19 results · 20ms · Sources: EU EUDAMED, US FDA

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ClariVein IC

FDA 510(k)
FDA Class 2 ·Cardiovascular

LEONE SPA

FDA UDI
LEONE SPA·08033707014942·CALIBRA 1ST MOL BANDS W/G8325-03 n.UL 2

Symmetry Jacobson

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482055762·Symmetry® Forceps, Jacobson Mosquito, Curved, M...

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100288·SAUER PREMATURE INFANT SPECULUM 2MM

GUTTA PERCHA POINTS

FDA UDI
DiaDent Group International·08806383507516·Gutta Percha Points is used to root canal filin...

HNM Medical

FDA UDI
HNM STAINLESS, LLC.·00842962111314·MICRO JACOBSON FORCEPS, 4", CVD

NEWPORT E360 VENTILATOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001

FDA 510(k)
FDA Class 2 ·Immunology

ESON 2 NASAL MASK

FDA Adverse Event
Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·August 14, 2019

GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 2+ L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 26, 2021

A) Presource PBDS, Lap Chole, Kit, Clean Up; B) Presource PBDS, Greenwood LeFlore Hosp, Lap Chole, Kit

FDA Enforcement
Class I ·Terminated·Cardinal Health, Medical Products & Services·May 15, 2013

QUADRA ASSURA CRT-D, DF-4 CONNECTOR

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·October 8, 2014

CAPSURE Z NOVUS

FDA Adverse Event
Injury ·MPRI·Product code DTB·June 8, 2013

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 21, 2011

PATIENT INFORMATION CENTER IX

FDA Adverse Event
Death ·PHILIPS MEDICAL SYSTEMS·Product code MHX·March 15, 2023

PATIENT INFORMATION CENTER IX

FDA Adverse Event
Death ·PHILIPS MEDICAL SYSTEMS·Product code MHX·November 9, 2023

BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231758¿

FDA Enforcement
Class II ·Ongoing·Becton Dickinson & Co.·February 14, 2024

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021