11 results · 27ms · 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.

HELFET ELBOW PROSTHESIS

FDA 510(k)
FDA Class 2 ·Orthopedic

ACUMED

FDA UDI
Acumed LLC·10806378097782·FFN 3.1mm Reamer

CENEFOM PVA SURGICAL SPEAR

FDA 510(k)
FDA Class 2 ·Ophthalmic

LIQUICHEK LIPIDS CONTROL, MODEL 641, 642

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HEARTSTART ONSITE

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

PATIENT INTERFACE 8253410 NIM NEURO 3.0

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED, INC.·Product code ETN·October 18, 2012

ANTI-REFLEC Y-SET 8"

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code ---·August 17, 2010

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

ACCOLADE SR SL MRI (Model L310)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025