29 results · 22ms · Sources: EU EUDAMED, US FDA

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PSN HEMODIALYZER, MODELS PSN 170, PSN 210

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Custom Procedure Kit

FDA UDI
MEDIVATORS INC.·40677964012608·The ENDO CARRY-ON Procedure Kit contains all of...

Capstone Control PTC Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169679788·SPACER 5001422 CONTROL PTC 6 DEG 14X22

CAPSTONE CONTROL™ Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169109810·SPACER 4001422 6 DEG 14X22

Premier Total Etch

FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783000849·PREMIER TOTAL ETCH GEL 12gm

ADVANCE®

FDA UDI
Microport Orthopedics Inc.·M684K00141221·

artVeneer life

FDA UDI
Merz Dental GmbH·D7092001422·artVeneer life lower anteriors, UBS, C4

S57D DIGITAL OPERATING ROOM CAMERA

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061

FDA 510(k)
FDA Class 2 ·Immunology

DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code PQF·May 12, 2018

CS100

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·August 26, 2014

CS300

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·July 30, 2013

CS300

FDA Adverse Event
Death ·DATASCOPE MAHWAH·Product code DSP·November 10, 2015

CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

FDA Adverse Event
Malfunction ·DATASCOPE CORP. - MAHWAH·Product code DSP·July 21, 2022

CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

FDA Adverse Event
Malfunction ·DATASCOPE CORP. - MAHWAH·Product code DSP·January 23, 2023

CS300

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·July 2, 2014

CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

FDA Adverse Event
Malfunction ·DATASCOPE CORP. - MAHWAH·Product code DSP·June 22, 2023

CS100

FDA Adverse Event
Malfunction ·DATASCOPE CORP·Product code DSP·June 6, 2014

iBOT PMD with software version 01.05.24. Personal Mobility Device.

FDA Enforcement
Class II ·Ongoing·Mobius Mobility LLC·June 18, 2025

CS300

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·July 29, 2014