11 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
NC Screw-retained Abutment
FDA UDI
BIO CONCEPT Co., Ltd.·06947600381105·
3-LD TWIN ECG CABLE, 90 DEG, A
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828145640·3-LD TWIN ECG CABLE, 90 DEG, A
3-LD DIN ECG CABLE,90 DEG, A
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828145626·3-LD DIN ECG CABLE,90 DEG, A
CYNOSURE YAG FAMILY LASER (PHOTOGENICA YAG AND ACCLAIM)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE
FDA 510(k)
FDA Class 2
·Anesthesiology
INGENIO
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014
SD - PEEK SMALL SPACER - 9MM X 22MM X 10MM (PEEK)
FDA Adverse Event
Malfunction
·ALPHATEC SPINE INC·Product code MQP·May 29, 2013
CONCERTO II CRT-D
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NIK·June 16, 2011
VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
FDA Enforcement
Class II
·Terminated·Civco Medical Instruments Co. Inc.·December 29, 2021
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