FDA.reportPublic FDA data

Instrumed International Inc dba Avalign German Specialty Instruments

Matched from indexed company URL: INSTRUMED, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
14211011421101Instrumed International Inc dba Avalign German Specialty Instruments1Y2026-01-01626 Cooper Ct SCHAUMBURG IL US 60173
80103723007290840Instrumed GmbH dba Avalign German Specialty Instruments1N2026-01-013 Unter Buchsteig TUTTLINGEN Baden-Wurttemberg DE 78532

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1985791379539248K990671DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPEHOZ1999-05-10
1985791187932224K982620MEDIVISION CYSTOSCOPEFAJ1998-09-30
1985791282693045K981751SINUSCOPE AND ACCESSORIESEOB1998-08-13
1985791273148713K980002KOALA VASCULAR CLAMPS AND INSERTSDXC1998-06-18
2031831273148713K980002KOALA VASCULAR CLAMPS AND INSERTSDXC1998-06-18
1985791823162843K974793ELMED ESU 120 M/M DIGITALGEI1998-03-19
1985791914180603K974595CUSHING BAYONET, INSULATED BIPOLAR FORCEPHTD1998-06-24
1985791504245230K974594SEMKIN BIPOLAR FORCEPHTD1998-06-24
1985791952199930K974593SEMKIN INSULATED BIPOLAR FORCEPHTD1998-06-24
1985791828195308K974382ACKERMANN SURGICAL INSTRUMENTSGCJ1998-04-21
1985791018326038K972901AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORDGEI1997-09-19
1985791672308456K972661EYE SPHERE, CONFORMERSHPZ1997-10-03
1985791137562200K972225UFR FIBEROPTIC CABLEFST1998-03-18
1985791146026982K971996MEDIVISION ARTHROSCOPHRX1997-07-31
1985791749707038K970968BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPSHET1998-05-21
1985792000083920K964176TECNO REUSABLE, ELECTROSURGICAL, BIPOLAR FORCEPSGEI1997-08-14
1985791905673836K962545DENTAL, MEDICAL INSTRUMENT CASES & CASSETTEKCT1997-03-07
1985791540374134K962075HSW GMBH ARTHROSCOPEHRX1997-01-17
1985791307952424K960347SAFETY TROCER WITH SPRINGLOADED OBDURATORHET1996-07-01
1985791578086684K953889AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORDGEI1995-10-18
1985791407253419K933174GREENWALD FLEXIBLE ENDOSCOPIC ELECTRODEFAS1994-04-01
1985792019651258K933173GREENWALD CONTROL-TIP CYSTOSCOPIC ELECTRODEFAS1994-04-01
1985791727982282K932938ELMED ESU 300 M/M AND DIGITALGEI1994-05-02
1985791283714755K926517ELMED LBC 50-PHIN1994-11-15
1985792029915271K921770ELECTROSURGICAL UNITS ESU 100L, 100 L M/M & E M/MGEI1993-05-17
1985791386124387K915731ELECTROSURGICAL UNITS ESU 30, 70, 70 B, 70 DIGITALGEI1992-11-05
1985791113461328K911160MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305GEI1991-05-02
1985791283357716K902818MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENTHBG1990-09-20
1985791931843554K894303MEDSCOPE 4MM ARTHROSCOPEHRX1989-07-25
1985791797146700K890765STRIP, STERILIZATION INDICATOR; STEAM OR E.O. GASJOJ1989-08-07
1985791780449245K890755SEALING TAPE, STERILIZATION INDICATOR; STEAMJOJ1989-08-07
1985791231258531K832589ELMED WMC 10 AND BC 50 M/M1984-04-23
1985791553864423K820526RELIEF VALVE-HONAN INTRAOC. PRESSURELCC1982-03-25
1985791112063166K193066Steripack cases and Tray SystemsKCT2020-08-06
1985791049584535K181173ELMED Laparoscopic Instruments and AccessoriesGCJ2019-03-22
1985791697481254K172368Bipolar Micro-Coagulation ForcepsGEI2018-04-05
1985791878328528K150468Laminectomy Rongeurs, Kerrison Rongeurs, IVD RongeursHAE2016-02-29
2031831418899657K143752Total Knee Application (TKA)OLO2015-08-06
1985791076180326K130117NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDSHOZ2013-10-29
