94 results · 23ms · Sources: EU EUDAMED, US FDA

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Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·saypha® ChiQ™

Sonosite PX Stand

FDA UDI
FUJIFILM SONOSITE, INC.·00841517105914·

Sonosite PX Stand

FDA UDI
FUJIFILM SONOSITE, INC.·00841517106041·

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

FDA UDI
FX SOLUTIONS·03701037309285·HAND REAMER Ø10mm

Sonosite PX Stand Head

FDA UDI
FUJIFILM SONOSITE, INC.·00841517109981·DIAGNOSTIC ULTRAOSUND SYSTEM ACCESSORY

Sonosite PX Stand Head

FDA UDI
FUJIFILM SONOSITE, INC.·00841517110697·Diagnostic ultrasound system

Sonosite PX Stand Head

FDA UDI
FUJIFILM SONOSITE, INC.·00841517105907·

Sonosite PX Stand Head

FDA UDI
FUJIFILM SONOSITE, INC.·00841517106331·Sonosite PX Stand Head

Sonosite PX Stand Head

FDA UDI
FUJIFILM SONOSITE, INC.·00841517110703·Diagnostic ultrasound system

SPACELABS HEALTHCARE

FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522122705·10 LD PNT CBL PINCH CC/VOYAGER

Spacelabs Healthcare

FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522126079·10 LD PNT CBL PINCH CC/VOYAGER

Rotium

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

HEMODIALYSIS BLOODLINES

FDA Adverse Event
Malfunction ·B. BRAUN MEDICAL INC.·Product code FJK·October 22, 2025

VALKYRIE® - POWER DRIVER

FDA Adverse Event
Malfunction ·JEIL MEDICAL CORPORATION·Product code KIJ·January 22, 2026

Apex Lifts

FDA UDI
JOERNS HEALTHCARE, LLC·00810055881086·C-HLA-2 W/MESH LG U-SLING W/O HD SUPPORT

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval
FDA Class 3 ·CERALAS I LASER

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM

VALKYRIE® - POWER DRIVER

FDA Adverse Event
Malfunction ·JEIL MEDICAL CORPORATION·Product code KIJ·January 29, 2026

Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS

FDA Enforcement
Class II ·Ongoing·Covidien, LP·April 10, 2024

ONYX

FDA Adverse Event
Injury ·COVIDIEN (IRVINE)·Product code MFE·April 24, 2017