8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR
FDA 510(k)
FDA Class 1
·Ophthalmic
KATENA
FDA UDI
NURSE ASSIST, INC.·B150K870650·
GRAVITYTM PEEK-OPTIMA Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000
FDA 510(k)
FDA Class 2
·Microbiology
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 12, 2014
PIC 50
FDA Adverse Event
Malfunction
·WELCH ALLYN PROTOCOL, INC.·Product code MKJ·October 6, 2010
COATED VICRYL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·December 12, 2012
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024