12 results · 23ms · 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.

BARD MALE EXTERNAL CATHETER

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

N/A

FDA UDI
SALTER LABS·00607411301995·Nasal Cannula (Adult) Salter Style® with 1’ (1,...

LEONE SPA

FDA UDI
LEONE SPA·08033707062349·TUBE MIM 22/45 OCC LEFT

LEONE SPA

FDA UDI
LEONE SPA·08033707056454·DB TUBE MIM 22/45 OCC LEFT

Aqueduct 200 Cervical Dilation Balloon Catheter

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

MOORVMS-PRES PRESSURE CUFF CONTROLLER

FDA 510(k)
FDA Class 2 ·Cardiovascular

HEARTSTART FRX

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 21, 2014

SPARC SLING SYSTEM

FDA Adverse Event
Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·October 19, 2012

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·May 26, 2015

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

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

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