15 results
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19ms
·
Sources: EU EUDAMED, US FDA
PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE
FDA 510(k)
FDA Class 2
·Dental
ITOTAL IDENTITY MEDIUM KEEL PUNCH
FDA UDI
Conformis, Inc.·00810933030667·
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014605166·MAQUET/SIEMENS 1130 4" SOFTCARE
Bioseal Inc.
FDA UDI
BIOSEAL·00630094298023·Vaginal Speculum Clear Small, Light Source
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450180594·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450180389·
Track B
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR4080220·Track B ø 2,0 x 125 mm
XTRACTOR, MODEL M143
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MA-300 ELECTROMYOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 31, 2025
ICON 25HCG
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JHI·February 14, 2011
PROMOTE ACCEL CRT-D
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·April 26, 2013
PUMP MMT-712LNAP PRDGM INS PL EN US LN
FDA Adverse Event
MEDTRONIC MINIMED·Product code LZG·July 18, 2008
HS III PROXIMAL SEAL SYSTEM 3.8MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC.·Product code DXC·April 7, 2011
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