33 results · 24ms · Sources: EU EUDAMED, US FDA

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OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1

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

Bur PM2-70 80K FC Ø6.0 St

FDA UDI
Bien-Air Surgery SA·17630055517064·

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814541·GENUMEDI SAND SIZE III

Endo Carry-On Procedure Kit

FDA UDI
MEDIVATORS INC.·00677964053597·Endo Carry-on Procedure Kit includes Transport ...

Biliary Drainage Tube

FDA UDI
OLYMPUS MEDICAL SYSTEMS CORP.·04953170046353·

N/A

FDA UDI
Doppkon GmbH & Co. KG·04262494463761·Blakesley Biopsy Grasping Forceps D 4.0mm, WL 1...

POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR

FDA 510(k)
FDA Class 1 ·General Hospital

ESTHETICA

FDA 510(k)
FDA Class 2 ·Dental

Widex

FDA UDI
Widex A/S·05706069720341·Widex D-FA P (Warm beige S-330 ) Telecoil, Volu...

Navigation Instruments

FDA UDI
VB Spine LLC·10888857379343·Awl Tap Size Ø7.5 mm SERENGETI

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
JUMAO MEDICAL EQUIPMENT·Product code IOR·May 8, 2013

SHILEY LOW PRESSURE CUFFED

FDA Adverse Event
Injury ·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code JOH·May 19, 2011

EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code KRH·August 6, 2008

ITREL II

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code LGW·May 19, 2014

'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805

FDA Recall
Open, Classified ·New Standard Device Inc·Product code KTT·July 23, 2019

'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805

FDA Enforcement
Class II ·Ongoing·New Standard Device Inc·June 21, 2023

Sanarus Visica Treatment System (disposable), Model/Product Code: VP-0500 (single)

FDA Recall
Terminated ·Sanarus Medical Inc·June 16, 2003

CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

FDA Enforcement
Class II ·Terminated·CME America, LLC·December 9, 2020

Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018

TherMax Blood Warmer Unit

FDA Enforcement
Class II ·Terminated·Baxter Healthcare Corporation·November 6, 2019