10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GF85 (models GF85-3P, GF85-SP)
FDA 510(k)
FDA Class 2
·Radiology
LCP
FDA UDI
Synthes GmbH·10886982168504·2.4MM LCP® DISTAL RADIUS T-PLATE 3H HEAD/4H SHAFT
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113547·SLIT BLADE 3.2MM ANGLED (BX/5)
opti-Toe
FDA 510(k)
FDA Class 2
·Orthopedic
CAPSULE TENSION RING INSERTER, MODEL 7-810
FDA 510(k)
FDA Class 1
·Ophthalmic
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 2, 2025
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 10, 2011
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·November 11, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 23, 2013
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024