16 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.

Disposable Medical Face Masks

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

NA

FDA UDI
Synthes GmbH·10886982144522·3.0MM CANNULATED SCREW LONG THREAD/19MM

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450191729·

Medical Facets NC

FDA UDI
MEDICAL FACETS NC LLC·M933MDF2027190·3.0mm Cannulated Screw, Long Thread, 19mm

Diamond Orthopedic, LLC

FDA UDI
DIAMOND ORTHOPEDIC, LLC·B551DMD2027190·3.0mm, Cannulated Screw, Long Thd., 19mm

FORMULA ONE POWDERED LATEX EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM 200 MICROGRAMS OR LESS AND MADE FROM A

FDA 510(k)
FDA Class 1 ·General Hospital

PHYSICAL MONITORING REGISTRATION UNIT

FDA 510(k)
FDA Class 2 ·Physical Medicine

BD LUER-LOK

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 31, 2025

BD LUER-LOK

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 23, 2024

BD LUER-LOK

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 13, 2024

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE REHABILITATION EQUIP·Product code ITI·October 27, 2014

UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code DHA·August 11, 2011

GYNECARE TVT OBURATOR SYSTEM

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTN·July 2, 2013

BD LUER-LOK

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 29, 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

EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021