7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
BAXTER BEDSIDE SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
ACTH RIA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
H.R. JAKOBI SURG. INSTRUMENTS #11 16/46
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 16, 2014
PUMP MMT-722NAS PRDGM INS V2.2 SK EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·October 14, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·December 14, 2012
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024