FDA.reportPublic FDA data

GE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
GENTEEL, LLC5Y2026-01-012904 Rawhide St West Linn OR US 97068
GelSana Therapeutics, Inc.5N2026-01-0112635 E Montview Blvd Ste 210 Aurora CO US 80045
10557571000111022General Data Healthcare1N2026-01-011004 Seabrook Way Cincinnati OH US 45245
10558861000111208Genova Diagnostics1Y2026-01-0163 Zillicoa St Asheville NC US 28801
12158661215866GENTEX OPTICS, INC.1N2026-01-01183 WEST MAIN ST. DUDLEY MA US 01571
12204231220423GENZYME CORPORATION1N2026-01-0176 NEW YORK AVENUE FRAMINGHAM MA US 01701
12227731000120768GEOTEC, INC.1N2026-01-0189 Bellows St Warwick RI US 02888
12236621000159368GENERAL HOSPITAL SUPPLY CORP.1N2026-01-011050 Van Buren Ave Indian Trail NC US 28079
15168251516825Gentherm Medical, LLC1Y2026-01-0112011 MOSTELLER RD Cincinnati OH US 45241
15191791519179GEBAUER CO.1Y2026-01-014444 E. 153RD ST. Cleveland OH US 44128
15290413005214683GE Healthcare Coils1N2026-01-011515 DANNER DR AURORA OH US 44202
16496613001451797GERMAINE LABORATORIES, INC.1N2026-01-0111030 Wye Drive SAN ANTONIO TX US 78217
16511043002737156GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES1Y2026-01-01465 PAN AMERICAN DR STE 11 EL PASO TX US 79907
16521113003427273GENESIS BIOSYSTEMS INC.1N2026-01-011500 Eagle Ct. Lewisville TX US 75057
17171521717152General Air Service and Supply1N2026-01-016330 Colorado Blvd Commerce City CO US 80022
17207531720753GE OEC MEDICAL SYSTEMS, INC1Y2026-01-01384 N WRIGHT BROTHERS DR SALT LAKE CITY UT US 84116
17232411000517719GENESEE BIOMEDICAL, INC.1N2026-01-01700 W Mississippi Ave Unit D5 DENVER CO US 80223
18341771000160378GENERAL SCIENTIFIC CORP.1N2026-01-0177 ENTERPRISE DR. ANN ARBOR MI US 48103
19288901928890GEORGE KING BIO-MEDICAL, INC.1N2026-01-0111771 WEST 112TH ST. OVERLAND PARK KS US 66210
19370601000147357GENERAL PHYSIOTHERAPY II LLC1N2026-01-013683 New Town Blvd Saint Charles MO US 63301
20256942025694GEREONICS, INC.1N2026-01-01117 Sanctuary Irvine CA US 92620
20271132027113GENBIO1N2026-01-0115222 AVE. OF SCIENCE Suite A San Diego CA US 92128
20323503003309342GE PARALLEL DESIGN, INC.1N2026-01-014313 E COTTON CENTER BLVD STE 100 PHOENIX AZ US 85040
20839412083941GENLEE CORP.1Y2026-01-01769 Morningside Dr MILLBRAE CA US 94030
21227261000116747GE MEDICAL SYSTEMS, LLC1N2026-01-014855 West Electric Avenue Milwaukee WI US 53219

