FDA.reportPublic FDA data

Brian Cousins

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96116653002807095Brian Cousins1N2026-01-012015 Spring Road Suite 650 Oak Brook IL US 60523
96165173003117688Brian Cousins1N2026-01-012015 Spring Road Suite 650 Oak Brook IL US 60523
30046815193003870583Brian Cousins1N2026-01-012015 Spring Road Suite 650 Oak Brook IL US 60523
30059144903005914490Brian Cousins1N2026-01-012015 Spring Road Suite 650 Oak Brook IL US 60523
30059417193002807111Brian Cousins1N2026-01-012015 Spring Road Suite 650 Oak Brook IL US 60523
30064050733006405073Brian Cousins1N2026-01-012015 Spring Road Suite 650 Oak Brook IL US 60523
30070077903007007790Brian Cousins1N2026-01-012015 Spring Road Suite 650 Oak Brook IL US 60523
30081323983002807091Brian Cousins1N2026-01-012015 Spring Road Suite 650 Oak Brook IL US 60523
30081324113008132411Brian Cousins1N2026-01-012015 Spring Road Suite 650 Oak Brook IL US 60523
30083286793008328679Brian Cousins1N2026-01-012015 Spring Road Suite 650 Oak Brook IL US 60523
30103706503010165944Brian Cousins1N2026-01-012015 Spring Road Suite 650 Oak Brook IL US 60523
30104072033010407203Brian Cousins1N2026-01-012015 Spring Road Suite 650 Oak Brook IL US 60523
30104328903010432890Brian Cousins1N2026-01-012015 Spring Road Suite 650 Oak Brook IL US 60523
30081459873008145987Brian Cousins1N2020-04-254341 STATE STREET RD SKANEATELES FALLS NY US 13153
30108592573010859257Brian Cousins1N2020-04-254341 STATE STREET RD SKANEATELES FALLS NY US 13153

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1107441534383082K993975ABSOLUTE ABSORBABLE INTERFERENCE SCREWHWC1999-12-20
1107701003985454K993629ABI VEST AIRWAY CLEARANCE SYSTEMBYI2000-01-21
1887521172660720K993161COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEMJTW1999-11-09
1107441016502451K992611MITEK ROTATOR CUFF QUICKANCHOR PLUSHWC1999-09-22
1107031732334390K992091PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750FMI1999-09-09
1107441815313081K990454BIO-INTERFERENCE SCREWHWC1999-07-01
1107441409787406K983818MITEK FASTIN RC ANCHORMBI1998-11-23
1107441376594924K983560INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENERMBI1999-01-28
1107441604076299K974341MITEK BTB ABSORBABLE (PLA) CROSS PINHTY1998-04-16
1107031204817768K963748BIO-PLEXUS DROP-IT NEEDLE HOLDERFMI1997-06-06
1107031575157039K961251PUNCTUR-GUARD WINGED SETFMI1996-06-27
1107031745216658K960933BIO-PLEXUS NEEDLE DISPOSAL CONTAINERFMI1996-08-28
1107441469434431K952687PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEMMAI1996-02-06
1887521448908797K946287COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOALJSM1995-03-10
1887521573523092K946284COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOALJSM1995-03-10
1107441687836498K933084CHECK VALVE (FITTING)DTL1994-03-23
1107441178522725K930893MITEK SUPER QUICKANCHOR, MODIFICATIONJDR1993-12-08
1107441795593743K915889MITEK BONE ANCHOR, MODIFICATIONJDR1992-10-22
1107031474198201K895024PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLEFMI1990-09-21
1106981777218943K864264TRICOTEX WOUND CONTACT LAYER DRESSINGNAB1986-12-29
1107681077237141K862364NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)HEM1986-08-19
1107701767516204K192143Maximus SystemNHJ2020-02-14
1107441949164311K173879MiniMed Mio Advance infusion setFPA2018-03-05
1107702014225634K163378Monarch Airway Clearance SystemBYI2017-03-17
