FDA.reportPublic FDA data

GYRUS ACMI, INC.

Matched from indexed company URL: Gyrus ACMI, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10370071037007GYRUS ACMI, INC.1N2026-01-012925 Appling Rd BARTLETT TN US 38133
30037903043003790304GYRUS ACMI, INC.1N2026-01-01800 West Park Drive Westborough MA US 01581
30044509983004450998Gyrus ACMI, Inc.1N2026-01-016675 185th Avenue NE Redmond WA US 98052
30110505703011050570Gyrus ACMI, Inc.1N2026-01-019600 Louisiana Ave North Brooklyn Park MN US 55445
15191321519132GYRUS ACMI, INC.1N2020-04-2593 NORTH PLEASANT ST. Norwalk OH US 44857
30059754943011050570GYRUS ACMI L.P.1Y2020-04-259600 Louisiana Avenue North Brooklyn Park MN US 55445

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1732011773606456P870076FALOPE RING BAND AND APPLICATOR SYSTEMSKNH1993-09-29
850981477766133P180007Spiration® Valve SystemNJK2018-12-03
1203821477766133P180007Spiration® Valve SystemNJK2018-12-03
1732011957900258K994418VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)HIH2000-01-24
1732011285971246K993041OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENTFAJ2000-03-30
850151755527353K992994TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS;ERL1999-11-23
850981755527353K992994TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS;ERL1999-11-23
1732011755527353K992994TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS;ERL1999-11-23
1732011988984750K992901GYNECARE VERSAPOINT G-VAP ELECTRODEHIH2000-01-18
850151728227679K992222FLUOROPLASTIC VENTILATION TUBESETD1999-08-26
850152035633332K992222FLUOROPLASTIC VENTILATION TUBESETD1999-08-26
850332035633332K992222FLUOROPLASTIC VENTILATION TUBESETD1999-08-26
850982035633332K992222FLUOROPLASTIC VENTILATION TUBESETD1999-08-26
1732012035633332K992222FLUOROPLASTIC VENTILATION TUBESETD1999-08-26
850981240002712K992126CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEMGCX1999-08-03
850981052141989K990628GYRUS ENDOUROLOGY SYSTEMKNS1999-06-29
1732011052141989K990628GYRUS ENDOUROLOGY SYSTEMKNS1999-06-29
850151500763314K990601BOJRAB MICRO-TORP, MODEL 7014-5845ETA1999-03-31
1732011802125887K984255OLYMPUS HX-20 SERIES LIGATING DEVICEMND1999-01-12
850151513276957K983276HYDROFERA BACTERISTATIC NASAL DRESSINGEMX1999-09-14
1732011513276957K983276HYDROFERA BACTERISTATIC NASAL DRESSINGEMX1999-09-14
1732011144881466K982738VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)HIH1999-03-01
1732011496990229K982734OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USEODG1998-10-05
1732011914812568K982733OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USEITX1998-10-28
850151909523625K982717SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200GEI1998-11-02
850981909523625K982717SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200GEI1998-11-02
1732011909523625K982717SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200GEI1998-11-02
1732011059774671K982289HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##KNS1998-08-19
1732011067586029K981993OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHAODA1998-08-21
850331891387699K980972RIGID CULDOSCOPE AND ACCESSORIESHEW1998-06-12
850981891387699K980972RIGID CULDOSCOPE AND ACCESSORIESHEW1998-06-12
1732011891387699K980972RIGID CULDOSCOPE AND ACCESSORIESHEW1998-06-12
850331462218893K980492AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)FFK1998-11-17
850981462218893K980492AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)FFK1998-11-17
1732011462218893K980492AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)FFK1998-11-17
1431341671352102K980366AARON 1200 HIGH FREQUENCY ELECTROSURGICL GENERATOR A1200, A1200/240GEI1998-02-27
1732011671352102K980366AARON 1200 HIGH FREQUENCY ELECTROSURGICL GENERATOR A1200, A1200/240GEI1998-02-27
850151225139473K974311VOCOM (VOCAL CORD MEDIALIZATION) IMPLANTKHJ1998-03-04
850981225139473K974311VOCOM (VOCAL CORD MEDIALIZATION) IMPLANTKHJ1998-03-04
1732011225139473K974311VOCOM (VOCAL CORD MEDIALIZATION) IMPLANTKHJ1998-03-04
850151978641833K974232ESSENTIAL SHAVER SYSTEMEQJ1998-01-12
850981494255120K973820USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODEFAS1998-05-12
1732011494255120K973820USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODEFAS1998-05-12
850151979819349K973701SOMNUS TISSUE COAGULATING ELECTRODEGEI1998-01-30
850981979819349K973701SOMNUS TISSUE COAGULATING ELECTRODEGEI1998-01-30
1732011979819349K973701SOMNUS TISSUE COAGULATING ELECTRODEGEI1998-01-30
850151823347142K973618SOMNOPLASTY SYSTEMGEI1997-12-19
850981823347142K973618SOMNOPLASTY SYSTEMGEI1997-12-19
1732011823347142K973618SOMNOPLASTY SYSTEMGEI1997-12-19
850151193999555K973286ENT IRRIGATING PUMP (70327700)ERL1997-09-29
850151283824519K973286ENT IRRIGATING PUMP (70327700)ERL1997-09-29
1732011799678910K971881COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORSFJL1997-08-12
850151898166342K971450SOMNOPLASTY SYSTEMGEI1997-07-17