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
434131988041851P950034SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANEMCN1996-08-12
265981844139467P110006SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)PAA2012-09-18
266511529812695K994345MAGNA 5000 PHASED ARRAY CTL SPINE COILMOS2000-02-14
266512007275692K994040PHASED ARRAY KNEE AND FOOT COILMOS2000-01-18
266531569320109K993687UROVIEW 2800OWB1999-12-21
266531917174853K992506MINI 6800 DIGITAL MOBILE C-ARMOXO1999-08-19
438181998946062K991514GEBAUER'S CHLORIDE FINE NOZZEMLY1999-07-16
266531380220467K983529INSTATRAK 3000LLZ1998-12-31
3484891646506508K983449GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSORBZQ1999-02-08
538922023583110K983386BIOSTREP A-DIRECT STREP A ANTIGEN TESTGTY1998-11-25
266511774966627K983143MARK 5000 PHASED ARRAY SHOULDER COILMOS1998-11-16
266531084038149K981998PEDIATRIC INSTATRAK SYSTEMLLZ1998-08-21
538921159142977K981165AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TESTJHI1998-04-16
538922047667200K980531AIMSTEP PREGNANCYJHI1998-03-06
266511686591810K980157PREMIER 7000 CTL SPINE COILMOS1998-04-13
538921131508037K974512AIMSTICK PBD COMBO PREGNANCYDHA1998-01-02
538921520484209K974368AIMSTICK PBD PREGNANCYDHA1998-01-02
266531952618285K974355INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)OWB1998-02-17
347551067800876K974244IMMUNODOT MONO-M TESTLSE1998-09-22
347551139164271K974226IMMUNODOT MONO-G TESTLSE1998-09-22
347551894816299K973941IMMUNOWELL EBNA IGG TESTLLM1998-08-10
347551981374394K973940IMMUNOWELL EBV VCA IGG TESTLSE1998-08-10
347551123213297K973939IMMUNOWELL VCA IGM TESTLJN1998-08-10
538921976304035K973825MIDSTREAM HOME REGNANCY TESTDHA1997-12-19
266511983638837K972340INSIGHT 7000 PHASED ARRAY TORSO COILMOS1997-08-21
266511197037114K971667CARDIAC PHASED ARRAY COILMOS1997-07-23
347551695126382K971591INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS)LSQ1998-03-13
266531087033553K963952SERIES 9600 MOBILE DIGITAL IMAGING SYSTEMOWB1996-12-23
347552005737482K963055IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120LJZ1997-05-02
347551206546607K963054IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)LJZ1997-05-05
265981673444285K961002DIASONICS ITNRAOPERATIVE PROBESITX1997-01-22
266531098404298K960330INSTATRAKLLZ1996-04-08
347552043201716K953683MMUNO DOT BORRELIA DOT BLOT M TESTLSR1996-05-03
347551913583463K953682IMMUNO DOT BORRELIA DOT BLOT G TESTLSR1996-05-03
266532052516530K951765SERIES 6600 DIGITAL MOBILE C-ARMOXO1995-05-11
336701689608103K945856POSITIVE LUPUS ANTICOAGULANT PLASMAGGC1995-10-05
336701499108111K945855A-FACT, ABNORMAL FACTOR ASSAY CONTROLGGN1995-10-24
336701754003005K945854B-FACT, BORDERLINE FACTOR ASSAY CONTROLGGN1995-10-24
266531332283773K940295UROVIEW MODEL 2600JAA1994-08-22
481371934047936K934494SURGITELHOH1994-01-25
266531152821863K933447STENOSCOP MOBILE FLUOROSCOPIC XRAY SYSTEMOXO1993-08-23
266531607179219K9260569600 FLUOROSCOPIC IMAGING SYSTEMOXO1993-01-21
347551291590116K924843IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANELLLL1992-12-01
266511808495795K923264GENERAL PURPOSE FLEX COILLNH1992-09-30
347551022883181K920569INDXTM DIP-S-TICKSTMLSQ1993-02-09
347551839647671K920401IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TESTMID1992-08-20
347551701657832K920400IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TESTMID1992-08-20
347551863155528K914801IMMUNOWELL DSDNA ANTIBODY TESTDHC1991-12-09
347551946242917K911850IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TESTLKO1991-05-07
347551332571057K911849IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TESTLKO1991-05-07
347551521329842K911848IMMUNOWELL RNP/SM ANTIBODY TESTLKP1991-05-07
266511590389999K911806MAGNETIC RESONANCE DIAGNOSTIC ACCESSORYLNH1991-06-28
347551854187958K911627IMMUNODOT BORRELIA (LYME) TESTLSR1992-04-08
347552033342066K911590IMMUNOWELL BORRELIA (LYME)TESTLSR1991-12-20
347552026706366K905486IMMUNOWELL TPO (MICROSOME) TESTJNL1991-01-03
347551099478537K905485IMMUNOWELL THYROGLOBULIN TESTJZO1991-01-25
502911850835523K905067PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFTDSY1991-03-18
347551123218023K903843IMMUNODOT THYROID AUTOIMMUNITY PANELJNL1990-10-02