1107441812420246K162812Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion SetFPA2017-11-01
1643141244848410K162097InTRAkitDYB2016-11-17
1643141562681748K162027TRAcelet Compression DeviceDXC2016-10-21
1107441720657502K161939Avance Abdominal Dressing KitOXJ2016-11-17
1107442032294676K161797Avance Tubing, Avance Y-Connector, Avance ViewPadOMP2016-10-19
1106981059383321K161038PK MorcellatorGEI2016-10-07
1107441738418309K160591D.O.R.C. Disposable Cryo ProbeHRN2017-01-23
1107361244024383K153694Icare ic100HKY2016-04-19
1107701639053740K151689MetaNeb 4 SystemNHJ2016-03-17
1107011288709232K150151SmartGownTM surgical gownFYA2015-05-21
1887521684508224K143142JDENTALCARE Implant SystemDZE2015-11-06
1107441351545301K142877EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector)HQC2015-03-13
1107701038792434K142482The Vest Airway Clearance SystemBYI2015-05-07
1107441728774094K132829QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORSDTZ2013-10-08
1107701023110398K124032METANEBNHJ2013-04-25
1107441681927178K123892MEPILEX TRANSFER AGFRO2013-04-05
1107441429772935K1221236-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPEREDMBI2012-10-02
1107441860528929K120589MILAGRO INTERFERENCE SCREWSMAI2012-04-24
1107441556394625K120449HEALIX ADVANCE PEEK ANCHORHWC2012-05-11
1107701703038559K120277VITAL COUGHNHJ2012-09-12
1107442000409835K120078HEALIX ADVANCE BR ANCHORMAI2012-02-29
1107441336246362K113534HEALIX KNOTLESS ANCHORMAI2011-12-20
1107441358636740K112249HEALIX KNOTLESS(TM) ANCHORMAI2011-10-25
1107441374862289K103831DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809MAI2011-07-21
1107441091776359K103712GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORDHWC2011-03-11
1107441994664354K102298TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND PEEK ANCHOR W/ORTHOCORD, HEALIX TRANSTENDHWC2011-01-07
1107011187483411K101359INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML)FMF2010-08-20
1107441686264188K101285CONSTELLATION VISION SYSTEMHQC2010-11-12
1107441725929866K100532VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819HWC2010-03-17
1107012047634880K100302MEDLINE PVC URETHRAL CATHETEREZD2010-07-02
1107442068008613K092836OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL REPAIR SYSTEM/12 DEGREE, MODEL 228141MBI2010-02-04
1107441793783718K091041RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) CROSS PIN KITSMAI2009-08-07
1107441012606987K090515ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)KFM2009-12-18
1107441804056579K090147BLOOD MONITORING UNIT, MODEL BMU 40DRY2009-04-22
1107441208872418K090124GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORTHOCORD, MODEL 210813,210814MAI2009-03-11
1107011030429337K083851INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022LHI2009-05-15
1107442023297350K082282HEALIX TI ANCHORHWC2008-11-07
1107441122742940K080918DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0NEW2008-04-23
1107441259427666K080352MICRO QA+ ANCHOR WITHT #3-0 ORTHOCORD SUTURE, MODEL 212843, MICROFIX AQ+ ANCHOR WITH #3-0 ORTHOCORD SUTUREHWC2008-03-12
1106981775642663K080093PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PKGEI2008-05-02
1107441195948238K073412GRYPHON BR AND HEALIX BR ANCHORSMAI2008-01-17
1107441708598737K071481HEALIX ANCHORHWC2007-08-09
1107441343658885K071257MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORDJDR2007-06-29
