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.

RA 80 EIKEN KIT DETERM. OF RHEUMATIC F.

FDA 510(k)
FDA Class 2 ·Immunology

ACUMED

FDA UDI
Acumed LLC·10806378097683·FFN Base Plate

KETAC-CEM IN REF. TO K802048

FDA 510(k)
FDA Class 2 ·Dental

LATEX EXAMINATION GLOVES, POWDERED, (CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM).

FDA 510(k)
FDA Class 1 ·General Hospital

DISPOSABLE VINYL SYNTHETIC EXAMINATION GLOVES, POWDERED

FDA 510(k)
FDA Class 1 ·General Hospital

VERSYS FEMORAL HEAD

FDA Adverse Event
Malfunction ·ZIMMER·Product code JDI·February 21, 2014

XLD 110V L.A. REF

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·October 18, 2012

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·May 28, 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