15 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AXOSTIM NERVE STIMULATOR, MODIFICATION
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LEG POSITIONER
FDA UDI
Biomet Orthopedics, LLC·00880304406353·
Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746100208·DB BKT MASTER UR CUSP 018 T=0 A+7 R=0
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482129777·Symmetry® Sleeve; Reducer; 10 mm
Arthrex®
FDA UDI
ARTHREX, INC.·00888867316799·LOW PROFILE CORTICAL SCW, TI, 5.0x35MM
STAR TOTAL ANKLE REPLACEMENT
FDA Adverse Event
Injury
·SMALL BONE INNOVATIONS, INC.·Product code NTG·February 11, 2014
NexGen® Complete Knee Solution
FDA UDI
Zimmer, Inc.·00889024202337·
FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WILSON-COOK COLON DECOMPRESSION SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TANDEM T: SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·May 27, 2014
TENDRIL STS
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 9, 2013
RADIAL JAW 4 BIOPSY FORCEPS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA·Product code FCL·November 22, 2010
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024