10 results · 24ms · 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.

VERTEFIX PEDICLE SCREW SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS

FDA 510(k)
FDA Class 2 ·Radiology

DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS

FDA 510(k)
FDA Class 2 ·Orthopedic

X3 TRIATHLON CS INSERT #3 9MM

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·May 13, 2014

ABRAMS MULTIDENSITY POLYURETHAN FOAM WOUND DRESSING SYSTEM

FDA Adverse Event
Other ·DR LEN'S MEDICAL PRODUCTS·Product code FRO·October 11, 2005

OUTLOOK ES

FDA Adverse Event
Malfunction ·B. BRAUN MEDICAL, INC.·Product code FRN·April 12, 2013

PRECISION XTRA

FDA Adverse Event
Malfunction ·Product code NBW·April 19, 2011

BIPOL LEAD MODEL 300

FDA Adverse Event
Injury ·CYBERONICS, INC.·Product code LYJ·June 20, 2008

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

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015