11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
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
SERIES A PAT W/WR THN 28 1 PEG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·January 12, 2022
SWEET PICOTIP
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 8, 2013
ITREL 3
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LGW·March 22, 2011
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
UNKNOWN·Product code IKX·August 27, 2014
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDS·March 10, 2016
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDS·March 10, 2016
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
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