230 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Prosthetic Kit Empty
FDA UDI
Paragon Implant Mfg., LLC·00810157310019·Prosthetic Kit Empty
Prosthetic Kit Tray (empty)
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307124696·
PRO-KINETIC ENERGY 3.0/9
FDA Adverse Event
Malfunction
·BIOTRONIK AG·Product code MAF·August 22, 2017
PRO-KINETIC ENERGY 5.0/15
FDA Adverse Event
Malfunction
·BIOTRONIK AG·Product code MAF·April 6, 2017
INFINITI VISION SYSTEM
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 10, 2008
CBC II-(3/16" KIT) PKE/6 WORLD
FDA Adverse Event
Injury
·STRYKER INSTRUMENTS PUERTO RICO·Product code CAC·March 12, 2012
CHOLECYSTECTOMY TRAY
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code PKE·March 16, 2017
TELEFLEX
FDA Adverse Event
Injury
·TELEFLEX·Product code PKE·February 28, 2018
CHOLECYSTECTOMY TRAY
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code PKE·June 14, 2016
JARIT
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES CORPORATION·Product code PKE·April 28, 2016
LAPAROSCOPIC CHOLECYSTECTOMY KIT
FDA Adverse Event
Malfunction
·LEESAR, INC.·Product code PKE·December 7, 2015
HENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482
FDA Recall
Open, Classified
·Stradis Medical, LLC dba Stradis Healthcare·Product code PKE·November 2, 2022
Sterile Custom Packs to be used in surgical procedures.
FDA Recall
Terminated
·American Contract Systems Jackson Pointe Commerce·Product code PKE·April 13, 2020
Laparoscopic Cholecystectomy Kit
FDA classification
FDA Class 1
·Laparoscopic Cholecystectomy Kit
PDE
FDA UDI
HAMAMATSU PHOTONICS K.K.·04582389010031·
pde-neoII
FDA UDI
HAMAMATSU PHOTONICS K.K.·04582389010543·
PDE-GEN3
FDA UDI
HAMAMATSU PHOTONICS K.K.·04582389010871·
pde-neo
FDA UDI
HAMAMATSU PHOTONICS K.K.·04582389010093·
M-KE
FDA UDI
Quality Aspirators, Inc.·00814005024370·M-KE
PIE MEDICAL IMAGING B.V.
FDA registration
PIE MEDICAL IMAGING B.V.·4 products·🇳🇱 Netherlands