FDA.reportPublic FDA data

MEDGYN PRODUCTS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
14509081450908MEDGYN PRODUCTS, INC.1Y2026-01-01800 Pasquinelli Dr Westmont IL US 60559

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
M803010466MedGyn Video Colposcope - Video Colposcope16309257446amar@medgyn.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
26801787167191K990387ENDOMETRIAL SAMPLERHHK1999-04-20
26801241232307K974357UTERINE MANIPULATOR/INJECTORLKF1998-02-02
26802016946057K973853KOLPLAST VAGINAL SPECULUMHIB1997-12-19
26801275863965K945179BOTTLE COLLECTION SETHGF1995-01-26
26801730887817K922878MODEL GT1ST CRYOSURGICAL INSTRUMENTGEH1992-09-02
26801762344279K912422SURG/ASSIST MODEL SA-1FYD1991-08-12
26801033629698K911327CELL SWEEPHHT1991-05-21
26801770937382K892220LAMINARIA TENTHDY1989-06-14
26801160781139K880196LAMINARIAHDY1988-05-06
26801353975705K880195GYNESCOPEHEX1988-03-14
26801402562880K840952MEDEVICE V-80 VACUUM PUMPHHI1984-03-30
26801891445178K840383MENSTRUAL ASPIRATION KITHHI1984-04-30
26801668895635K840382VACUUM ASPIRATION CATHETERHHI1984-04-30
26801431317279K831085SYNEVAC VACUUM SOURCE UNITBTA1983-06-08
26801242351060K823006MEDEVICES ASPIRATION HOSEHHK1982-11-04
26801815571767K813282SYNEVAC VACUUM CURETTAGE SYSTEMSHHI1981-12-14
26801389104283K143669MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI CatheterMQF2015-11-23
26801135419228K140213DISPOSABLE ENDOSCOPIC CANNULAHGH2015-03-25
26801535438573K132313PESSARYHHW2014-12-05
26801928123599K131305CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBEIYN2013-08-01
26801846749139K123258THE ADVANCE CATHETER FOR HSG AND SISLKF2013-01-31
26801416298642K122973AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPEHEX2013-06-12
26801790852938K120154INTRAUTERINE INSEMINATION (IUI) CATHETERMQF2012-03-21
26801204193544K110766KOLPLUX SYSTEMHIB2011-09-15
26801277987646K092997ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6KNG2009-11-10
26801798531183K092983PANPAC HSG CATHETER SETLKF2010-06-07
26801063738416K092980PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5LKF2010-03-11
26801944830063K082602FETAL & MATERNAL MONITOR, MODEL F6, F9HGM2008-11-26
26801329208301K082369CADENCE, CADENCE DUAL, CADENCE II FETAL MONITORHGM2008-11-07
26802030240038K072210CHISON, MODEL 8300IYO2007-08-24
26801745333346K052059IUI CATHETER, MODEL 9057MQF2005-11-22
26802041335124K051742OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SHMQE2005-10-07
26801526465410K050521EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-SMQF2005-05-02
26801959025906K041470MORTON IUI CATHETERSMQF2004-11-22
26801293895348K040903CADENCE, MODELS 2001 AND 2002HGM2004-09-02
26801778276739K040480SONOTRAX ULTRASONIC POCKET DOPPLERKNG2004-05-25
26801539750656K032835H/S CATHETER SETLKF2003-12-11
26801215235349K023017TUCKER EMBRYO CATHETERMQF2002-12-13
26801491611137K022593THOMAS MEDICAL ELECTRODESHGI2002-11-01
26801312628922K022503UTERINE INJECTORLKF2002-10-25
26802069197588K020292UTERINE INJECTORLKF2002-04-17
26801587478556K013289BIOTEQUE VAGINAL PESSARIESHHW2001-12-27
26801255195179K011601ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XXBTA2001-06-08
26801833063021K003380BIOTEQUE VAGINAL DILATORHDX2001-01-29
26801546614652
26801002049417
26801013617351
26801037377234
26801095655790
26801103998476
26801188581364
26801235795758
26801321158823
26801433241563
26801474063691
26801480194851
26801513259822
26801647162026
26801665166347
26801805483073
26801832650102
26801846363570
26801924436187
26801950171416
26801998119205

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LKF72013-01-31
MQF62015-11-23
HHI41984-04-30
HGM32008-11-26
HHW22014-12-05
HEX22013-06-12
HIB22011-09-15
KNG22009-11-10
BTA22001-06-08
HHK21999-04-20
HDY21989-06-14
HGH12015-03-25
IYN12013-08-01
IYO12007-08-24
MQE12005-10-07
HGI12002-11-01
HDX12001-01-29
HGF11995-01-26
GEH11992-09-02
FYD11991-08-12
HHT11991-05-21

PMN#

GUDID#

200 records. Showing 1-40. Next