12 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE)
FDA 510(k)
FDA Class 2
·Cardiovascular
WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500
FDA 510(k)
FDA Class 2
·Cardiovascular
AESCULAP SURGICAL INSTRUMENTS
FDA Adverse Event
Injury
·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·November 27, 2019
AESCULAP SURGICAL INSTRUMENTS
FDA Adverse Event
Injury
·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·November 27, 2019
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929065273·Corpectomy, 14Dx16Wx47H 0°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929065600·Corpectomy, 14Dx16Wx47H 6°
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA·Product code DQX·June 27, 2011
UNKNOWN
FDA Adverse Event
Malfunction
·UNKNOWN·Product code LNH·August 28, 2008
Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10
FDA Enforcement
Class II
·Terminated·Vivorte, Inc.·July 14, 2021
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026