB TBG
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 16, 2011
L.C. 5000/CE NITROGLYCERIN PUM
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·February 22, 2012
TENACULUM FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·May 15, 2014
ATTAIN STARFIX
FDA Adverse Event
Injury
·MPRI·Product code OJX·October 31, 2012
HIGH FLOW TRAUMA TIP
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS PUERTO RICO·Product code FQH·August 11, 2010
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