13 results · 30ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer

FDA 510(k)
FDA Unclassified ·Unknown

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114254·CHAMBER MAINTAINER 25GA (PK/10)

CastleLoc-P Anterior Cervical Plate System

FDA 510(k)
FDA Class 2 ·Orthopedic

R2-MRI ANALYSIS SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

BD LOGIC BLOOD GLUCOSE MONITOR

FDA Adverse Event
Other ·BECTON DICKINSON·Product code NBW·August 28, 2006

SYRINGE 30ML LL S/C 56

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·April 2, 2025

SL 1 INTRODUCER UNK

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, AF DIVISION·Product code DYB·March 10, 2011

RESPONSE EP CATHETER UNK

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, AF DIVISION·Product code DRF·March 10, 2011

TRANSSEPTAL NEEDLE, BRK SERIES

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, AF DIVISION·Product code DRC·March 10, 2011

WEDGE TURNING FRAME

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FPO·September 1, 2011

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·November 11, 2014

GYNECARE TVT RETROPUBIC SYSTEM

FDA Adverse Event
Injury ·ETHICON INC.·Product code FTL·July 23, 2013

PKG, MICRO SCISSORS, STRAIGHT, P/N 0250080269. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

FDA Enforcement
Class II ·Terminated·Stryker Endoscopy·December 24, 2014