9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SOL-CARE IV Bag Safety Connector
FDA 510(k)
FDA Class 2
·General Hospital
MEDYSSEY ANTERIOR CERVICAL FUSION CAGE
FDA 510(k)
FDA Class 2
·Orthopedic
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·November 14, 2008
11/13 S-ROM 44 MM M SPEC +6
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·August 18, 2011
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 18, 2013
MENTOR SILTEX ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·May 21, 2019
Bicarby Dialysate; Model number: RFP-400-G;
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KPO·May 7, 2026
Optiflux High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code FJI·August 29, 2025