11 results · 19ms · 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.

GAMMA LEWIS BLOOD GROUP SUBSTANCE

FDA 510(k)
FDA Class 2 ·Hematology

LEONE SPA

FDA UDI
LEONE SPA·08033707056577·DB TUBE MIM 22/18/51 OCC LEFT

Bonecam

FDA UDI
MEDLINE INDUSTRIES, INC.·00818614022185·Drill with depth stop, 3.3mm

ACUMED

FDA UDI
Acumed LLC·10806378102080·2.8mm X 450mm Threaded Guide Wire

ROTATING GAMMA SYSTEM INFINI (INFINI)

FDA 510(k)
FDA Class 2 ·Radiology

TCD 100M, PWD13 TRANSDUCER

FDA 510(k)
FDA Class 2 ·Radiology

VICTORY XL DR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·May 9, 2014

NIGHT GUARD

FDA Adverse Event
Malfunction ·RANIR LLC·Product code OBR·October 19, 2012

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·ANIMAS CORP·Product code LZG·August 9, 2010

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

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

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