meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
37
Latest Decision
1984-08-23

Clearances · page 43 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K842950 SUPER MAXITHINS BODY-SHAPED MAXI PADS Tambrands, Inc. HHD Class I 1984-08-23
K833365 ULTRA SHAPE CONDOMS Barnetts, Inc. HIS Class II 1984-08-22
K842952 REGULAR MAXITHINS BODY-SHAPED MAXI Tambrands, Inc. HHD Class I 1984-08-22
K841311 ASSURE-BREATHABLE PANTY LINERS/UNSCENT Personal Products Co. HHD Class I 1984-08-20
K841312 ASSURE-BREATHABLE PANTY LINERS/SCENT Personal Products Co. HHL Class II 1984-08-20
K842014 HOSPITAL'S-SPEC Merex Co. HIB Class II 1984-08-17
K842763 UNSCENTED MENSTRUAL PAD Procter & Gamble Mfg. Co. HHD Class I 1984-08-10
K842764 SCENTED MENSTRUAL PAD Procter & Gamble Mfg. Co. HHL Class II 1984-08-10
K842185 PROTEX CONTRACEPT PLUS W/SPERM-LUB National Sanitary Laboratories, Inc. HIS Class II 1984-07-31
K841909 VAGINAL SPECULUM - DISPOSABLE Galenica Enterprises, Inc. HIB Class II 1984-07-31
K841271 INFRA-EYE 160 Fujitsu , Ltd. LHQ Class I 1984-07-28
K842618 SUPER PETAL SOFT PLASTIC APPLICATOR TAMP Tambrands, Inc. HEB Class II 1984-07-26
K842619 REGULAR PETAL SOFT PLASTIC APPLICATOR Tambrands, Inc. HEB Class II 1984-07-26
K840874 RODY BREAST PUMP Kean-Rody Manufacturer HGY Class I 1984-07-23
K841867 KIDD VAGINAL SPECULUM Paul H. Schneider Ent. HIB Class II 1984-07-13
K841682 UTERINE INJECTOR 4.0MM Humi Corp. HES Class II 1984-07-03
K841631 MODEL 3014 SUCTION UNIT Forma Scientific, Inc. HHI Class II 1984-07-03
K842480 SURE & NATURAL MAXI-SHIELD Johnson & Johnson Professionals, Inc. HHD Class I 1984-07-03
K842112 TISCHLER CERVICAL BIOPSY PUNCH FORCEPS J. Sklar Mfg. Co., Inc. HFB Class I 1984-07-03
K841805 OBSTETRICAL DOPPLER Epcom Medical Systems, Inc. KNG Class II 1984-06-19
K841710 MAC LEE VAGINAL IRRIGATOR Mac Lee Medical Products HED Class I 1984-06-19
K840747 TOCO DATA TELEPHONE TRANSMITTER DT100P Advantage Medical Systems, Inc. HFM Class II 1984-06-19
K831212 ENDOSCANN Axcan Scientific Corp. HFF Class II 1984-06-15
K841825 SCOPE LIGHT Zinnanti Surgical Instruments, Inc. HIH Class II 1984-06-15
K841477 COROMETRICS 815 FETAL ECG RECORDER Ge Medical Systems Information Technologies HGM Class II 1984-05-14
K840623 OBSTETRICAL ULTRASOUND COMPUTER R & S Systems HEM Class II 1984-05-11
K841004 SURGICAL CURETTE, VARIOUS Premier Dental Products Co. HCY Class I 1984-05-11
K840285 NON STRESS TEST MONITOR 507 Imex Medical Systems, Inc. HGH Class II 1984-05-09
K841492 AB VACUUM EXTRACTOR SILC-CUP Medela, Inc. HDB Class II 1984-05-07
K840382 VACUUM ASPIRATION CATHETER Intl. Medical Technologies, Inc. HHI Class II 1984-04-30
K840384 DIAGNOSTIC DILATATION & MENSTRUAL KIT Intl. Medical Technologies, Inc. HHI Class II 1984-04-30
