22 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EBA2 FEMORAL NAILING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
COE-FLEX®
FDA UDI
Gc America Inc.·10386040004831·COE-FLEX® Standard Package Regular Body, Fast S...
COE-FLEX®
FDA UDI
Gc America Inc.·D6581310051·COE-FLEX® Standard Package Regular Body, Fast S...
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564035707·L3 GOWN, PLR XX-LARGE W/TWL
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00810019800283·Gown, Surgical L3, XXL
Pro-Link Ti
FDA UDI
Life Spine, Inc.·00190837080860·
Pro-Fit
FDA UDI
PULMODYNE INC·00841470111250·
MIRABAY
FDA UDI
Mirabay Orthodontics Corp.·05061075029247·OPTIMAL SYMMETRY ARCHWIRE TRANS THERM PL W/STOP...
Trivicta
FDA UDI
Ortho Development Corporation·00822409123704·Collarless EXT Size 5
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180517918·ALIF, MODULAR DISTRACTOR, IMPACTION TIP, 5mm, S...
ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT
FDA 510(k)
FDA Class 2
·Dental
LUMEND FRONTRUNNER GW CTO CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197398572·Micro Curette
backwa...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 28, 2025
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962162743·MICROCECT CURETTE, BACKWARD ANGLE, #5
6IN AML LRG STATURE 12.0 MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. - 1818910·Product code LPH·October 1, 2014
CONSTELLATION
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LTD.·Product code HQC·April 12, 2013
ATTAIN ABILITY
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·June 16, 2011
Depuy P.F.C. E Knee System, stabilized plus tibial insert; polyethylene tibial insert, Sz 5, 15 mm; Ref 96-2752.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005
AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129; e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130; f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131; Orthopedic surgical instrument.
FDA Enforcement
Class II
·Terminated·Cayenne Medical Inc.·August 1, 2018