13 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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Arsenal Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
K152468
FDA UDI
Shenzhen Vistar Medical Supplies Co.,Ltd.·96973521874184·Reusable NIBP cuff,Thigh,single tube, HP connector
INFINITY CNAP SMARTPOD
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO: ORLUS MINI SCREW
FDA 510(k)
FDA Class 2
·Dental
BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231536 and 231539¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
PRECISION®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 8, 2014
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 8, 2013
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DRY·June 17, 2011
ELAN 4 MIS SLEEVE F/1-RING HANDPIECES
FDA Adverse Event
Injury
·AESCULAP AG·Product code HBC·October 28, 2018
ELAN 4 ELECTRO MOTOR CABLE W/HAND SWITCHHIGH SPEED POWER SYSTEMS
FDA Adverse Event
Malfunction
·AESCULAP AG·Product code HBC·November 5, 2018
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017