10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Snowden-Pencer
FDA UDI
CAREFUSION 2200, INC·10885403150753·Snowden-Pencer Cardiovascular FORCEPS MICRO DEB...
Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
INFANT VENTILATOR MODEL 100
FDA 510(k)
FDA Class 2
·Anesthesiology
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·April 9, 2014
STERIS SYSTEM 1E
FDA Adverse Event
STERIS CORPORATION - HOPKINS·Product code MED·December 19, 2012
INFINTI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHOLOGY CENTER·Product code HQC·October 15, 2010
Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E c. Male-Female Midsection, 60mm, 1 EACH; Model Number: 25001060E d. Male-Female Midsection, 70mm, 1 EACH; Model Number: e. Male-Female Midsection, 90mm, 1 EACH; Model Number: 25001090E f. Male-Female Midsection, 110mm, 1 EACH; Model Number: 25001110E g. Male-Female Midsection, 140mm, 1 EACH. Model Number: 25001140E Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020