8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
HEMOGLOBINOMETER MODEL 720 B
FDA 510(k)
FDA Class 2
·Hematology
Brux Night Guard
FDA 510(k)
FDA Unclassified
·Unknown
CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX
FDA 510(k)
FDA Class 2
·General Hospital
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·April 30, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 10, 2012
PUMP MMT-722NAP PRDGM INS V2.2 PL EN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS, MED REL·Product code MDS·July 29, 2010
Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781361
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781361
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024