11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Microbiology
ArgenIS
FDA UDI
ARGEN CORPORATION, THE·D818131605·MUA ZS RP 4.5GH Ang30
OsteoMed
FDA UDI
OSTEOMED LLC·00845694047685·Low Profile L Plate Right
MYLABONE ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 3, 2024
DXTEND SCREW LOCK D4.5X36MM
FDA Adverse Event
Injury
·DEPUY FRANCE SAS 3003895575·Product code HSD·October 1, 2014
HEARTSTART MRX-EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 17, 2013
RELIA DR
FDA Adverse Event
Malfunction
·MEDTRONIC S.A.·Product code NVZ·June 16, 2011
Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 3, 12.5 mm; Ref 97-0352.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code JWH·May 26, 2005
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024