14 results
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34ms
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Sources: EU EUDAMED, US FDA
BOMED-NCCOM
FDA 510(k)
FDA Class 2
·Cardiovascular
Bioplate®
FDA UDI
Bioplate, Inc.·M3848130200·Straight Plate - Ø1.9 mm - 2 hole - 15 mm
MediByte Electrode Prep Kit
FDA UDI
Braebon Medical Corporation·B1408130201·Consumables to be used with the MediByte. The s...
MATIRA ANTERIOR CERVICAL SYSTEM
FDA UDI
Kalitec Direct LLC·B07307K0130201·PLATE CALIPER
Bioplate®
FDA UDI
Bioplate, Inc.·M384813020CP1·Straight Plate - Ø1.9 mm - 2 hole - 15 mm
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197322027·Jurasz laryngeal polypus forceps Fig. 2
220mm,...
Bioplate®
FDA UDI
Bioplate, Inc.·M384813020US0·Straight Plate - Ø1.9 mm - 2 hole - 15 mm
TREU
FDA UDI
TREU-Instrumente GmbH·04048447299478·Dynamic Screw 3,2mm/100mm/30mm Thread BrainLAB ...
IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS
FDA 510(k)
FDA Class 2
·Immunology
Endosee System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 15, 2014
MAXIMO II VR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·October 31, 2012
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
FDA Adverse Event
Malfunction
·STAAR SURGICAL CO.·Product code HQL·August 12, 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