10 results
·
23ms
·
Sources: EU EUDAMED, US FDA
NorthStar Mapping System
FDA 510(k)
FDA Class 2
·Cardiovascular
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704283761·HOOK SKIN RIGID 1 PRONG BLUNT 6.5"
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112984·CORNEAL TREPHINE BLADE9.5MM
S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A
FDA 510(k)
FDA Class 2
·Radiology
WALLACH ULTRA FREEZE
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code GEH·November 4, 2019
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 14, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 16, 2011
NEXGEN LPS PROLONG ARTICULAR SURFACE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·July 25, 2013
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