FDA.reportPublic FDA data

ASPEN

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18361613002750084ASPEN SURGICAL PRODUCTS, INC.1Y2026-01-016945 SOUTHBELT DR. S.E. Caledonia MI US 49316
20307753000206792ASPEN MEDICAL PRODUCTS, LLC1Y2026-01-016481 OAK CANYON IRVINE CA US 92618
26497982649798Aspen Surgical Puerto Rico Corp.1N2026-01-01RD. 183, KM. 20.3 Colinas de San Agustin PR US 00771
30045185013004518501ASPEN SEATING, LLC1N2026-01-018100 SouthPark Way, C400 Littleton CO US 80120
30103247783010324778ASPEN MEDICAL SYSTEMS, CORP.1Y2026-01-01351 Tulipan St Lomas de la Serania Caguas PR US 00725
30113878163011387816ASPEN LASER SYSTEMS, LLC1Y2026-01-01175 N 1800 W Ste 108 Lindon UT US 84042
30126248173012624817ASPEN IMAGING HEALTHCARE, INC1N2026-01-01801 north Jupiter rd 200 Plano TX US 75074
30210746433021074643Aspen Surgical Products, Inc.1Y2026-01-01300 East 1st St Douglas AZ US 85607
30429534973042953497ASPEN BUSINESS SOLUTIONS LLC1Y2026-01-01852 E 3350 N North Ogden UT US 84414
30113878163011387816ASPEN LASER SYSTEMS, LLC1Y2020-04-251290 SW Biltmore Street Suite A Port Saint Lucie FL US 34983

