21 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HONGYU DISPOSABLE SURGICAL DRAPES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CoRoent
FDA UDI
Nuvasive, Inc.·00887517577559·CoRoent Ant TLIF PEEK, 14x11x32mm 4°
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331158759·operating scissors, blunt/blunt, straight, 5" (...
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515065789·Roch Pean Fcps, cvd, 7 1/4"
SCHWERT
FDA UDI
A. Schweickhardt GmbH & Co. KG·E8961413240·Periosteal elevators 10mm
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515018518·Roch-Pean Hemo Fcps, cvd, 7 1/4"
GE ECHOPAC MODEL BT10
FDA 510(k)
FDA Class 2
·Radiology
CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER
FDA 510(k)
FDA Class 2
·Dental
SUPERLINE
FDA Adverse Event
Injury
·DENTIUM USA·Product code DZE·October 3, 2014
LOCKSCR Ø2.4 SELF-TAP L20 TAN
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·June 3, 2013
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·June 1, 2011
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·November 20, 2017
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·December 19, 2017
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·January 8, 2019
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·January 22, 2019
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·January 29, 2018
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·January 26, 2018
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·February 12, 2018
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·January 29, 2018
Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophotometric and electrochemical techniques. The system has two core modules: one consisting of a spectrophoto-metric system for measurement of analytes using spectrophotometric techniques, such as end point, rate and turbidometric assays. The second module is an electro-meter used for measurement of electrolytes.
FDA Enforcement
Class III
·Terminated·ELITech Group B.V.·October 9, 2019