14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BONEMEDIK-DM
FDA 510(k)
FDA Class 2
·Dental
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014607412·SKYTRON 3600 4" SOFTCARE
OMEGA II SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 5, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 7, 2025
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code DQX·December 17, 2024
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 26, 2013
MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code MAF·May 6, 2011
ANEURX AAADVANTAGE STENT GRAFT DELIVERY SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·July 23, 2008
Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)
FDA Enforcement
Class II
·Terminated·Kinsman Enterprises Inc·October 27, 2021
AS COLUMBUS REV F FEMUR ZEMENTIERT F5L
FDA Adverse Event
Injury
·AESCULAP AG·Product code JWH·November 6, 2019
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018