13 results
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18ms
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Sources: EU EUDAMED, US FDA
OXFORD EXTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Convaid
FDA UDI
CONVAID PRODUCTS, INC.·00840117408579·
Convaid
FDA UDI
CONVAID PRODUCTS, INC.·10840117400952·
ACUMED
FDA UDI
Acumed LLC·10806378040405·Uni. Tray Midshaft Fore Plate Insert Lid
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209102709·KIT, NAR-4 AID w' COMBAT GAUZE - DUC; This kit ...
SUPERION INDIRECT DECOMPRESSION SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NQO·March 5, 2021
DISTAL HUMERAL PLATES WITH ANGULAR STABILITY
FDA 510(k)
FDA Class 2
·Orthopedic
AUDIOSCREENER OAE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
UNKNOWN SLING
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS (MN)·Product code FTL·May 8, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·October 12, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 29, 2007
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022