28 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Rotium Bioresorbable Wick
FDA 510(k)
FDA Class 2
·Orthopedic
24M - Duke Energy FA/BBP
FDA UDI
Certified Safety Manufacturing, Inc.·00766588015149·24M - Duke Energy FA/BBP
UP - Vehicle - 380-55230 - 18 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588014173·UP - Vehicle - 380-55230 - 18 Metal
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327512922·Y-PLATE, CURVED, MP, LEFT
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383556354·"An absorbent paper points is an endodontic pap...
KWIKKMODEL
FDA 510(k)
FDA Class 2
·Dental
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467
FDA 510(k)
FDA Class 1
·Clinical Toxicology
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·January 12, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·January 12, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·January 21, 2022
CODMAN VPV SYSTEM
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF, INC·Product code JXG·November 3, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 27, 2014
ORTHO PROVUE
FDA Adverse Event
Malfunction
·MICROTYPING SYSTEMS·Product code KSZ·August 11, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 26, 2013
BD PHASEAL¿ PROTECTOR P13-O
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·April 6, 2023
BD PHASEAL¿ OPTIMA PROTECTOR (P13-O)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·February 14, 2023
BD PHASEAL OPTIMA PROTECTOR (P13-O)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·February 22, 2023
MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No. 01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.
FDA Enforcement
Class I
·Terminated·Teleflex Medical·February 18, 2015
GE Inspection Technologies Blade|line Industrial Cabinet X-ray system
FDA Enforcement
Class II
·Terminated·GE Inspection Technologies, LP·August 9, 2017
HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy.
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·July 31, 2013