28 results · 23ms · Sources: EU EUDAMED, US FDA

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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