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
00841785107160Symmetry Olsen - Insulated Pott-Smith Forceps 8" (20.3cm) Serrated 1.5mm Tips, Exposed Top1 888-364-7004customerservice@aspensurgical.com
00841785107177Symmetry Olsen - Insulated Pott-Smith Forceps 8" (20.3cm) Serrated 1.0mm Tips, Exposed Top1 888-364-7004customerservice@aspensurgical.com
00841785107191Symmetry Olsen - Insulated Pott-Smith Forceps 10" (25.4cm) Serrated 2.0mm Tips1 888-364-7004customerservice@aspensurgical.com
00841785107269Symmetry Olsen - Insulated Pott-Smith Forceps 9.75" (24.8cm) Serrated 2.0mm Tips, Exposed Top1 888-364-7004customerservice@aspensurgical.com
00841785107276Symmetry Olsen - Insulated Pott-Smith Forceps 9.75" (24.8cm) Serrated 1.5mm Tips, Exposed Top1 888-364-7004customerservice@aspensurgical.com
00841785107481Symmetry Olsen - Insulated DeBakey Forceps 9.5" (24.1cm) Serrated 2.0mm Tips, Exposed Top1 888-364-7004customerservice@aspensurgical.com
00841785107504Symmetry Olsen - Insulated DeBakey Forceps 7.75" (19.7cm) Serrated 2.0mm Tips, Exposed Top1 888-364-7004customerservice@aspensurgical.com
00841785107528Symmetry Olsen - Insulated Pott-Smith Forceps 10" (25.4cm) Serrated 1.5mm Tips, Exposed Top1 888-364-7004customerservice@aspensurgical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2339631328946461K993535METAPAK MULTI-PURPOSE INSTRUMENT TRAYFRG2001-12-07
2339631133803933K990785TROCAR & TROCAR SLEEVES, LAPAROSCOPES, LAPAROSCOPIC FORCEPS, & LAPAROSCOPIC INSTRUMENTSGCJ1999-08-27
2339631229384684K984352AARON TOP50 REUSABLE ELECTROSURGICAL PENCIL, MODEL #ESPRGEI1999-03-04
2339631986960207K984239SLICKTIP SOLID LAPAROSCOPIC ELECTRODE, MODELS LH01Z, LB02Z, LN03Z, LC04Z, LS05Z, LL06Z, LJ07ZGEI1999-02-10
2339631046265821K984236AARON ESU FOOT-CONTROL ADAPTER #A1205AGEI1999-02-10
2339631468512221K982705MIDAS TOUCH BIPOLAR FORCEPSGEI1998-09-08
2339631488842748K982428CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT)HET1998-10-09
2339631117741557K982365ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMATDXC1999-04-08
2339631784252866K981614NON-STERILE HOLSTER, STERILE HOLSTER MODEL ESH1-NS, ESH1, ES PENCIL W/ HOLSTER, ES SMOKE & FLUID PENCIL W/ HOLSTER MODELGEI1998-07-17
2339631233772986K980366AARON 1200 HIGH FREQUENCY ELECTROSURGICL GENERATOR A1200, A1200/240GEI1998-02-27
2339631022700685K974595CUSHING BAYONET, INSULATED BIPOLAR FORCEPHTD1998-06-24
2339631361158607K974594SEMKIN BIPOLAR FORCEPHTD1998-06-24
2339631172702489K974593SEMKIN INSULATED BIPOLAR FORCEPHTD1998-06-24
2339631517047217K974382ACKERMANN SURGICAL INSTRUMENTSGCJ1998-04-21
2339631126392396K973958GENERAL PURPOSE ATL NEEDLE GUIDE KITITX1998-01-22
2339631418224526K973234MIDAS TOUCH ELECTROSURGICAL ELECTRODEGEI1997-10-27
2339631347178749K971805ELECTROSURGICAL TIP CLEANER, TIP CLEANING PAD, LECTROBRASIVE TIP CLEANER, ELECTROSURGICAL TIP CLEANER, ELECTRODE TIP CLEGEI1997-06-13
2339631310251939K971674VALLEYLAB SINGLE USE SOLID LAPAROSCOPIC ELEC. SPATULA (STRAIGHT & CURVED) J&L HOOK, BALL CONMED SOLID SHAFT ELECTRODE STGEI1997-06-11
2339631545312293K970893ULTRASOUND TRANSDUCER DRAPEFYA1997-10-20
2339631771243573K970891DRAPE, SURGICAL-LATEXKKX1997-08-22
2339631064973267K970889ULTRASOUND TRANSDUCER DRAPEKKX1997-10-20
2339631112152301K970885ULTRASOUND SYSTEMS DRAPEMMP1997-09-22
2339631752249212K962545DENTAL, MEDICAL INSTRUMENT CASES & CASSETTEKCT1997-03-07
2339631889511937K961074LIGHTSOURCE OR ILLUMINATORFSS1996-04-30
2339631320536703K955681AARON 800 HIGH FREQUENCY DESICCATOR/HANDPIECEGEI1996-02-08
2339631053526000K954699BRAY RONGEURHAE1995-12-06
2339631804053589K951736LOCK-UPFMI1995-07-05
2339631701043548K950520BURR, CORNEAL, BATTERY-POWEREDHOG1995-05-02
2339631324221540K946263BRIMFIELD PRECISION GRASPER/DISSECTORGCJ1995-01-26
2339631742554325K945763LOW TEMPERATURE CAUTERY ELONGATED FINE TIPHQP1995-02-07
2339631570394279K945762LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLEHQP1995-02-07
2339631212418357K945759HIGH TEMPERATURE CAUTERY 5 LOOPGEI1995-01-30
2339631411089689K945758HI-TIP HIGH TEMPERATURE REPLACEMENT TIPGEI1995-04-21
2339631712601914K945757HIGH TEMPERATURE CAUTERY FINE ADJUSTABLEGEI1995-01-30
2339631282599011K945493OPHTHALMIC CAUTERYHQP1995-01-30
2339631287624019K945492HIGH TEMPERATURE CAUTERYGEI1995-01-30
2339631154144100K944055FORCEPS, SURGICAL GYNECOLOGICALHCZ1994-09-20
2339631894868692K942986ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP)HGI1995-03-21
2339631717764975K940718INNERVISION INC. LAPAROSCOPIC HAND INSTRUMENTSHET1994-07-22
2339631391775782K940552MONOPOLAR SURGICAL INSTRUMENTSGEI1994-05-05
2339631835904470K940551ENDOSCOPIC SURGICAL INSTRUMENTSGCJ1994-04-29
2339631356427491K936304ELECTROSURGICAL PENCILGEI1994-06-13
2339631696764276K935755THE ULTRAKCT1995-05-05
2339631558347448K934969DUALGARD FACE SHIELDFXX1994-03-28
2339631656622702K932449DR. FOGOCT1993-08-11
2339631070138677K93133816 ELECTRODES (BLADE, BALL, NEEDLE & LOOP)HGI1994-02-16
2339631928143064K930041VICROSAFE 6 AND VICROSAFE 12FYD1993-11-03
2339631117691992K925114LAPAROSCOPIC INSTRUMENTSHFI1994-02-28
