34 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.

Hang&Go PAC

FDA 510(k)
FDA Class 2 ·General Hospital

OsteoMed

FDA UDI
OSTEOMED LLC·00842528102169·5.5 mm Cannulated Tap, Standard AO Quick Release

VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5)

FDA 510(k)
FDA Class 2 ·Hematology

XELIS FUSION

FDA 510(k)
FDA Class 2 ·Radiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 24, 2025

FROVA INTUBATING INTRODUCER

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code BTR·May 12, 2026

ENTRUST

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·October 10, 2014

FLEXTEND

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVN·July 14, 2011

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code PAH·June 11, 2013

ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026

Jackson-Pratt Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

FDA Enforcement
Class II ·Terminated·Cardinal Health 200, LLC·May 31, 2017

FROVA INTUBATING INTRODUCER

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code BTR·February 8, 2024

FROVA INTUBATING INTRODUCER

FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code BTR·January 3, 2020

FROVA INTUBATING INTRODUCER

FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code BTR·April 28, 2022

FROVA INTUBATING INTRODUCER

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code BTR·September 27, 2024

FROVA INTUBATING INTRODUCER

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code BTR·August 29, 2023

FROVA INTUBATING INTRODUCER

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code BTR·August 31, 2023

FROVA INTUBATING INTRODUCER

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code BTR·October 15, 2021

FROVA INTUBATING INTRODUCER

FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code BTR·May 1, 2020

FROVA INTUBATING INTRODUCER

FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code BTR·January 3, 2019