17 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772813834·GENUMEDI PRO SILVER SIZE III
JOBST UltraSheer
FDA UDI
BSN MEDICAL, INC.·00035664007324·ULTRA SHEER 20-30 MM HG WAIST HIGH MEDIUM WHITE...
Vatech Clismile
FDA UDI
Rayence Co., Ltd.·08800018601211·This product is an orthodontic bracket and is u...
Drive
FDA UDI
Drive Devilbiss Healthcare·00822383729107·GrabBar,Chrome,24",Knurled,3/cs,RTL
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970386·
INFINION 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 18, 2021
ILT TORQUER, MODEL 114TR1
FDA 510(k)
FDA Class 2
·Cardiovascular
FUJINON ULTRASONIC PROCESSOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·August 14, 2023
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
Malfunction
·UNKNOWN·Product code BTI·May 20, 2013
UNKNOWN DEPUY ASR 52 CUP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 1, 2011
IN TOUCH ZX
FDA Adverse Event
Malfunction
·STRYKER MEDICAL QUEBEC, LP·Product code FNL·August 16, 2008
22 G X 1.00 IN. (0.9 MM X 25 MM) BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Injury
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 29, 2017
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·January 1, 2025
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018