850981898166342K971450SOMNOPLASTY SYSTEMGEI1997-07-17
1732011898166342K971450SOMNOPLASTY SYSTEMGEI1997-07-17
1732011401757430K971166OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECEEWY1997-08-27
850151292472064K970809BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOLGEI1997-06-18
850981292472064K970809BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOLGEI1997-06-18
1732011292472064K970809BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOLGEI1997-06-18
850151781680477K964334EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT)GCJ1996-12-09
1732011036958696K963184OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEMGCJ1996-12-31
1732012020378066K963033
850151499294905K962564RICHARDS TOTAL/PARTIAL PROSTHESISETB1997-01-22
850151792049960K962564RICHARDS TOTAL/PARTIAL PROSTHESISETB1997-01-22
1732011604646543K962555OLYMPUS FB SERIES BIOPSY FORCEPSEOQ1996-07-30
1732011034547630K962533OLYPUS FG SERIES GRASPING FORCEPSEOQ1996-08-09
1732011246031844K962485OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT)EOQ1996-08-20
1732011467102918K962482SCUBA SYSTEMHIH1996-11-01
850151725287163K960477VENTILATION TUBESETD1996-02-26
850981725287163K960477VENTILATION TUBESETD1996-02-26
1732011725287163K960477VENTILATION TUBESETD1996-02-26
850981514778182K960148CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENTFAD1996-03-25
1732011514778182K960148CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENTFAD1996-03-25
850151387235042K955593EXPANDACELL ANATOMICAL POSTERIOR NASAL PACK W/& WITHOUT AIRWAYEMX1995-12-22
1732011618400520K955403OES LAPARO-THORACO VIDEOSCOPE TYPE VHET1996-03-11
1732011143645266K955065OLYMPUS FB SERIES BIOPSY FORCEPSFCL1996-01-24
850981168939218K954824PROTECTOR RETRACTOR & PROTECTOR RETRACTOR WITH DRAPEKKX1996-04-23
850151379353051K953096ESSENTIAL SHAVER SYSTEMEQJ1995-07-28
1732011379353051K953096ESSENTIAL SHAVER SYSTEMEQJ1995-07-28
850151826815887K953096ESSENTIAL SHAVER SYSTEMEQJ1995-07-28
1732011738942144K952892OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908)ITX1996-02-12
850151548500840K952481RICHARDS PORPETB1995-06-16
850331695974454K951972CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHSFBO1995-07-21
850981695974454K951972CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHSFBO1995-07-21
1732011695974454K951972CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHSFBO1995-07-21
1732011669732498K951445OLYMPUS FD-5 HOT BIOPSY FORCEPSKGE1995-05-03
1732011245740833K951354OLYMPUS ARTHROSCOPY SYSTEMHRX1995-06-14
850151368225400K950984HAPES MALLEABLE INCUS STAPESETB1995-03-15
850151833934085K950984HAPES MALLEABLE INCUS STAPESETB1995-03-15
850151914640358K950927HAPEX MALLEABLE TORPETA1995-03-21
850151041541183K950887HAPEX INCUSETB1995-03-15
850151576783814K950886HAPEX PORPETB1995-03-15
850151078789995K950885HAPEX MALLEABLE PORPETB1995-03-15
1732011635909837K950455DEVICE, ELECTROSURGICAL, CUTTING AND COAGULATION & ACCESSORIESJOS1995-05-16
850151602516694K950024EXPANDACELL NASAL PACK WITH AIRWAYEMX1995-02-17
850981887842183K946296QUADRA-COIL URETERAL STENTFAD1995-03-06
1732011887842183K946296QUADRA-COIL URETERAL STENTFAD1995-03-06
850981587443115K945758HI-TIP HIGH TEMPERATURE REPLACEMENT TIPGEI1995-04-21
1732011587443115K945758HI-TIP HIGH TEMPERATURE REPLACEMENT TIPGEI1995-04-21
850331830199273K945266OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPESGCJ1995-02-23
1431341741129826K945262OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPESFAJ1995-05-26
1732011741129826K945262OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPESFAJ1995-05-26
1732011053974471K944912OLYMPUS NBD TUBESFGE1995-06-13
850331158805325K944025SURGICAL INSTRUMENT TRAYFSM1994-11-22
850981158805325K944025SURGICAL INSTRUMENT TRAYFSM1994-11-22
1732011158805325K944025SURGICAL INSTRUMENT TRAYFSM1994-11-22
1732011556216498K942986ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP)HGI1995-03-21
1732011064769980K942338OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIESFDT1994-11-30
850981300088907K941952SURGITEK INFUSERFAD1994-05-24
1431341300088907K941952SURGITEK INFUSERFAD1994-05-24
850981044947072K941743CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMPHIG1995-04-19
1732011044947072K941743CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMPHIG1995-04-19
850151513777859K940133THE EXPANDACELL EAR PACKLRD1994-05-23
1732011306126453K936304ELECTROSURGICAL PENCILGEI1994-06-13
850151776145409K936048LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND)FST1994-03-10
1732011776145409K936048LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND)FST1994-03-10
1732011336601073K935947HI-TOPS ELECTRODES 14-8000KNF1994-02-28
850151442532658K935724THE EXPANDACELL SINUS PACKEMX1994-05-12
850151010337060K935235ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERYGCM1995-03-23
850981010337060K935235ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERYGCM1995-03-23

