Instrument, Ultrasonic Surgical

Product Code: LFL

Ultrasonic Medical Devices (Miscellaneous)

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]


Radiation TypeAcoustic
Radition SafetyNone
Annual ReportsNo

Products Classified as LFL

5927Instrument, Ultrasonic Surgical

Total Product Life Cycle (TPLC) Devices

5927Instrument, Ultrasonic Surgical

Pre-market Notifications for LFL

K200774CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation
K200427Sonicision Cordless Ultrasonic DissectorCovidien, Llc
K192963Kogent Torus Ultrasonic AspiratorKatalyst Surgical, LLC
K191555HARMONIC HD 1000i Shears, 20 Cm Length, HARMONIC HD 1000i Shears, 36 Cm LengthEthicon Endo-Surgery, LLC
K190281Ultrasonic Surgical SystemMediSonic Technology Co
K190180CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation
K190160NeXus Ultrasonic Surgical Aspirator SystemMisonix, Inc.
K190070Sonopet IQ Ultrasonic Aspirator SystemStryker Corporation
K182809CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation
K182272Reprocessed HARMONIC ACE+ 7 Shears With Advanced HemostasisSterilmed, Inc.
K181367Tenex Health TX System With The TXP MicroTipTenex Health, Inc.
K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple Lengths), Sonicision Battery Charger, Sonicision Battery Insertion GuideCovidien, Llc
K172691Ultrasonic GeneratorOLYMPUS MEDICAL SYSTEMS CORP.
K172595CUSA Excel+ Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation
K161882CUSA Clarity Ultrasonic Surgical Aspirator SystemINTEGRA LIFESCIENCES CORPORATION

Global Unique Device Identification Database

07613327291957Instrument, ultrasonic surgical
07613327291940Instrument, ultrasonic surgical
07613327291933Instrument, ultrasonic surgical
07613327291919Instrument, ultrasonic surgical
07613327291872Instrument, ultrasonic surgical
07613327291827Instrument, ultrasonic surgical
07613327291803Instrument, ultrasonic surgical
07613327289893Instrument, ultrasonic surgical
37613252518403Instrument, ultrasonic surgical
37613252518397Instrument, ultrasonic surgical
37613252518380Instrument, ultrasonic surgical
37613252518373Instrument, ultrasonic surgical
37613252051108Instrument, ultrasonic surgical
37613252026748Instrument, ultrasonic surgical
37613252026731Instrument, ultrasonic surgical

