12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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14F DUAL FLOATING DIALYSIS CATHETER/TRAY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809867589·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND OPEN T...
K042172
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FPA·September 2, 2022
VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BOSS-2000-2 VACUUM ERECTION DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COLUMBUS UCR TIBIAL PLATEAU CEMENTED T2+
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code JHW·July 24, 2015
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·April 2, 2013
ECHELON
FDA Adverse Event
Injury
·SMITH & NEPHEW, ORTHOPEDICS·Product code JDH·April 6, 2011
CONTAK RENEWAL 3 RF
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008
PKG, KELLY FORCEPS, CURVED LEFT, P/N 0250080283. 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