25 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Meticuly Patient-Specific Titanium Mesh Implant
FDA 510(k)
FDA Class 2
·Neurology
NA
FDA UDI
MAKO SURGICAL CORP.·00848486031893·SHORT ANTLER
ExploR®
FDA UDI
Biomet Orthopedics, LLC·00880304210493·
Dilator, Vascular, Memory 24cm 5.0mm monobloc
FDA UDI
Geister Medizintechnik GmbH·04057034046357·Dilator, Vascular, Memory
24cm 5...
PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULTIFOCAL XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULT
FDA 510(k)
FDA Class 2
·Ophthalmic
ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·June 16, 2022
UNKNOWN STEM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·January 16, 2020
UNKNOWN HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·January 16, 2020
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 29, 2014
EDGE INSUL. COATED BLADE
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GEI·June 27, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·August 3, 2011
EXPLOR 12X22MM IMPLANT HEAD
FDA Adverse Event
Injury
·Product code JDB·August 18, 2021
INJECTOR LOCKING N40-O
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·September 15, 2021
EXPLOR 12X22MM IMPLANT HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWI·February 23, 2021
Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.
FDA Enforcement
Class II
·Terminated·Churchill Medical Systems, Inc.·March 13, 2013
BD PHASEAL OPTIMA INJECTOR (N40-O)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·September 14, 2021
Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
FDA Enforcement
Class I
·Ongoing·Busse Hospital Disposables, Inc.·January 10, 2024
EXPLOR 9X30MM IMPL STEM W/SCR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWI·May 18, 2022
EXPLOR MODULAR RADIAL STEM WITH SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWI·June 17, 2024