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