18 results
·
27ms
·
Sources: EU EUDAMED, US FDA
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