11 results · 31ms · Sources: EU EUDAMED, 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