29 results
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22ms
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Sources: EU EUDAMED, US FDA
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