15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114285·LACRIMAL CAN TAPPERED 19/23GA
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114254·CHAMBER MAINTAINER 25GA (PK/10)
LACTOSORB RAPIDFLAP
FDA 510(k)
FDA Class 2
·Dental
ONLINE DAT II COCAINE II
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LOGICAL STOPCOCK SET
FDA Adverse Event
Malfunction
·SMITH MEDICAL, ASD.·Product code DRS·October 14, 2008
ASKU
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·August 11, 2011
CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·July 2, 2013
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·November 18, 2022
ANTI-A (MURINE MONOCLONAL) SERIES 1
FDA Adverse Event
Malfunction
·IMMUCOR·Product code KSZ·February 10, 2010
TRUE METRIX
FDA Adverse Event
Injury
·TRIVIDIA HEALTH INC·Product code NBW·October 19, 2023
Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024