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

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CENTRICITY PACS

FDA 510(k)
FDA Class 2 ·Radiology

Shiley

FDA UDI
Covidien LP·40884521068224·Evac Oral Tracheal Tube Seal Guard, Murphy Eye

Mallinckrodt

FDA UDI
Covidien LP·10884521068223·Evac Oral Tracheal Tube,Seal Guard, Murphy Eye

JOBST SensiFoot

FDA UDI
BSN MEDICAL, INC.·00035664108755·SENSIFOOT 8-15 MM HG MINI CREW EXTRA SMALL WHIT...

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306819285·Simpson-Wylie Vein Retractor 1" x 7"

HYCARE LATEX EXAMINATION GLOVE, POWDERED

FDA 510(k)
FDA Class 1 ·General Hospital

CEROX, MODEL 321OF

FDA 510(k)
FDA Class 2 ·Cardiovascular

GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 12 MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 6, 2022

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 7, 2025

LOGIC TIBIA PS MOD INSRT SZ 6 9MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·October 17, 2023

TOSHIBA Kalare Diagnostic X-Ray System K110785

FDA Recall
Terminated ·Toshiba American Medical Systems Inc·Product code JAA·April 3, 2013

CHARGING SYSTEM

FDA Adverse Event
Injury ·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013

ENDOVIVE? JEJUNAL FEEDING TUBE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - SPENCER·Product code KNT·September 23, 2014

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·June 2, 2011

TOSHIBA Kalare Diagnostic X-Ray System K110785

FDA Enforcement
Class II ·Terminated·Toshiba American Medical Systems Inc·July 17, 2013

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

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