18 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
INNOVASIS CRANIAL SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)
FDA 510(k)
FDA Class 2
·Cardiovascular
QUANTA FLASH H-TTG IGG
FDA 510(k)
FDA Class 2
·Immunology
Zavation
FDA UDI
Zavation LLC·00842166123038·Cage - 14x16mm, 44-76mm, 15°
Zavation
FDA UDI
Zavation LLC·00842166123021·Cage - 14x16mm, 44-76mm, 10°
Zavation
FDA UDI
Zavation LLC·00842166123014·Cage - 14x16mm, 44-76mm, 5°
Zavation
FDA UDI
Zavation LLC·00842166123007·Cage - 14x16mm, 44-76mm, 0°
SEDLINE KIT
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code MWI·December 7, 2017
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929035191·Corpectomy, 14Dx16Wx44H 6°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929065242·Corpectomy, 14Dx16Wx44H 0°
SEDLINE KIT
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code MWI·January 8, 2017
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 12 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 26, 2016
SEDLINE KIT
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code GWQ·July 21, 2017
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 27, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 3, 2008
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026