23 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668101100·HELVESTON "GREAT BIG BARBIE" RETRACTOR 11MM
Cascade
FDA UDI
CADWELL INDUSTRIES, INC.·00840067100554·Cascade 16Ch Amplifier
BINAXNOW COVID-19 AG CARD
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·October 10, 2022
POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR
FDA 510(k)
FDA Class 1
·General Hospital
OPTICAL INTEGRITY LASERGUARD FIBERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MICRUSFRAME18 15MM X 50CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·December 1, 2020
CONTOUR TEST STRIPS (50)
FDA Adverse Event
Injury
·BAYER HEALTHCARE LLC·Product code NBW·November 4, 2008
MINIMED 530
FDA Adverse Event
Malfunction
·MEDTRONICS·Product code FRN·October 15, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
ESPIRIT
FDA Adverse Event
Injury
·SORIN GROUP ITALIA S.R.L.·Product code NVZ·June 21, 2013
Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System
FDA Enforcement
Class II
·Terminated·Philips Healthcare Inc.·August 15, 2012
OT VERIO FLEX METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE GMBH·Product code NBW·July 22, 2021
ROD,FIXATION,INTRAMEDULLARY
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·October 1, 2018
ENRHYTHM
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NVZ·April 10, 2018
OT VERIO FLEX METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE GMBH·Product code NBW·July 22, 2021
PROSTHESIS, RIB REPLACEMENT
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code MDI·June 11, 2019
PROSTHESIS, RIB REPLACEMENT
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code MDI·June 11, 2019
PROSTHESIS, RIB REPLACEMENT
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code MDI·June 11, 2019
ROD, FIXATION, INTRAMEDULLARY
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·June 11, 2019