K840381 TAPERED CERVICAL DILATOR Intl. Medical Technologies, Inc. HHI Class II 1984-04-30
K840380 UTERINE SOUND Intl. Medical Technologies, Inc. HHM Class I 1984-04-30
K840383 MENSTRUAL ASPIRATION KIT Intl. Medical Technologies, Inc. HHI Class II 1984-04-30
K840008 O'NEIL OBSTETRIC CUP Go Medical Industries Pty. , Ltd. HDB Class II 1984-04-25
K840352 CIN-SHEAR Roland J. Zwick, Inc. HFB Class I 1984-04-05
K834564 MENSTRUAL PADS Probel-U.S., Inc. HHL Class II 1984-03-30
K840952 MEDEVICE V-80 VACUUM PUMP Berkeley Medevices HHI Class II 1984-03-30
K841155 DEODORANT SLENDER REG. TAMPONS Playtex, Inc. HIL Class II 1984-03-19
K841154 PLAYTEX SLENDER REGULAR TAMPONS Playtex, Inc. HIL Class II 1984-03-19
K840325 INFA COMPLETE BREAST PUMP & MILK STORAG Monterey Laboratories, Inc. HGY Class I 1984-03-05
K840308 CAT. 4-OBSTETRICS GYNECOLOGY DEV'S Imm Enterprises , Ltd. KOH Class I 1984-03-05
K832986 PAP SMEAR BRUSH Donald G. Zeller HHT Class II 1984-02-10
K834591 STOPEX-CONDOMS- Tropex Worldwide, Inc. HIS Class II 1984-02-04
K833068 LAMINARIA JAPONICA CERVICAL DILATOR Medi-Spec HDY Class II 1984-02-04
K832731 BREAST & BODY HEALTH SYSTEM 2000 American Thermal Instruments, Inc. KXZ Class III 1984-01-30
K832989 BREAST THERMAL ACTIVITY INDICATOR Bcsi Laboratories, Inc. KYA Class I 1984-01-17
K834399 NEW MOTHER'S WAY-BREAST PUMP Huntleigh Technology, Inc. HGY Class I 1984-01-17
K834302 STAYFREE* DEODORANT MAXI-PADS Johnson & Johnson Professionals, Inc. HHL Class II 1984-01-17
K832818 UNSCENTED MENSTRUAL TAMPON Bnt Co, Inc. HEB Class II 1984-01-17
K833179 O.B. TAMPONS Personal Products Co. HEB Class II 1984-01-03
K834144 UNSCENTED MENSTRUAL PAD Procter & Gamble Mfg. Co. HHD Class I 1983-12-29
K834131 SCENTED MENSTRUAL PAD Procter & Gamble Mfg. Co. HHL Class II 1983-12-29
K834173 OP-CON SURGICAL INSTRUMENTS #4 Imm Enterprises , Ltd. LBX Class II 1983-12-27
K834177 H.R. JAKOBI SURG. INSTRUMENTS #4 30/31 Imm Enterprises , Ltd. HGE Class I 1983-12-27
K834174 OP-CON SURGICAL INSTRUMENTS #4 Imm Enterprises , Ltd. HCZ Class II 1983-12-27
K833765 TROJAN PLUS II Youngs Rubber Corp. HIS Class II 1983-12-16
K834088 GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLING Whs Products, Inc. HEM Class II 1983-12-15
K832973 TAMPAX SUPER DEODORANT MAXITHINS Tampax, Inc. HHL Class II 1983-11-28
K832971 DEODORANT MAXITHINS PANTY SHIELD Tampax, Inc. HHL Class II 1983-11-28
K833835 GENTLE FLOW BREAST PUMP Eklund & Co. HGY Class I 1983-11-28
K833488 SONICOMP Sonicaid, Inc. HEM Class II 1983-11-28
K832972 REGULAR DEODORANT MAXITHINS PADS Tampax, Inc. HHL Class II 1983-11-28
K833321 LABOR/DELIVERY/RECOVERY BED LDR-600 Adel Medical , Ltd. KNC Class II 1983-11-14
K831224 AUGROS HYSTEROMETER Axcan Scientific Corp. HHM Class I 1983-10-28
K832974 MAXITHINS UNSCENTED PANTY SHIELDS Tampax, Inc. HHD Class I 1983-10-14
