12 results · 21ms · Sources: EU EUDAMED, US FDA

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RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

JOBST forMen

FDA UDI
BSN MEDICAL, INC.·04042809867626·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND OPEN T...

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 15, 2020

ASCENT KNEE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS

FDA 510(k)
FDA Class 2 ·Cardiovascular

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·July 3, 2019

GYNECARE GYNEMESH* PS

FDA Adverse Event
Injury ·ETHICON, INC.·Product code OTO·April 9, 2013

VITALITY AVT

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

OT ULTRA2 METER

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·April 6, 2011

PKG, BABCOCK FORCEPS, P/N 0250080241. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

FDA Enforcement
Class II ·Terminated·Stryker Endoscopy·December 24, 2014

Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

FDA Enforcement
Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019

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