13 results · 24ms · Sources: EU EUDAMED, US FDA

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METRICATH SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

JOBST forMen

FDA UDI
BSN MEDICAL, INC.·04042809867671·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND CLOSED...

REPROCESSED ENDOSCOPIC ELECTRODES

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

CORDLESS COMPACT MOBILE X-RAY SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

EMAX 2 PLUS MOTOR

FDA Adverse Event
Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·April 2, 2013

CONCERTO II CRT-D

FDA Adverse Event
Death ·MEDTRONIC MED REL, INC.·Product code NIK·April 6, 2011

VITALITY DS VR

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

THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

FDA Adverse Event
Death ·THORATEC CORPORATION·Product code DSQ·June 14, 2024

NFLEX CURVED ROD 60MM-STERILE

FDA Adverse Event
Injury ·SYNTHES ELMIRA·Product code NQP·March 31, 2016

NCB, DF PLATE, RIGHT, 13 HOLES, 324 MM

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code HRS·June 11, 2018

PKG, METZENBAUM SCISSORS, CURVED LONG, P/N 0250080265. 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