11 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MIRADRY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SLIM ONEBODY SYSTEM
FDA 510(k)
FDA Class 2
·Dental
SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·October 13, 2020
HALO PKS CUTTING FORCEPS
FDA Adverse Event
Malfunction
·GYRUS/ACMI·Product code GEI·May 22, 2013
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·June 16, 2011
POWERED WHEELCHAIR
FDA Adverse Event
INVACARE TAYLOR STREET·Product code ITI·October 1, 2014
MOZEC¿ RX PTCA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·September 20, 2022
MOZEC¿ RX PTCA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·September 20, 2022
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025