18 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.

HEADFIX

FDA 510(k)
FDA Class 2 ·Radiology

Latitude

FDA UDI
TORNIER, INC.·00840338602237·Ulnar Tray

IMPLANTABLE ELECTRODE LEAD, MODEL 030-439

FDA 510(k)
FDA Class 3 ·Cardiovascular

VIVANT BREAST LESION LOCALIZATION DEVICE

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

DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 2 (PHEMFILCON A) SHERICAL ( HYDROPHILIC)C

FDA 510(k)
FDA Class 2 ·Ophthalmic

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·July 13, 2017

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·July 13, 2017

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·January 7, 2016

ASR ACETABULAR CUPS 50

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·April 2, 2013

RESTORE ADVANCED RECHARGEABLE

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·March 9, 2011

COBAS INTEGRA 400

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·April 17, 2008

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·February 2, 2021

Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 18965040S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

FDA Enforcement
Class II ·Terminated·Stryker GmbH·June 24, 2020

MITRACLIP CLIP DELIVERY SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR·Product code NKM·April 29, 2020

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·February 11, 2021

Spirit One A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·May 4, 2016

Spirit One A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·May 4, 2016

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