13 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PULMODYNE CHF FLOW GENERATOR SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5820802560·RETRACTOR, ALL TYPES
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014605364·MAQUET 1130 SPLIT LEG 2.25" DELUXE GEL
ADARA
FDA UDI
HNM TOTAL RECON LLC·00841742102887·ADARA ø4.5mm Cortical Screw, Full Thread, SS - ...
QUICK COMBO PAD
FDA Adverse Event
Injury
·PHYSIO CONTROL CORP.·Product code MLN·January 17, 1997
CAP PORP, CAP TORP
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ULTRAVUE/P 2000T, ULTRAVUE/C 2000T (HIOXIFILCON B) SOFT (MULTIFOCAL TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBIL
FDA 510(k)
FDA Class 2
·Ophthalmic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 7, 2025
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013
ACCU-CHEK FLEXLINK PLUS
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code FRN·April 6, 2011
UNK
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MHY·July 22, 2008
HANDLE CEV102910R DIA 10MM ANG W/RATCHET [MXI/XOM]
FDA Adverse Event
Injury
·XOMED MICROFRANCE MFG·Product code GCJ·December 20, 2013
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014