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI1112026-03-02
ETB462000-10-31
ETD292000-06-19
FAD201996-03-25
GCJ192022-03-09
ERL182022-01-19
FGB152018-03-29
FFK152013-11-26
ETA152000-08-29
HIH132004-03-09
EOB92016-01-15
KNS92012-12-14
EOQ82021-02-19
FEO82017-08-21
FAJ82004-09-10
FAS72010-02-24
KTI62020-03-18
HIG62002-01-08
EMX61999-09-14
KCT52021-09-15
FGE52018-03-08
FDC52002-05-09
FBK52001-08-10
GEX42024-08-23
HHI42017-09-29
HIN42014-11-21
KNY42013-02-04
EYB42005-03-03
ITX42001-05-15
EQJ41998-01-12
LYA32018-11-30
FBN32010-03-10
HET32008-09-26
OCU32003-06-03
HAW32003-05-02
KOB32001-09-19
MIX32000-03-01
HEW31998-06-12
KHJ31998-03-04
FBO31995-07-21

PMA#

SVS Deployment Catheter and Loader

2022-05-12

Gyrus ACMI, Inc.6675 185th Avenue Neredmond, WA 98052 PMA NumberP180007 Supplement NumberS009 Date Received04/12/2022 Decision Date05/12/2022 Product Code NJK  Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change -...

PMN#

PK AIM

2017-05-19

Gyrus ACMI Inc.

PK AIM

2016-12-12

Gyrus ACMI Inc.

PK AIM

2016-09-26

GYRUS ACMI INC.

PK AIM

2015-12-17

GYRUS ACMI INC

DTAD

2012-08-30

GYRUS ACMI, INC.

42 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next