13 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201502549·MR-Adapter Philips 3T QHC T/R
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690110736·Patella Trial 32mm x 8mm
OMNI Knee
FDA UDI
Omni Life Science, Inc.·00841690101956·All Poly 3 Peg Patella 32 mm x 8 mm
MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
MULTIPLE (IZON DNA BLOOD COLLECTION KIT)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 14, 2026
GENESIS PULSE GENERATOR, 8-CHANNEL
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·February 15, 2011
INVACARE POWER WHEELCHAIR
FDA Adverse Event
Injury
·INVACARE CORP. - MANUFACTURING FACILITY·Product code ITI·October 2, 2007
STERILIZABLE RUBBER CAP
FDA Adverse Event
Injury
·CARL ZEISS (OPHTHALMIC)·Product code EPT·May 7, 2008
TRUSHOT WITH Y-KNOT 1.8MM ALL-SUTURE ANCHOR
FDA Adverse Event
Injury
·CONMED LARGO·Product code MBI·May 8, 2024
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018