19 results · 22ms · Sources: EU EUDAMED, US FDA

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EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

PowerPICC

FDA UDI
Bard Access Systems, Inc.·00801741188039·Catheter Placement Kit

Essential Kit

FDA UDI
MEDIVATORS INC.·40677964008328·Essential Kit includes Brush, Air/Water, Suctio...

Synergy Disc Instruments

FDA UDI
Synergy Spine Solutions Inc·M67091000009260·Trial, Small, 6mm, 6°

TUFF TT IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·April 16, 2025

TUFF TT IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·April 16, 2025

MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIA

FDA 510(k)
FDA Class 2 ·Cardiovascular

APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER

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

TUFF TT IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·February 24, 2026

OXFORD CEMENTLESS TIBIA B LM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code HRY·June 29, 2018

OT ULTRALINK METER

FDA Adverse Event
Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 13, 2013

UNKNOWN ZIMMER MIS TIBIAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JWH·February 18, 2011

LADARVISION

FDA Adverse Event
Injury ·ALCON-ORLANDO TECHNOLOGY CENTER·Product code LZS·February 20, 2008

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·June 19, 2025

Xhibit Telemetry Receiver, Model: 96280

FDA Enforcement
Class II ·Ongoing·Spacelabs Healthcare, Inc.·August 17, 2022

Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013

Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

FDA Enforcement
Class II ·Ongoing·Covidien·August 28, 2024