17 results · 21ms · Sources: EU EUDAMED, 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