15 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EASY TOUCH
FDA 510(k)
FDA Class 2
·General Hospital
REPICCI II RESURFACING KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304447844·
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112991·CORNEAL TREPHINE BLADE16MM
GEN4 Direct Access
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828101592·GEN4 Direct Access
Custom Healthcare Systems, Inc.
FDA UDI
Manus Medical, LLC·00811870035548·
Integra®
FDA UDI
INTEGRA PAIN MANAGEMENT·10381780260202·BIOPSY TRAY
FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW
FDA 510(k)
FDA Class 2
·Anesthesiology
MODIFICATION TO INTEL HEALTH GUIDE PHS6000
FDA 510(k)
FDA Class 2
·Cardiovascular
GALAXY G3 MINI 1MM X 4CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·March 10, 2022
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2013
2008K2 HEMODIALYSIS MACHINE
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA, CONCORD MANUFACTURING·Product code KDI·September 17, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 20, 2011
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024