347551407810680K903047IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4LLL1990-08-09
502912053914802K901815MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARYDRE1990-07-03
347551212453431K901597INDX DIP S TICKSLSQ1990-12-21
502911075870383K901531PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBEDNP1990-06-20
347551819464735K896347IMMUNODOT AUTOIMMUNE SCREENING PANEL 1LJM1989-12-05
347551189302631K884898IMMUNODOT TORCH TEST RUBELLALFX1989-02-03
502911059227254K882981PTI INTRA-ART CORONARY ARTERY RETRACTION CLIPDWS1988-09-27
502911465730379K882381PTI HEART-LIFT(TM) CARDIAC RETRACTION GLOVES-STERIKGO1988-07-07
502911476763570K874927PTI HEART-CHILL(TM) CARDIAC INSULATING JACKETDWC1988-01-29
3353621351286480K870939VIBRACAREISA1987-04-06
538921813710655K864731OCEAN SCIENTIFIC VDRL TESTGMQ1987-03-10
538921001573648K863849LIQUI-SERA COMBO LIGAND/TDM CONTROLSJJY1986-11-24
347551032802012K861123THE GOLDEN QUAD TEST (CMV)GQI1987-02-02
347552007191521K861122THE GOLDEN QUAD TEST (TOXO)LJK1987-02-02
347551675773602K861120THE GOLDEN QUAD TEST (HSV)GQO1987-02-02
3484891356135602K861099GEREONICS BIOPOTENTIAL SKIN ELECTRODESDRX1986-08-06
3353621169579490K855129NEOCUSSOR (MASSAGER, BATTERY) POWEREDBYI1986-01-23
3353621345577488K852944FLEXIMATIC MASSAGERISA1985-09-05
538921943974880K821388SERO/TEX CRP TESTDCN1982-07-02
538921427156428K821319SERO/TEX RF TESTDHR1982-05-21
502911759538978K813459REUSABLE & DISPOSABLE TEMP. PROBESFLL1982-03-26
347551178974828K803134TOXOPLASMA GONDII SEROLOGICAL REAGENTSGLZ1981-01-29
265981228006311K260673LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 PowerIYN2026-03-24
265982053786010K260398LOGIQ eIYN2026-05-26
266511062007915K253780SIGNA™ BoltLNH2026-02-06
265981695495357K253370LOGIQ TotusIYN2026-01-08
265981684322365K253366LOGIQ FortisIYN2026-01-07
265981111491994K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22IYN2025-11-24
538921950235987K252283Nano-Check Influenza A+B TestPSZ2026-01-15
265982053695773K251985LOGIQ E10IYN2025-10-29
265981078030117K251963LOGIQ E10sIYN2025-10-29
266511186517738K251399SIGNA™ SprintLNH2025-09-11
265981846202890K251322Venue; Venue Go; Venue Fit; Venue SprintIYN2025-07-25
265981040314840K251169Vivid PioneerIYN2025-07-10
265981833596315K250543Voluson™ Performance 16; Voluson™ Performance 18IYN2025-05-29
538921340855761K244043AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupNFT2025-02-27
265981273874788K243628Vivid T9/Vivid T8IYN2025-02-11
265981905736941K243620Vivid iqIYN2025-02-11
266271816403130K243540Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)DQK2024-12-12
538921909249892K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test CupNGL2024-12-17
266271257674419K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX2025-07-09
265981519616603K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22IYN2024-12-20
265981955831828K242005Versana Premier; Versana Premier Lotus; LOGIQ FIYN2024-10-02
265981829127751K240111VenueIYN2024-06-10
265981060568579K240053Venue GoIYN2024-06-10
266272034590375K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) • Portrait™ Wearable Pulse OMWI2024-03-20
265981574908925K234106Venue FitIYN2024-06-10
266271182464020K233810Portrait VSMMWI2024-04-25
266531172499898K233669OEC 3DOXO2024-03-28
538921124747480K233417AllTest Fentanyl Urine Test CassetteNGL2023-10-26
317721832446941K232638FilteredFlo Warming BlanketsDWJ2023-10-24
502911371392637K232599TransForm McCarthy Mitral Annuloplasty Ring (TF)KRH2024-04-09
265981233237274K232381LOGIQ TotusIYN2023-12-07
265981507556663K232186LOGIQ eIYN2023-11-03
265981680768656K231989LOGIQ E10s, LOGIQ FortisIYN2023-11-07
265981803846471K231966LOGIQ E10IYN2023-11-07
265981113056635K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18IYN2023-10-30
266271743458197K231870CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing SystemDQK2023-12-13
317721986031799K231596IOB Temperature Management SystemDWJ2023-06-30
502911506118529K230679WellsForm Tricuspid Annuloplasty Band (WF)KRH2023-05-26
266271175583964K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01), Portrait™MWI2023-08-11
265981146882666K230346Voluson SWIFT; Voluson SWIFT+IYN2023-06-20

