7 results
·
28ms
·
Sources: EU EUDAMED, US FDA
YD STRIP GPH U21
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HS-100 HEADSPACE SAMPLING ACCESSORY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MICRODAPT DENTAL RESTORATIVE BONDING
FDA 510(k)
FDA Class 2
·Dental
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 28, 2014
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·November 15, 2012
SELECTSECURE
FDA Adverse Event
Injury
·MPRI·Product code NVN·June 10, 2015
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024