FDA.reportPublic FDA data

BOMI

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30032138833003213883BOMIMED INC.1N2026-01-011-100 IRENE STREET WINNIPEG, Manitoba CA R3T 4E1
30130777513013077751BOMI1N2026-01-01Camino de Noviciado 3707 Modulo 1 Pudahuel Santiago Region Metropolitana CL 9020000

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
10629160000049BOMImed Saver - BOMImed Disposable Saver Laryngoscope Blade204-633-2664regulatory@bomimed.com
10629160000339FEATHER-FLEX - 3 LITRE DISPOSABLE LATEX FREE BREATHING BAG204-633-2664regulatory@bomimed.com
10629160000346FEATHER-FLEX - 2 LITRE DISPOSABLE LATEX FREE BREATHING BAG204-633-2664regulatory@bomimed.com
10629160012608AQUESURE FILTER HUMIDIFIER - Breathing circuit filter with built-in humidification800-667-6276info@bomimed.com
20629160000046BOMImed Saver - BOMImed Disposable Saver Laryngoscope Blade204-633-2664regulatory@bomimed.com
20629160000053BOMImed Saver - BOMImed Disposable Saver Laryngoscope Blade204-633-2664regulatory@bomimed.com
20629160000305FEATHER-FLEX - 3 LITRE DISPOSABLE LATEX FREE BREATHING BAG204-633-2664regulatory@bomimed.com
20629160000350FEATHER-FLEX - 2 LITRE DISPOSABLE LATEX FREE BREATHING BAG204-633-2664regulatory@bomimed.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2790171649676110K990144INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMNAY2000-07-11
776231948985664K930957ZEFON GAS SAMPLING LINESCCK1993-07-02
776231977558278K851070RESP-BAC BACTERIA FILTERCAH1985-06-14
2790171712454783K252069da Vinci SP Surgical System (SP1098)NAY2025-12-02
2790172073620076K201146Ion Endoluminal SystemEOQ2020-06-26
2790171317532513K192803da Vinci Xi Surgical System, da Vinci X Surgical SystemNAY2020-04-29
2790171838498386K192367Ion Endoluminal SystemEOQ2019-11-26
2790171807204684K191736da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30NAY2019-07-26
2790171865640334K191529da Vinci Xi Surgical System, da Vinci X Surgical SystemNAY2020-02-06
2790171682044864K191280E-100 Electrosurgical Generator, SynchroSealNAY2019-11-14
2790171849454782K191043da Vinci Handheld CameraGCJ2019-06-06
2790171318573614K190999SureForm 45 Curved Tip, SureForm 45 Gray ReloadNAY2019-07-12
2790171412807843K183224SureForm 45, SureForm 45 ReloadsNAY2019-01-18
2790171327412692K183139Endoscope Sterilization TrayKCT2019-02-01
2790171701227604K183107Intuitive Surgical Vessel Sealer ExtendNAY2018-12-11
2790171996153611K183086da Vinci X and Xi Surgical SystemNAY2020-03-31
2790171384052137K182643IRIS 1.0 SystemLLZ2019-02-22
2790171023001908K182371da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesNAY2019-03-14
2790171353974353K182188Ion Endoluminal System ; Flexision Biopsy NeedleEOQ2019-02-14
2790171245294265K182140da Vinci Xi Surgical System, da Vinci X Surgical SystemNAY2018-10-24
2790171652618447K181395Universal Cannula Seal (5-12 mm)GCJ2018-07-27
2790171259658604K180964Endoscope Sterilization TrayKCT2018-09-28
2790171509308041K180351EndoWrist Mercury Bipolar GrasperNAY2018-08-07
2790172001832704K1800338mm Monopolar Curved ScissorsNAY2018-04-06
2790171851755254K173906da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesNAY2018-05-31
2790171667067088K173721SureForm 60 and SureForm 60 ReloadsNAY2018-07-05
2790171879286938K173585da Vinci Xi Surgical System, da Vinci X Surgical SystemNAY2018-07-19
2790171230879251K173415EndoWrist 5mm Thoracic GrasperNAY2018-05-31
2790171306520926K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendNAY2018-04-26
2790171114473670K172643da Vinci Xi Surgical System; da Vinci X Surgical SystemNAY2018-01-31
2790171466225023K171699da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical SystemNAY2017-07-28
2790171951476221K171632da Vinci Xi Surgical SystemNAY2017-09-19
2790171903555570K171426da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degreeNAY2017-06-13
2790171991855356K171388EndoWrist Stapler 45 System and Stapler 45 ReloadsNAY2017-05-31
2790171773635835K171294da Vinci X Surgical SystemNAY2017-05-26
2790171500864152K170879IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable AccessoriesNAY2017-09-21
2790171407970436K170865EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and AccessoriesNAY2017-04-21
2790171297692357K170713da Vinci Xi Surgical SystemNAY2017-06-13
2790171873047453K170645da Vinci Xi EndoWrist Instruments and AccessoriesNAY2017-09-11
2790171298067783K170644da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm)NAY2017-09-11
2790171887523700K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesNAY2017-09-21
2790171279671856K170640Endoscope Sterilization TrayKCT2017-09-17
2790171112190839K162973EndoWrist Suction IrrigatorNAY2017-02-06
2790171148924273K162411da Vinci Xi 12 – 8 mm ReducerNAY2016-09-21
2790172021064938K161271da Vinci Xi Surgical SystemNAY2016-07-11
2790171448867061K161178da Vinci Xi Surgical SystemNAY2017-01-19
