12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSSEOSPEED TM PROFILE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014604725·LATERAL POSITIONER PAD W/VELCRO 8.5 x 6 x 2
NA
FDA UDI
STRYKER CORPORATION·07613327052329·Trocar, Pyramidal Tip
SMART SHIELD NON-STERILE POWDER-FREE PEPPERMINT SCENTED GREEN LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
SLEEP PAT 200 DEVICE
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 29, 2026
CADD MEDICATION CASSETTE
FDA Adverse Event
Malfunction
·NULL·Product code FPA·February 4, 2022
ECHO POR FMRL NC 9X125MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·January 18, 2022
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·April 6, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 17, 2008
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