22 results · 31ms · Sources: EU EUDAMED, US FDA

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AIW WATER SYSTEM FOR HEMODIALYSIS

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

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·00304040001523·MaxiTemp HP Kit

artVeneer life

FDA UDI
Merz Dental GmbH·D7092001282·artVeneer life upper anteriors, ITM, B4

Vista

FDA UDI
Modus Medical Devices Inc·G34350012821·10 cm PET Jar & Lid - box of 60

PRO-TEC PIG

FDA UDI
BIODEX MEDICAL SYSTEMS, INC.·00718175000830·Pig, Pro-Tech, 3/6cc Blue

ClikStik CCD Complete Digital Holder Kit

FDA UDI
CLIKTECH LLC·00856200001282·ClikStik CCD Complete Digital Holder Kit

Rampart One Lumbar Interbody Fusion System

FDA UDI
SPINEOLOGY INC.·M7401001282·Rampart One Implant Tray

T.W. POWER SUPPLY

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code GEI·November 22, 2024

STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100

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

MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1

FDA 510(k)
FDA Class 2 ·Cardiovascular

TSRH® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWP·April 19, 2013

TSRH SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC ORTHOPEDIC INC.·Product code KWP·December 4, 2009

TSRH SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·December 4, 2009

TSRH SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·May 29, 2013

IMPAX CV REPORTING

FDA Adverse Event
Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·February 26, 2013

SYNCHRON® LX WASH SOLUTION

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code JJE·February 24, 2011

CARDIOBLATE GEMINI

FDA Adverse Event
Malfunction ·MEDTRONIC CARDIAC SURGERY TECHNOLOGIES·Product code GEI·February 15, 2008

TSRH SPINAL SYSTEM

FDA Adverse Event
WARSAW ORTHOPEDIC, INC.·Product code KWP·August 26, 2011

ADULT INSPIRATORY HEATED BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·September 15, 2011

ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014