19 results · 21ms · 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.

SECURE ARTERIAL BLOOD SAMPLING SYSTEM

FDA 510(k)
FDA Class 1 ·Anesthesiology

PILLING

FDA UDI
TELEFLEX INCORPORATED·24026704507393·

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306802171·Mixter Hemostatic Forceps, Strongly Curved, 14 cm

Tiche PTA Balloon Dilatation Catheter

FDA UDI
BrosMed Medical Co.,Ltd.·06958481475272·

HYSTALOG HSG CATHETER

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

LINEAR 3-6

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 25, 2021

PRECISION? MONTAGE? MRI

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 18, 2025

HYPERGLIDE

FDA Adverse Event
Malfunction ·COVIDIEN (IRVINE)·Product code MJN·March 29, 2017

HYPERGLIDE

FDA Adverse Event
Injury ·COVIDIEN (IRVINE)·Product code MJN·March 29, 2017

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 22, 2013

GE OEC 8800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 9, 2008

BASIC CONFIGURATION MODEL 6100 KNEE GATCH

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FPO·April 18, 2011

EQUINOXE SHOULDER COMPONENTS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWS·June 27, 2024

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022