K832849 FETAL MONITOR #FM-2 Advantage Medical Systems, Inc. HGM Class II 1983-10-04
K831929 BASIC BREAST PUMP Terayco Intl., Ltd. HGY Class I 1983-09-29
K832597 GERBER PRECISION CARE BREAST PUMP Gerber Products Co. HGY Class I 1983-09-12
K831816 PROTEX CONTRACEPT PLUS W/SPERM-LUB National Sanitary Laboratories, Inc. HIS Class II 1983-09-12
K831667 FEMININE HYGIENE DEVICE Snow Willow Co. HED Class I 1983-09-12
K831998 BIRTHWELL BIRTHING SYSTEM Qulab Co. KNC Class II 1983-09-12
K831113 EPCOM EMS-310 INTRAPARTUM MONITOR Epcom Medical Systems, Inc. HGM Class II 1983-08-12
K831114 EPCOM EMS-330 FREEDOM I TELEDOP OBSTET Epcom Medical Systems, Inc. HGM Class II 1983-08-12
K831115 EPCOM EMS-320 REMOTE MONITORSCOPE Epcom Medical Systems, Inc. HGM Class II 1983-08-12
K831593 MAXI SHIELDS Weyerhaeuser Co. HHD Class I 1983-08-12
K832382 CAREFREE * PANTY SHIELDS-REG/DEOR Johnson & Johnson Professionals, Inc. HHL Class II 1983-08-12
K831852 FETAL MONITOR #115 Ge Medical Systems Information Technologies HGM Class II 1983-08-11
K831669 AXCAN SPERM CUP Axcan Scientific Corp. HDR Class II 1983-07-12
K831568 RELIANCE TEMPO OPHTH. INSTR STAND F. & F. Koenigkramer HHF Class I 1983-06-30
K831459 FETAL BLOOD SAMPLING KIT #1560 Transidyne General Corp. HGW Class II 1983-06-30
K831112 EPCOM VCU-1 VACUUM SYSTEM & CURETTE Epcom Medical Systems, Inc. HHI Class II 1983-06-30
K831371 MODEL FM5 Sonicaid, Inc. HGM Class II 1983-06-30
K831691 PRIVATE LABEL DEODORANT MAXISHIELD Int'L Consumer Disposables HHL Class II 1983-06-30
K831707 MODIFIED UNSCENTED MENSTRUAL PADS Personal Products Co. HHD Class I 1983-06-16
K831693 MAXI PADS SCENTED DEODORIZED Int'L Consumer Disposables HHL Class II 1983-06-16
K831309 DELIVERY 4 TABLE Amsco Co. KNC Class II 1983-06-15
K831241 LASER LAPARAXOPE Eder Instrument Co, Inc. HET Class II 1983-06-10
K830873 S & W MODEL ASO S & W Enterprises, Inc. KNC Class II 1983-05-13
K823294 MEDIGROUP LS-110 LIGHT SOURCE Medigroup HET Class II 1983-05-09
K831229 SUPER SNAPS Shofu Dental Corp. FHJ Class II 1983-05-09
K823295 MEDIGROUP 2.2MM NEEDLESCOPE CANNULA& Medigroup HET Class II 1983-05-06
K823297 ST-610 NEEDLESCOPE STERILIZATION TRAY Medigroup HET Class II 1983-05-06
K823293 MEDIGROUP LG-102 LIGHT GUIDE Medigroup HET Class II 1983-05-05
K830725 GENT-L-SPEC DISPOS. VAGINAL SPECULUM Geneva Laboratories, Inc. HIB Class II 1983-04-27
K830630 PRIVATE LABE/ DEODORANT MAXIPAD Int'L Consumer Disposables HHL Class II 1983-04-18
K830966 PLAYTEX TAMPONS Playtex, Inc. HIL Class II 1983-04-08
K830691 PRIME Ansell, Inc. HIS Class II 1983-03-31
K822584 MULTI-PRONG FETAL SCALP ELECTRODE Kontron Instruments, Inc. HGP Class II 1983-02-24
K823937 SEMINAL COLLECTION DEVICE Health Development Corp. HIS Class II 1983-02-24

4,626 clearances in the Obstetrics/Gynecology panel. Data: openFDA.