2339631010105759K925079LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER)HET1994-08-24
2339631932725652K924732PORTA PLUMESAFE(TM) 601 SMOKE EVACUATION SYSTEMFYD1993-09-13
2339631809222128K922154INSULATED SPECULUM W/ SMOKE EVACUATOR OPTIONHIB1994-04-21
2339631434031387K913623SURGICAL ELECTRICAL PENCILGEI1992-02-21
2339632003639851K913500CHERRY SPONGEGCJ1991-09-25
2339632020477035K913108TEFLON COATED ELECTRODES/ELECTRODES HANDLESGEI1991-12-23
2339631553934621K912367EYE BUBBLEHOY1991-10-02
2339631691020539K905045NERVE LOCATOR/STIMULATORETN1991-03-15
2339631152106256K891409PRECEPT MICRO-GARD LASER MASKFXX1989-04-07
2339631069989990K890763LABEL, STERILIZATION INDICATOR; DUAL STEAM/E.O.GASJOJ1989-08-07
2339631665106908K885200600 & 900 SERIES ELECTRODES & 755 & 756 HANDLEGEI1989-01-13
2339632019653288K884656DISPOSABLE BIPOLAR CORD AND BIPOLAR FORCEPGEI1988-11-25
2339631262517501K884175#820/821 BIPOLAR FORCEPSHAM1988-10-24
2339631692346760K884174MODIFIED OLSEN 755/756 SWITCHPENSHAM1988-10-24
2339631178314809K884173#920 DISPOSABLE TUR CABLEHAM1988-10-24
2339631640383804K884172MODIFIED OLSEN #770 DISPOSABLE HOLSTERHAM1988-10-24
2339631321608937K884171#875 DISPOSABLE BIOPOLAR CABLEHAM1988-10-24
2339631136645668K882071CRANK FRAME RETRACTORGZT1988-06-10
2339631675015693K874813OMED WOUND CLOSURE STRIPSFPX1988-01-29
2339631031653589K871910SURGITEK DISPOSABLE BIPOLAR CORDGEI1987-06-01
2339631488644846K871202FLASHPAK CONTAINER SYSTEMFRG1987-05-29
2339631897175298K852404LASERSAFE EYE SHIELDSHOY1985-10-04
2339631719774842K840434REPLACE-A-TIP LOW TEMP. CAUTERYGEI1984-04-25
2339631877248891K840433REPLACE-A-TIP HIGH TEMP. CAUTERYGEI1984-04-25
2339631378970667K840373FLEXIBLE ILLUMINATOR 10FTF1984-04-24
2339631773360810K834329OLSEN 756 ROCKER SWITCHPENGEI1984-04-04
2339631799493911K802972DUAL-TROLGEI1981-01-15
2339631920016167K781548UMBILICAL CORD CLAMPHFW1978-10-17
2339631600295604K771409DISP. SURGICAL FACE MASKFXX1977-10-27
2339631445878900K770463MASK, SURGICAL, FACE, DISPOSABLEFXX1977-03-23
2822531257973357K244049Europa (Alternative: AiRTouch) portable X-ray systemIZL2025-05-28
2822531301860630K241346IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)MQB2024-11-07
2822531874747640K220678APX-24 Portable X-ray SystemIZL2022-03-31
2822531690370201K200022FLUSION-9001, Fluoroscopic C-arm Mobile X-ray SystemOWB2020-04-03
2822531804221151K193644E-COM DR-2000 DRMQB2020-02-14
2339631416292250K181887AMD Anti-Fog SolutionOCT2019-01-22
2822531784473560K180663LaVid FMTS DIAGNOSTIC X-RAY SYSTEMKPR2018-05-18
2339631480423717K161744Symmetry Sharp Kerrison RongeurHAE2016-09-07
2339631038051940K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-AspiratingGEI2016-07-29
2339631671977476K161134Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical GeneratorGEI2016-06-20
2339631898366624K161004Self-retaining RetractorGZT2016-09-09
2339631367354945K152777Bovie Disposable Bipolar AblatorGEI2016-01-15
2339631803537244K152082Vesocclude Polymer Ligating ClipFZP2016-02-26
1786401464482733K150138Aspen Laser Systems Therapy Laser SystemPDZ2015-05-08
2339631258643289K142975Bovie Ultimate High Frequency Electrosurgical GeneratorGEI2014-12-12
2339631314129860K142903neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack USGCJ2014-11-12
2339631983521292K142700InsufflatOR NeedleHIF2014-12-19
2339631041163681K142229Laparoscopic FMsealerGEI2015-01-02
1786401619534813K142078VELASII THERAPY LASER SYSTEMILY2014-10-30
3370631619534813K142078VELASII THERAPY LASER SYSTEMILY2014-10-30
2339631686575171K141484OPEN FMSEALERGEI2014-07-30
2339631768461220K134054BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH FREQUENCY ELECTROSURGICAL GENERATORGEI2014-03-17
2339631101519008K131402VISICLEAR SMOKE EVACUATION SYSTEMFYD2014-03-03
2339631855208643K130669SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPSGEI2013-12-06
2339631886759172K130606FMWAND FERROMAGNETIC SURGICAL SYSTEMHGI2014-01-03
2339631782732404K130541SYMMETRY KERRISON DISPOSABLE TIP RONGEURSHAE2013-08-05
2339631903002813K123234ERMIS STERILIZATION CONTAINER SYSTEMKCT2013-07-05
2339631600816018K121441CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)HQP2012-07-20
2339631464550321K120117CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEMKCT2012-04-16
2339632033966981K113776FLASHPAKFRG2012-08-08
2339631366934483K113080TUBALGATORHIN2012-06-29
2339631607359831K111262ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOPGEI2012-05-23
2339631090175413K110439DOMAIN SURGICAL SYSTEMGEI2011-07-18
2339631896515967K110152SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORSJOJ2011-04-15
2339631640797383K101653MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTESKCT2010-08-02
2339631653876027K100518INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054DWP2010-08-31
2339632010213058K100517INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXXHDA2010-04-29
2339631857577299K093025BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODESGEI2009-12-22
2339631809662909K092840INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICALHCZ2009-12-03
2339631740974980K092544INSTRUMED VASCULAR CLAMPSDXC2009-10-26

