17 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496042761·RELAX UNISEX 70, SIZE XXL, MOKA, GRADUATED COMP...
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809869729·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND CLOSED...
PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT
FDA 510(k)
FDA Class 2
·Dental
FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
XMAX MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code ERL·April 2, 2013
VITALITY DS VR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
UNICEL® DXC 600 PRO SYNCHRON ® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·April 6, 2011
OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY
FDA Adverse Event
Malfunction
·OGDEN MANUFACTURING PLANT·Product code KDI·July 21, 2018
OPTIFLUX 180NRE DIALYZER FINISHED ASSMBLY
FDA Adverse Event
Malfunction
·OGDEN MANUFACTURING PLANT·Product code KDI·August 13, 2018
OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY
FDA Adverse Event
Malfunction
·OGDEN MANUFACTURING PLANT·Product code KDI·July 27, 2018
DREAMSTATION AUTO CPAP W/HUM/CELL, DOM
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·September 22, 2021
SUPERA SELF-EXPANDING STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code NIP·March 4, 2024
Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·April 29, 2020
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
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024