1107441687515272K070925MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHORMAI2007-05-02
1107442039521863K063577FEMORAL INTRAFIX SCREW AND SHEATHMBI2007-01-25
1107441201337184K063478VERSALOK ANCHOR WITH FREE STRANDS OF ORTHOCORD SUTURE (210808), ETHIBOND SUTURE (210809), AND PANACRYL SUTURE (210810)HWC2006-12-15
1107441273250498K063273PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHORJDR2006-11-22
1107441328943433K062170BIOKNOTLESS AND LUPINE PLUS ANCHORSJDR2006-08-22
1107441468460635K060830MILAGRO INTERFERENCE SCREWHWC2006-06-15
1107441688365869K060664FASTIN RC ANCHORHWC2006-06-06
1107441128721459K060553RC LOOP /DUAL ORTHOCORD SUTURE,RC LOOP W/ETHIBOND SUTURE,RC LOOP W/PANACRYL SUTUREJDR2006-05-04
1107441925262895K060487LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEMFGE2006-03-23
1107442008004527K053404LIFESTENT FLEXSTART BILIARY STENT SYSTEMFGE2005-12-21
1107441823490683K052631SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)JDR2005-10-21
1107442004198795K052630ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)HWC2005-10-17
1107441023751697K051989GII QUICKANCHOR PLUS WITH ORTHOCORD SUTUREJDR2005-08-05
1107701069915598K051964POWERNEBNHJ2005-12-01
1107031629400661K041410PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118FPA2004-07-28
1107441432782363K041075FASTIN RC ANCHORHWC2004-11-09
1107441269676430K040827PANALOK LOOP ANCHORMAI2004-04-30
1107441039545036K040014PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLYJOH2004-02-13
1107441940327158K032167BIO-INTRAFIX TIBIAL SCREW AND SHEATHHWC2003-10-15
1107441955430573K030995MINILOK QUICKANCHOR PLUSHWC2003-06-26
1107701457070830K024309THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104BYI2003-02-21
1107441358380989K024115MICROFIX QUICKANCHOR PLUSHWC2003-03-13
1107441006689184K023388MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEMJDR2002-12-27
1107441738216885K013781RIDIDFIX 2.7MM BTB CROSS PIN KITHTY2002-02-06
1107442002856507K013572MITEK BIOCRYL INTERFERENCE SCREWSHWC2002-03-14
1107441427650105K010633RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEMHWC2001-05-09
1107031191945302K003827PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTIONFMI2001-01-08
1107441682768668K002639BIOKNOTLESS ANCHORGAM2001-05-11
1107441654256792K002406MITEK 2GII MENISCAL REPAIR SYSTEMMAI2001-02-15
1887521675544436K001780COPAN VIRAL TRANSYSTEMJSM2001-07-31
1107441808601785BK110022
1107441611726912BK090037
1884211122290194
1107011160775446
1107441161978136
1887521355350404
1107441395772783
1887521660537641
1107441904509967
1107441936960724
1643141000023282
1107681000183883
1107011000271196
1643141001761921
1107441003971914
1107441004720915
1107441005312215
1107681005601670
1107011008019912
2004641008099469
1107441008973490
1107681008973490
1106981013364298

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HWC202012-05-11
MAI122012-04-24
JDR92007-06-29
FMI62001-01-08
NHJ52020-02-14
MBI52012-10-02
BYI42017-03-17
FPA32018-03-05
JSM32001-07-31
GEI22016-10-07
HQC22015-03-13
FGE22006-03-23
HTY22002-02-06
HRN12017-01-23
DYB12016-11-17
OXJ12016-11-17
DXC12016-10-21
OMP12016-10-19
HKY12016-04-19
DZE12015-11-06
FYA12015-05-21
DTZ12013-10-08
FRO12013-04-05
FMF12010-08-20
EZD12010-07-02
KFM12009-12-18
LHI12009-05-15
DRY12009-04-22
NEW12008-04-23
JOH12004-02-13
GAM12001-05-11
JTW11999-11-09
DTL11994-03-23
NAB11986-12-29
HEM11986-08-19