10 results · 20ms · 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.

MYELOGRAPHY NEEDLE

FDA 510(k)
FDA Class 2 ·General Hospital

MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100

FDA 510(k)
FDA Class 2 ·General Hospital

Electric breast pump (model: M5)

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

LOGIC CR TIB INSERT STD, SZ 3, 13MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·September 30, 2024

HARMONIC ACE 36 CM

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·November 16, 2007

TANDEM T:SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES·Product code LZG·February 20, 2014

UNKNOWN DEPUY ASR IMPLANTS

FDA Adverse Event
Malfunction ·DEPUY INTL LTD·Product code KWA·December 10, 2010

Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

FDA Enforcement
Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

FDA Enforcement
Class II ·Terminated·STERILMED, INC.·December 16, 2015