378 results
·
31ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
IPL sapphire ice cooling hair remove device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074362298·SCREW 7221635 HA COATED CANN 6.5 X 35
BD BBL™ CTA Medium™ with Lactose
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902216354·Tube Cta Medium With Lactose 10 Ea
KARATS MULTIPURPOSE SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
MouthLab Vital Signs Monitoring System
FDA 510(k)
FDA Class 2
·Cardiovascular
Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number: Dimension¿ EXL 200 00630414593579; Dimension¿ EXL with LM 00630414593500; Dimension¿ EXL with LM with STM 00630414593593; Dimension¿ RxL Max 00630414949789; Dimension¿ RxL Max HM 00630414949796; Dimension¿ RxL Max HM STM 00630414949819; Dimension¿ Xpand¿ Plus 00630414949833; Dimension¿ Xpand¿ Plus HM 00630414949840; Dimension¿ RxL Max Refurbished 00630414592947; Dimension¿ RxL Max HM Refurbished 00630414592954; Dimension¿ Xpand¿ Plus Refurbished 00630414592961; Dimension¿ Xpand¿ Plus HM Refurbished 00630414592978; Dimension¿ EXL with LM Refurbished 00630414000268; Dimension¿ 200 Refurbished 00630414010717;; Dimension¿ RxL Max w/o HM International 00630414949802; Dimension¿ RxL Max HM International 00630414945477; Dimension¿ RxL Max HM STM International 00630414949826; Dimension¿ Xpand Plus w/o HM International 00630414949857; Dimension¿ Xpand Plus w/HM International 00630414945484; Dimension¿ EXL with LM International 00842768030024; Dimension¿ EXL 200 International 00842768037214 Dimension¿ EXL with LM with STM International 00630414593609 The Dimension motor assembly is used in the Dimension Thermal Chamber Fan (ASSY BLOWER SNOUT) and is responsible for the intake and circulation of air inside the "Wok," a chamber within the Dimension instrument which enables greater temperature control of the testing environment.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·November 14, 2018
ACRYSOF RESTOR
FDA Adverse Event
Other
·ALCON RESEARCH LTD/HUNTINGTON·Product code MFK·November 5, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 11, 2013
CAPTURE-R READY-SCREEN (3)
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·June 8, 2016
CAPTURE-R READY-SCREEN (3)
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·June 8, 2016
3T HEATER/COOLER
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·March 19, 2026
HEATER-COOLER SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·October 1, 2025
HEATER-COOLER SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·April 30, 2026
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·October 10, 2025
HEATER COOLER 3T SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·December 3, 2025
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·October 10, 2025
HEATER COOLER 3T SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTQ·April 22, 2026
HEATER COOLER 3T SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUSTCHLAND·Product code DWC·April 7, 2026
HEATER-COOLER 3T SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·March 26, 2026