Maude Adverse Events

SONICISIONCOVIDIEN MFG DC BOULDER2020-03-31
SONICISIONCOVIDIEN MFG DC BOULDER2020-03-31
SONICISIONCOVIDIEN MFG DC BOULDER2020-03-31
HARMONIC HD 1000I SHEARS 36CM SHAFTETHICON ENDO-SURGERY, LLC.2020-03-31
HARMONIC HD 1000I SHEARS 36CM SHAFTETHICON ENDO-SURGERY, LLC.2020-03-31
HARMONIC HD 1000I SHEARS 36CM SHAFTETHICON ENDO-SURGERY, LLC.2020-03-31
HARMONIC ACE PLUS 7 ADV HEMOSTASIS 23ETHICON ENDO-SURGERY, LLC.2020-03-31
HARMONIC LAP 5MM SHEAR 36CMETHICON ENDO-SURGERY, LLC.2020-03-31
HARMONIC LAP 5MM SHEAR 36CMETHICON ENDO-SURGERY, LLC.2020-03-31
HARMONIC LAP 5MM SHEAR 36CMETHICON ENDO-SURGERY, LLC.2020-03-31
HARMONIC LAP 5MM SHEAR 36CMETHICON ENDO-SURGERY, LLC.2020-03-31
SONICISIONCOVIDIEN MFG DC BOULDER2020-03-31
SONICISIONCOVIDIEN MFG DC BOULDER2020-03-30
HARMONICETHICON ENDO-SURGERY, LLC2020-03-30
HARMONIC HD 1000I SHEARS 36CM SHAFTETHICON ENDO-SURGERY, LLC.2020-03-26
HARMONIC HD 1000I SHEARS 36CM SHAFTETHICON ENDO-SURGERY, LLC.2020-03-26
HS SYNERGY CURVED BLADEETHICON ENDO-SURGERY, LLC.2020-03-26
HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36ETHICON ENDO-SURGERY, LLC.2020-03-26
HARMONIC HD 1000I SHEARS 36CM SHAFTETHICON ENDO-SURGERY, LLC.2020-03-26
HARMONIC HD 1000I SHEARS 36CM SHAFTETHICON ENDO-SURGERY, LLC.2020-03-26
HS FOCUS 9CM PLUS ADAPTIVEETHICON ENDO-SURGERY, LLC.2020-03-26
HARMONIC ACE 36CM W ERG HANDLEETHICON ENDO-SURGERY, LLC.2020-03-26
HARMONIC ACE 36CM W ERG HANDLEETHICON ENDO-SURGERY, LLC.2020-03-26
HARMONIC LAP 5MM SHEAR 36CMETHICON ENDO-SURGERY, LLC.2020-03-26
HARMONIC LAP 5MM SHEAR 36CMETHICON ENDO-SURGERY, LLC.2020-03-26
HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36ETHICON ENDO-SURGERY, LLC.2020-03-26
HARMONIC HD 1000I SHEARS 36CM SHAFTETHICON ENDO-SURGERY, LLC.2020-03-26
HARMONIC HD 1000I SHEARS 36CM SHAFTETHICON ENDO-SURGERY, LLC.2020-03-26
HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36ETHICON ENDO-SURGERY, LLC.2020-03-26
ULTRASONIC GENERATOROLYMPUS MEDICAL SYSTEMS CORP.2020-03-26
SONICISIONCOVIDIEN MFG DC BOULDER2020-03-26
SONICISIONCOVIDIEN MFG DC BOULDER2020-03-26
SONICISION CORDLESS ULTRASONIC DISSECTORCOVIDIEN2020-03-26
SONICBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIPOLYMPUS MEDICAL SYSTEMS CORP.2020-03-25
SONICISIONCOVIDIEN2020-03-25
HARMONIC HD 1000I SHEARS 36CM SHAFTETHICON ENDO-SURGERY, LLC.2020-03-25
HARMONIC HD 1000I SHEARS 36CM SHAFTETHICON ENDO-SURGERY, LLC.2020-03-24
HARMONIC HD 1000I SHEARS 36CM SHAFTETHICON ENDO-SURGERY, LLC.2020-03-24
HARMONIC HD 1000I SHEARS 36CM SHAFTETHICON ENDO-SURGERY, LLC.2020-03-24
HARMONIC HD 1000I SHEARS 36CM SHAFTETHICON ENDO-SURGERY, LLC.2020-03-24
HARMONIC ACE 36CM W ERG HANDLEETHICON ENDO-SURGERY, LLC.2020-03-24
HARMONIC LAP 5MM SHEAR 23CMETHICON ENDO-SURGERY, LLC.2020-03-24
TX1 TISSUE REMOVAL SYSTEM - MICROTIPTENEX HEALTH, INC.2020-03-23
HARMONIC HD 1000I SHEARS 36CM SHAFTETHICON ENDO-SURGERY, LLC.2020-03-23
SONOSURG SCISSORS 5 MM O.D., HF SERIESOLYMPUS MEDICAL SYSTEMS CORP.2020-03-23
HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36ETHICON ENDO-SURGERY, LLC.2020-03-20
HARMONIC HD 1000I SHEARS 36CM SHAFTETHICON ENDO-SURGERY, LLC.2020-03-20
HARMONIC HD 1000I SHEARS 36CM SHAFTETHICON ENDO-SURGERY, LLC.2020-03-20
HARMONIC LAP 5MM SHEAR 36CMETHICON ENDO-SURGERY, LLC.2020-03-19
HARMONIC HD 1000I SHEARS 20CM SHAFTETHICON ENDO-SURGERY, LLC.2020-03-19

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