11 results
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26ms
·
Sources: EU EUDAMED, US FDA
KINDERWRAP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GC Initial™
FDA UDI
Gc America Inc.·15400556709136·GC Initial™ PC Pellets Dentin A3, 5pcs. X 2
GC Initial™
FDA UDI
Gc America Inc.·J0228720031·GC Initial™ PC Pellets Dentin A3, 5pcs. X 2
Oph. Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668121788·Thrifty Desmarres Lid Retractor, 12mm
HUMAN REFERENCE SERUM C4 COMPLEMENT
FDA 510(k)
FDA Class 2
·Immunology
BAND AID* ADHESIVE BANDAGES
FDA 510(k)
FDA Class 1
·General Hospital
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 13, 2014
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 17, 2010
MESH - COMPOSIX KUGEL
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·December 6, 2012
SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021