11 results
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19ms
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Sources: EU EUDAMED, US FDA
DIMPLO Implant System
FDA 510(k)
FDA Class 2
·Dental
XiVE® TG
FDA UDI
Dentsply Implants Manufacturing GmbH·07392532223129·Transfer Impression Coping short
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575045259·Proximal Tibial Spacer,Size small
SBI K-WIRES
FDA 510(k)
FDA Class 2
·Orthopedic
Finessis Corium Flexylon Powder Free Sterile Green Surgical Gloves
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PurSwab
FDA UDI
Puritan Medical Products·00609576390074·Sterile Foam Tipped Applicators
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 30, 2024
FLOCARE INFINITY 2 PUMP
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code LZH·August 30, 2011
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·November 14, 2014
12/14 ARTICUL 40MM M SPEC+15.5
FDA Adverse Event
Injury
·8010379 DEPUY INTL., LTD.·Product code LPH·July 29, 2013
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024