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI562016-07-29
KCT92013-07-05
GCJ72014-11-12
HAM51988-10-24
HAE42016-09-07
FYD42014-03-03
HQP42012-07-20
FXX41994-03-28
IZL32025-05-28
GZT32016-09-09
HGI32014-01-03
FRG32012-08-08
HET31998-10-09
HTD31998-06-24
MQB22024-11-07
OWB22020-04-03
OCT22019-01-22
ILY22014-10-30
JOJ22011-04-15
DWP22010-08-31
HCZ22009-12-03
DXC22009-10-26
KKX21997-10-20
HOY21991-10-02
KPR12018-05-18
FZP12016-02-26
PDZ12015-05-08
HIF12014-12-19
HIN12012-06-29
HDA12010-04-29
HEW12005-09-02
HBO12004-01-07
MLY12003-08-20
FTA12002-02-14
HCH12001-05-30
FRO12001-03-27
ITX11998-01-22
FYA11997-10-20
MMP11997-09-22
FSS11996-04-30

NDC#

OXYGEN

Aspen Air U.S., LLC

OXYGEN

PMN#

AspenView

2025-02-12

Aspen Imaging Healthcare, Inc.

4000 ETM

1996-02-20

ASPEN LABORATORIES, INC.

73 records. Showing 1-40. Next

Applications#

GUDID#

80 records. Showing 1-40. Next