28 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
10PW - General Purpose
FDA UDI
Certified Safety Manufacturing, Inc.·00766588020129·10PW - General Purpose
Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IDB 2
FDA UDI
Sprintray, Inc.·00850039704055·Indicated for the fabrication, by additive manu...
SuperCable® Grip and Plate System
FDA UDI
Kinamed, Inc.·00818720010083·Cable-Plate, 8-Hole, Curved
SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
SYNTHES LOW PROFILE NEURO SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Ultrakleen KSponge II Spears Catalog #: K20-5012
FDA Recall
Terminated
·Ultracell Medical Technologies·Product code HOZ·January 8, 2003
OPTISENSE
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·January 13, 2014
LIFELINE AED
FDA Adverse Event
Malfunction
·DEFIBTECH, LLC·Product code MKJ·June 27, 2013
UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM
FDA Adverse Event
Injury
·BECKMAN COULTER, INC.·Product code JGS·August 5, 2011
Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
FDA Enforcement
Class II
·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013
Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
FDA Recall
Terminated
·Surgical Instrument Service And Savings, Inc.·Product code HRH·May 3, 2013
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·March 25, 2022
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
PEN NDL 32GA 4MM 100 BX 1200 CA
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·November 12, 2020
PEN NDL 31GA 8MM 100 BX 1200 USA
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·December 30, 2020
SCREW FIXATION BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·February 2, 2015
IMPLANT FIXATION DEVICE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDP·February 3, 2015
SCREW FIXATION BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·February 2, 2015
IMPLANT FIXATION DEVICE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDP·February 2, 2015