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