11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACE 3.5MM CORTICAL BONE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
Surgimedics®
FDA UDI
COASTAL LIFE TECHNOLOGIES, INC.·00814716020579·Smoke Evacuation Tubing
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482129784·Symmetry® Needle; Puncture; 5 mm Diameter; 10 G...
Arthrex®
FDA UDI
ARTHREX, INC.·00888867316928·LOW PROFILE CORTICAL SCW, TI, 5.0x48MM
SHILEY PHONATION VALVE
FDA 510(k)
FDA Class 2
·Anesthesiology
HYPERTHERMIA SENSOR ACCESSORIES
FDA 510(k)
FDA Class 2
·General Hospital
TANDEM T: SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·May 27, 2014
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·January 9, 2013
VANGUARD PS OPEN BOX FEMORAL 60 MM RIGHT-INTERLOK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·November 22, 2010
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