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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

PROVOCATIVE SENSITIVITY BALLOON

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

GRADIA®

FDA UDI
Gc America Inc.·D0479011251·GRADIA PLUS GLP-Bright Red, 0.8ml, 1pc

Integra DP Valve System

FDA UDI
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)·10381780033219·Integra DP Valve System is an implantable devic...

BIOPSY CUP INSERT

FDA UDI
SONTEC INSTRUMENTS, INC.·B09929011250·BIOPSY CUP WITH THORN DOUBLE-ACTION JAWS FOR TU...

HALO MOLAR BAND

FDA UDI
Ortho Arch Company Inc·D90990112515·U6R HALO MOLAR BAND .022/.045 DBL NON-CV HG TO ...

Elite® Bondable Buccal Tubes

FDA UDI
Ortho Organizers, Inc.·00190707071080·Elite®.022 BIO L6R DBT/HK DB

CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING

FDA 510(k)
FDA Class 1 ·Ophthalmic

BD SYRINGE WITH NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·November 15, 2020

BD SYRINGE¿ WITH NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·January 12, 2023

SYRINGE S2 2ML 23GA 1-1/4IN BD CHINA

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·January 15, 2021

SYRINGE S2 2ML 23GA 1-1/4IN

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·November 4, 2019

BD SYRINGE SYRINGE INJECTOR WITHOUT RUBBER STOPPER

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·January 20, 2023

UNIFY CRT-D

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·June 30, 2014

SCREW

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·January 8, 2013

SIMPLEX P - US TOBRA FD 10-PK

FDA Adverse Event
Malfunction ·STRYKER ORTHOPAEDICS LIMERICK·Product code LOD·November 10, 2010

BD SYRINGE WITH NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·October 1, 2019

Escherichia coli Polyvalent 3 Types O86(B7), O114:K90, O125(B15), O127(B8), O128

FDA UDI
REMEL EUROPE LIMITED·05056080501857·

BASE SYSTEM ILLU

FDA Adverse Event
Malfunction ·LIEBEL-FLARSHEIM·Product code DXT·March 4, 2024

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024