2790171192325573K153276da Vinci Xi Surgical SystemNAY2016-08-07
2790171045176031K153126da Vinci Xi Hasson ConeGCJ2015-12-09
2790171704071581K152892da Vinci Xi Surgical SystemNAY2016-04-29
2790171131717527K152663Bladeless Optical ObturatorsGCJ2015-10-16
2790171902014994K152578da Vinci Surgical System, Model IS4000NAY2016-03-30
2790171566601086K152448da Vinci Single-Site Instrument and AccessoriesNAY2016-03-09
2790171672985548K152421IS4000 Stapler 30 Instrument and Stapler 30 ReloadsNAY2016-03-04
2790171232716681K151794da Vinci Xi Surgical SystemNAY2016-01-15
2790172001405190K151450Endoscope Sterilization TrayKCT2016-01-12
2790171022836725K150837IS4000 Small Clip Applier, IS4000 Long Bipolar ForcepsNAY2015-04-29
2790171941799083K150284IS4000 da Vinci EndoWrist InstrumentsNAY2015-05-15
2790171055232770K14321712 mm & Stapler Bladeless ObturatorsNAY2014-12-03
2790171655171763K143132IS4000 8mm Harmonic ACE Curved ShearsNAY2015-04-02
2790171668534900K142937Endoscope Sterilization TrayKCT2015-02-24
2790171695985462K14268312 mm Endoscopes and AccessoriesNAY2014-12-10
2790171797047205K140553ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADSNAY2014-07-25
2790171938095292K140189ENDOWRIST VESSEL SEALERNAY2014-06-05
2790171616657321K133942ENDOSCOPE STERILIZATION TRAYKCT2014-08-01
2790172066551524K1338458MM TROCAR KITGCJ2014-02-19
2790171762280882K133167MONOPOLAR CAUTERY CORD, BIPOLAR CAUTERY CORDGEI2014-01-07
2790171443792233K131861DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIESNAY2014-03-28
2790171791132569K130726DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOKNAY2013-06-07
2790171868926009K130266ENDOWRIST ONE VESSEL SEALERNAY2013-08-29
2790171505297784K123463INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALSNAY2012-12-03
2790171252929030K113706ENDOWRIST STAPLER SYSTEMNAY2012-10-17
2790171601899810K1125845MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERTNAY2011-09-29
2790171397979857K112263MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORYNAY2011-10-07
2790171707849165K112208INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIESNAY2011-12-08
2790171643151995K110639ENDOWRIST ONE VESSEL SEALERNAY2011-12-28
2790171114366981K110451ENDOWRIST ONE SUCTION/IRRIGATORNAY2011-08-26
2790171021703102K1017435MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319NAY2011-02-04
2790172014737647K101077DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100GCJ2011-02-04
2790171291271836K0932175 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)NAY2010-01-21
2790171989221702K082497INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENTNAY2009-05-07
2790171349551793K081137INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000NAY2009-02-18
2790171960203829K080155MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEMGCJ2008-03-06
2790171356004576K073112DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253NVE2008-08-01
2790171628016493K072627INTUITIVE SURGICAL DA VINCI AND DA VINCI S SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST INTRODUCERNAY2008-02-07
2790171741866341K072211INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYSKCT2008-02-28
2790171778391140K071405PROBE HOLDER SYSTEMLKF2007-10-09
2790171567778987K070947INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST CARDIAC PROBE GRASPERNAY2008-02-14
2790171572440495K063220DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000NAY2006-12-01
2790171251632096K061260INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214NAY2006-05-18
2790171240858573K060391INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182NAY2006-04-10
2790171737257236K050369INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000NAY2005-04-29
2790171367944853K050322MICROTEK EQUIPMENT DRAPESKKX2005-05-17
2790171628733083K050005INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180NAY2005-01-25
2790171739415148K042855INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENTNAY2004-11-12
2790171666197795K040948INTUITIVE SURGICAL ENDOPASS ENDOSCOPIC DELIVERY INSTRUMENT, MODEL P/N 400170NAY2004-05-05
776231082869924K033008AIR SAFETY HEPA AND NON-HEPA FILTERSCAH2004-05-13
2790171707456219K013416INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILYGEI2002-01-10
2790172052524529K012833INTUITIVE SURGICAL BIPOLAR FORCEPSNAY2001-11-16
2790171176113119K010007ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAPGCJ2001-02-22
776231265513819
776231453086611
776231888439158
776231908655993
776231968851974
776231025810002
2790171057668697
2790171224017324
2790171895476717
2790171922929778
776232052186331

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NAY722025-12-02
GCJ82019-06-06
KCT72019-02-01
EOQ32020-06-26
GEI22014-01-07
CAH22004-05-13
LLZ12019-02-22
NVE12008-08-01
LKF12007-10-09
KKX12005-05-17
CCK11993-07-02

GUDID#