13 results
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24ms
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Sources: EU EUDAMED, US FDA
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