24 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.

MULTI-LEAD TRIALING CABLE MODEL 355531

FDA 510(k)
FDA Class 2 ·Neurology

Oxygen Sensor

FDA UDI
Honeywell Healthcare Solutions GmbH·04036616010788·

Carbide burs

FDA UDI
DFS - DIAMON GmbH·04057176163851·Carbide 2 CA 2,3 mm

Oticon

FDA UDI
Oticon A/S·05707131189615·K210, ITC P L BE

Knolle Irrigating Cannula, 23ga

FDA UDI
KATALYST SURGICAL LLC·00840096205398·Knolle Irrigating Cannula, 23ga

GUTTA PERCHA POINTS

FDA UDI
DiaDent Group International·08806383502511·Gutta Percha Points is used to root canal filin...

ADVANTAGE DRIVE SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·Product code FOZ·June 25, 2021

TERUMO ADVANCED PERFUSION SYSTEM 1

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·May 2, 2013

TERUMO PERFUSION SYSTEM 8000

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code JOR·May 20, 2011

SIPHONGUARD, CSF FLUID CONTROL DEVICE

FDA Adverse Event
Injury ·CODMAN & SHURLTEFF, INC/MEDOS S.A.·Product code JXG·August 8, 2008

ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open, laparoscopic , and endoscopic surgeries Model/Catalog Number: WA91307C

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·July 31, 2024

Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021