16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENVITEC REUSABLE SOFTIP Y SPO2 SENSORS
FDA 510(k)
FDA Class 2
·Cardiovascular
Tiche PTA Balloon Dilatation Catheter
FDA UDI
BrosMed Medical Co.,Ltd.·06958481476347·
ENSIL FABRIC
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MANUAL DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-502
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 13, 2025
INTELLIVUE MULTI MEASUREMENT SERVER X2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·March 28, 2013
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code KWP·June 13, 2008
MBT CEM KEEL TIB TRAY SZ5
FDA Adverse Event
Injury
·DEPUY (IRELAND)·Product code NJL·April 6, 2011
BD MULTITEST¿ 6-COLOR TBNK REAGENT W/BD TRUCOUNT¿ TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 20, 2022
BD MULTITEST¿ 6-COLOR TBNK
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·January 31, 2024
BD MULTITEST¿ 6-COLOR TBNK
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·January 31, 2024
O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
FDA Enforcement
Class II
·Terminated·Arjo Hospital Equipment AB·October 15, 2014
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022