24 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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New Deantronics Smoke Evacuation Adapter with 10mm connector. New Deantronics Smoke Evacuation Adapter with 22mm connector. New Deantronics Button Switch Electrosurgical Pencil with SA01 Adapter. New Deantronics Button Switch Electrosurgical Pencil with SA02 Adapter.
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LEONE SPA
FDA UDI
LEONE SPA·08033707014119·CALIBRA 1ST MOL BANDS W/G8325-02 n.UR 31
5.2MHZ PENCIL PROBE 7'
FDA UDI
PARKS MEDICAL ELECTRONICS, INC.·00816787020762·
Femoral Head
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215053499·
Signature Femoral Head
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215001728·
Paxeon Femoral Head
FDA UDI
PAXEON RECONSTRUCTION LLC·08177570200078·Paxeon Head 36mm, CoCr Size S
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161111520310·Femoral Head, SIZE 36mm, (S) CoCr Alloy
POWDERED LATEX SURGEON'S GLOVE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GALAXY LITE
FDA 510(k)
FDA Class 1
·Physical Medicine
SIGNATURE Head - CoCr
FDA UDI
AMPLITUDE SAS·03701089520645·
ECOLAB
FDA Adverse Event
ECOLAB·Product code LHC·January 21, 2016
ECOLAB
FDA Adverse Event
ECOLAB·Product code LHC·January 21, 2016
ECOLAB
FDA Adverse Event
ECOLAB·Product code LHC·January 21, 2016
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014
GYNECARE GYNEMESH* PS
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTO·June 7, 2013
RADIAL JAW 4 BIOPSY FORCEPS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA·Product code FCL·July 7, 2011
WARMER DRAPE
FDA Adverse Event
Malfunction
·MICROTEK DOMINICANA, S.A.·Product code LHC·February 17, 2016
WARMER DRAPE
FDA Adverse Event
Malfunction
·MICROTEK DOMINICANA, S.A.·Product code LHC·February 12, 2016
Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 20, 2013
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023