13 results · 24ms · Sources: EU EUDAMED, 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