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN1422026-05-26
MOS412023-01-03
LNH212026-02-06
OWB152017-08-10
MHX122025-07-09
DQK122024-12-12
OXO112024-03-28
IYO72012-04-19
MLY62019-05-07
KRH52024-04-09
DWJ52023-10-24
LLZ52018-05-04
MWI42024-04-25
DPS42018-09-18
DHA42002-01-22
LSE42001-06-11
LSR41996-05-03
GGN32017-02-23
JXM32016-05-23
GTY32014-01-31
KHE32011-01-28
LSQ31998-03-13
NGL22024-12-17
OUO22017-02-14
LFG22015-08-18
MBI22014-06-26
NBW22013-06-21
DWC22012-12-18
ITX22012-08-17
JJY22008-09-17
LYR22003-06-10
JAA22003-03-20
JHI21998-04-16
LJZ21997-05-05
LLL21992-12-01
MID21992-08-20
LKO21991-05-07
JNL21991-01-03
ISA21987-04-06
PSZ12026-01-15

NDC#

CellCept

Genentech, Inc.

Mycophenolate Mofetil

CellCept

Genentech, Inc.

Mycophenolate Mofetil

CellCept

Genentech, Inc.

Mycophenolate Mofetil

CellCept

Genentech, Inc.

Mycophenolate Mofetil hydrochloride

Tamiflu

Genentech, Inc.

oseltamivir phosphate

Tamiflu

Genentech, Inc.

oseltamivir phosphate

Tamiflu

Genentech, Inc.

Oseltamivir Phosphate

Optison

GE Healthcare Inc.

Human Albumin Microspheres and Perflutren

Flyrcado

GE Healthcare Inc.

FLURPIRIDAZ F-18

Oxygen

General Distributing Co.

Oxygen

Nitrogen

General Distributing Company

Nitrogen

Air

General Distributing Company

Air

200 records. Showing 1-40. Next

PMA#

Aptima HPV 16 18/45 Genotype Assay

2022-02-25

GEN-PROBE INCORPORATED10210 Genetic Center Drivesan Diego, CA 92121 PMA NumberP120007 Supplement NumberS029 Date Received12/14/2021 Decision Date02/25/2022 Product Code OYB  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason ...

200 records. Showing 1-40. Next

PMN#

LOGIQ Totus

2026-01-08

GE Medical Systems Ultrasound and Primary Care Diagnostics

LOGIQ Fortis

2026-01-07

GE Medical Systems Ultrasound and Primary Care Diagnostics

LOGIQ E10s

2025-10-29

GE Medical Systems Ultrasound and Primary Care Diagnostics

HESTIA

2025-07-17

Genoray Co., Ltd.

Vivid Pioneer

2025-07-10

GE Medical Systems Ultrasound and Primary Care Diagnostics

Vscan Air

2025-05-01

GE Medical Systems Ultrasound and Primary Care Diagnostics

Vivid T9/Vivid T8

2025-02-11

GE Medical Systems Ultrasound and Primary Care Diagnostics

Vivid iq

2025-02-11

GE Medical Systems Ultrasound and Primary Care Diagnostics

Aurora

2025-01-17

Ge Medical Systems Israel, Functional Imaging

Clarify DL

2025-01-03

Ge Medical Systems Israel, Functional Imaging

OEC One ASD

2024-12-27

Ge Hualun Medical Systems Co. , Ltd.

200 records. Showing 1-40. Next

Applications#

221287

GENERAL AIR SERVICE & SUPPLY COMPANY

220634

GENERAL DISTRIBUTING COMPANY

216307

GENERAL AIR SERVICE & SUPPLY COMPANY

157 records. Showing 1-40. Next