12 results
·
27ms
·
Sources: EU EUDAMED, US FDA
VZV IGG ELISA TEST
FDA 510(k)
FDA Class 2
·Microbiology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122994·K-WIRE - SINGLE TROCAR 1.4mm DIA x 150mm
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150713·K-WIRE - SINGLE TROCAR 1.0mm DIA x 100mm
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150737·K-WIRE - SINGLE TROCAR 1.0mm DIA x 150mm
MIDI-SRS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MAXIM ACCEL (VANGUARD) PS+ BEARINGS
FDA 510(k)
FDA Class 2
·Orthopedic
MALLINCKRODT
FDA Adverse Event
Malfunction
·COVIDIEN·Product code BTR·August 17, 2016
CUSTOM EPIDURAL ANESTHESIA TRAY
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL, INC.·Product code BSO·April 24, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS·Product code JAA·January 31, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·December 22, 2010
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025