15 results · 20ms · Sources: EU EUDAMED, US FDA

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FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776182106·BRUNS CURETTE ANG OVAL SIZE

Integra® Jarit®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780372318·Integra® Jarit® Bruns Oval Cup Curette, Angled,...

K-Systems

FDA UDI
Coopersurgical, Inc.·00888937025026·R65 Trolley

Trial BiPolar Head 22-42

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215072674·

CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON)

FDA 510(k)
FDA Class 2 ·Orthopedic

ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE

FDA 510(k)
FDA Class 2 ·Radiology

IMPLANT, ENDOSSEOUS, ROOT-FORM

FDA Adverse Event
Injury ·J DENTAL CARE SRL·Product code DZE·August 28, 2025

TANDEM T: SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·November 4, 2014

TENDRIL ST

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011

INCEPTA

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 22, 2013

Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A

FDA Enforcement
Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S

FDA Adverse Event
Malfunction ·AOMORI OLYMPUS CO., LTD.·Product code GEI·January 11, 2023

THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S

FDA Adverse Event
Malfunction ·AOMORI OLYMPUS CO., LTD.·Product code GEI·January 11, 2023

Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A

FDA Recall
Open, Classified ·CooperSurgical, Inc.·Product code PUB·November 15, 2024