16 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES (USA) MODULAR BLADE PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014604565·NARROW HEADREST PAD 2", 20 X 16 X 2
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450179185·
General Instrument
FDA UDI
ALPHATEC SPINE, INC.·00840180506707·Longer Rotating Distractor, Holed, 9mm
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101090·Distractor, Smooth Paddle, Lordotic, 9mm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0101090·Distractor, Smooth Paddle, 9mm
SCREW
FDA Adverse Event
Malfunction
·NOBEL BIOCARE AB·Product code NHA·August 29, 2023
SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
FDA 510(k)
FDA Class 2
·Hematology
FLUOROPERM 151-OK, PARAGON HDS 100-OK
FDA 510(k)
FDA Class 2
·Ophthalmic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 5, 2024
INFINION? CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 29, 2025
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·April 26, 2013
IAB : 8 FR - 40 CC
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code DSP·April 7, 2011
GLOBAL ANCHOR PEG GLENOID 44MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWS·July 18, 2008
SMARTSET MV 40G - EO
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LOD·November 28, 2018
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