1985791755111945K123478STINGRAY BIPOLAR FORCEPSGEI2013-05-10
1985791406591799K110121WEXLER ENDOSCOPE ACCESSORIESGCJ2011-05-10
1985791721311183K102752STINGRAY ULTRALITE DISPOSABLE IRRIGATING BIPOLAR FORCEPSGEI2011-11-09
2031831964552027K102429ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREWHRS2010-11-23
1985791043720768K100736KIRSCHNER AND GUIDE WIRESHTY2010-09-10
1985791952665183K100518INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054DWP2010-08-31
1985791993360716K100517INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXXHDA2010-04-29
1985791557001192K092840INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICALHCZ2009-12-03
1985791012492812K092544INSTRUMED VASCULAR CLAMPSDXC2009-10-26
1985791517844125K090763RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEMNPJ2009-06-17
1985791093353612K083796MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHTEJI2009-03-09
1985791648478953K083162STINGRAY ELECTROSURGICAL FORCEPSGEI2009-01-12
1985791562694714K082349JARIT HULKA UTERINE TENACULUM FORCEPSHDC2008-11-21
1985791320912112K082172MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEMHSX2008-11-28
1985791605293233K081651INSTRUMED RONGEURHAE2008-08-08
1985791922484621K071771INSTRUMED RETRACTORSGZT2007-08-02
1985791936174124K061271ERCH ARCH BAR, MODEL 38-690-00DYX2006-06-30
1985791188364868K060233TROKAMED GMBH ENDOSCOPES AND ACCESSORIESGCJ2006-07-19
1985791899199344K040855INSTRUMED LAPAROSCOPE AND ACCESSORIESGEI2004-04-16
1985791505139527K030665BONE WIREHTY2003-03-25
1985791176058828K021859WRIST IMPLANTJWJ2002-12-02
1985791161917271K003717INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE ENDODCOPIC INSTRUMENTS 5 MM, 10MM (HANDLE, SHAFGEI2001-03-01
1985791948302974K001185POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USPGAW2000-06-23
1985791670999639K000297ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGERFHN2000-04-24
1985791345544632H010001
1985791023344195
1985791033327664
1985791043780205
1985791047124692
1985791055319519
1985791072642703
1985791079996744
1985791081784978
1985791082964912
1985791092014903
1985791093543015
1985791096300959
1985791105121881
1985791114635507
1985791124515564
1985791137884588
1985791139732003
1985791147645656
1985791148962317
1985791184911127
1985791185823705
1985791191034518
1985791194915785
1985791205385659
1985791215285525
1985791240687784
1985791250742107
1985791271458632
1985791319349565
1985791321603673
1985791321910902
1985791326064235
1985791374250492
2031831374250492
1985791381950087
1985791387137611
1985791411862032
1985791416263585
1985791448483613
1985791451747605
1985791452153774
1985791455995375
1985791467477245
1985791498600718
1985791528996977
1985791540406101
1985791556278852
1985791571782936
1985791572283282
1985791600061645
1985791611935813
2031831611935813
1985791621079594
1985791633413438
1985791635411167
1985791642509788

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI142018-04-05
GCJ42019-03-22
DXC32009-10-26
HTD31998-06-24
HRX31997-07-31
KCT22020-08-06
HAE22016-02-29
HOZ22013-10-29
HTY22010-09-10
HET21998-05-21
FAS21994-04-01
JOJ21989-08-07
OLO12015-08-06
HRS12010-11-23
DWP12010-08-31
HDA12010-04-29
HCZ12009-12-03
NPJ12009-06-17
EJI12009-03-09
HSX12008-11-28
HDC12008-11-21
GZT12007-08-02
DYX12006-06-30
JWJ12002-12-02
GAW12000-06-23
FHN12000-04-24
FAJ11998-09-30
EOB11998-08-13
FST11998-03-18
HPZ11997-10-03
HIN11994-11-15
HBG11990-09-20
LCC11982-03-25

PMN#