11 results · 21ms · Sources: EU EUDAMED, US FDA

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Nano FortiCore, FortiCore

FDA 510(k)
FDA Class 2 ·Orthopedic

STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH

FDA 510(k)
FDA Class 2 ·Hematology

NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS

FDA 510(k)
FDA Class 1 ·General Hospital

ZEPHYR XL DR

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·January 13, 2014

MECHANICAL WALKER, ROLLATOR

FDA Adverse Event
DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code ITJ·June 26, 2013

CURLIN ADMINISTRATION SET

FDA Adverse Event
Malfunction ·MOOG MEDICAL DEVICES GROUP·Product code FRN·July 29, 2011

BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code DQO·November 26, 2025

Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.

FDA Enforcement
Class III ·Terminated·Diagnostica Stago, Inc.·September 24, 2014

1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182; 2. Guardia" Access Nano Embryo Transfer Catheter, Catalog Number: K-JETS-551910-L, Global Product Number: G24215; 3. Sydney IVF¿ Embryo Transfer Set, Product Number: K-JETS-7019-SIVF, Global Product Number: G18740

FDA Enforcement
Class II ·Terminated·Cook Inc.·April 4, 2018

1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182; 2. Guardia" Access Nano Embryo Transfer Catheter, Catalog Number: K-JETS-551910-L, Global Product Number: G24215; 3. Sydney IVF Embryo Transfer Set, Product Number: K-JETS-7019-SIVF, Global Product Number: G18740

FDA Recall
Terminated ·Cook Inc.·Product code MQF·December 19, 2017

Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024