meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
34
Latest Decision
1983-02-08

Clearances · page 44 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K830224 UNSCENTED PANTY SHIELDS Weyerhaeuser Co. HHD Class I 1983-02-08
K823188 M2000 INTRAPARTUM FETAL MONITOR Huntleigh Technology, Inc. HGM Class II 1983-01-26
K823081 M2100 ANTEPARTUM FETAL MONITOR Huntleigh Technology, Inc. HGM Class II 1983-01-26
K823840 MEDELA NAMUAL BREAST PUMP Medela, Inc. HGY Class I 1983-01-24
K830012 MEDELA SUCTION PUMP Medela, Inc. HDB Class II 1983-01-24
K830144 PANTY-LINERS SCENTED Procter & Gamble Mfg. Co. HHL Class II 1983-01-21
K830145 PANTY-LINERS UNSCENTED Procter & Gamble Mfg. Co. HHD Class I 1983-01-21
K823461 AXIPUMP MANUAL BREAST PUMP D.J. Colgate Medical, Ltd. HGY Class I 1983-01-18
K830019 AMNIO CENTESES KIT W/NEEDLE Universal Medical Instrument Corp. HIO Class I 1983-01-18
K823517 THE KLINE APPLICATOR Kline Technologies, Ltd. HGD Class I 1983-01-18
K823792 QUARTZ RETRACTOR/PROBE American V. Mueller KOH Class I 1983-01-18
K823477 UNSCENTED MENSTRUAL PADS Procter & Gamble Mfg. Co. HHD Class I 1983-01-18
K823478 SCENTED MENSTRUAL PADS Procter & Gamble Mfg. Co. HHL Class II 1983-01-18
K823242 PROGRAMALITH PROGRAMMER Pacesetter Systems KNG Class II 1983-01-08
K823591 AMEDA HAND BREAST PUMP Burditt & Calkins-Siemens-Elema HGY Class I 1982-12-28
K823241 NEW FREEDOM THIN UNSCENTED MAXI PADS Kimberly-Clark Corp. HHD Class I 1982-12-28
K823239 SURE & NATURAL MAXISHIELDS Personal Products Co. HHD Class I 1982-12-16
K822812 YSI MODEL 23L LACTATE ANALYZER Yellow Springs Instrument Co., Inc. HHP Class II 1982-12-13
K823041 JEOL MODEL #JTG-500M Jeol IYM Class III 1982-11-24
K823080 VAKUTAGE Weston, Copco, Inc. HHK Class II 1982-11-24
K823245 THERMAX; THERMAX SYSTEM American Thermometer Company, Inc. KYA Class I 1982-11-16
K822086 DIA-SPEC Exitec, Inc. HIB Class II 1982-11-08
K823006 MEDEVICES ASPIRATION HOSE Berkeley Medevices HHK Class II 1982-11-04
K822088 MALE CONDOM Schmid Laboratories, Inc. HIS Class II 1982-11-03
K822792 NUDA-PLUS CONDOM W/SPERMICIDAL LUBRICANT Ansell, Inc. HIS Class II 1982-09-30
K822505 OBSTETRICAL KIT Parr Emergency Product Sales, Inc. HHD Class I 1982-09-30
K822830 MEDICAL LABS FETAL SCAN #1000 W/CENTRAL Cranbury Medical Labs, Inc. HGM Class II 1982-09-30
K822756 U.V.A.C. CURETTES American Hospital Supply Corp. HHD Class I 1982-09-28
K822403 LACT-ASSIST BREAST PUMP Lact-Assist, Inc. HGY Class I 1982-09-21
K822242 SANITARY/OB NAPKINS Hospital Specialty Co. HHD Class I 1982-09-09
K821524 CHIROPRATIC INFRA-RED CRYSTAL PAK Dr. John D. Reid B.A., D.C. KYA Class I 1982-09-08
K822433 GARDS (UNSCENTED, MENSTRUAL PAD) Hospital Specialty Co. HHD Class I 1982-08-30
K822382 U.V.A.C. HANDLER SET American Hospital Supply Corp. HHK Class II 1982-08-25
K822084 PRO-SPEC Exitec, Inc. HIB Class II 1982-08-19
K820672 HASSON BUEC-3 Bivona Medical Technologies HDP Class II 1982-07-30
K821478 TELEPHONE LINK DATA TRANSMISSION SYS Advantage Medical Systems, Inc. HGM Class II 1982-07-26
K821664 PP-100, PERSONAL PERINEOMETER Farrall Instruments, Inc. HIR Class II 1982-07-13
K821479 CENTRAL DISPLAY SYSTEM #CS400 Advantage Medical Systems, Inc. HGM Class II 1982-06-25
K821800 REGULAR MAXITHINS PADS & SUPER MAXITHINS Tampax, Inc. HHD Class I 1982-06-25
K821580 FETAL MONITOR #FM 750 Advantage Medical Systems, Inc. HGM Class II 1982-06-25
K821134 DC PACK TM Seamless Hospital Products Co. HFC Class II 1982-06-22
K820641 ACCURETTE Axcan Scientific Corp. HFF Class II 1982-06-22
K821616 CERVISCOPE OPTICAL SYSTEM Fotomedics, Inc. HEX Class II 1982-06-16
K821375 DEODORANT SURE & NATURAL MAXISHIELDS Personal Products Co. HHL Class II 1982-06-01
K820564 WORLD'S BEST (CONTRACEPTIVE) Rosen Kilde Stenhoj HIS Class II 1982-05-28
K821297 GRAVES SPECULA Conphar, Inc. HDF Class I 1982-05-24
K821291 PEDERSON VAGINAL SPECULA Conphar, Inc. HDF Class I 1982-05-24
K820960 MAXI & MINI SHIELDS Dafoe & Dafoe, Inc. HHD Class I 1982-05-14
K821049 PARATHERM American Thermometer Company, Inc. KYA Class I 1982-04-29
K820519 BIOPSER Advanced Biomedical Instruments HFB Class I 1982-04-29
K820174 TAMPAX TAMPONS Tampax, Inc. HEB Class II 1982-03-18
K813547 THERMASCAN Bcd Products, Inc. KXZ Class III 1982-03-12
K820522 CAREFREE PANTY SHIELDS Personal Products Co. HHD Class I 1982-03-08
K820261 MONITOR CO2 LASER SYSTEM Cooper Medical Corp. HHR Class II 1982-03-05
K820288 MINI SHIELDS MENSTRUAL PADS I.C.D. Industries, Inc. HHD Class I 1982-03-05
K813172 CONDOM-MULTIPAL STYLES Circle Rubber Corp. HIS Class II 1982-03-05
K820287 MAXI SHIELDS MENSTRUAL PADS I.C.D. Industries, Inc. HHD Class I 1982-03-05
K813457 FETASCAN 2000,2000A OBSTETRICAL DATA Cranbury Medical Labs, Inc. HGM Class II 1982-02-12
K820115 EMMETT IUD THREAD RETREIVER Proto-Med, Inc. HHF Class I 1982-02-05
K820175 O.N.A.T. Latex Medical Devices, Inc. KNC Class II 1982-01-29
K827885 BIO-DERM COUPLING LOTION Whs Products, Inc. HGL Class II 1982-01-29
K813458 FETASCAN 1000, 1000A OBSTETRICAL DATA Cranbury Medical Labs, Inc. HGM Class II 1982-01-28
K813642 PETAL SOFT PLASTIC APPLICATOR TAMPAX Tampax, Inc. HEB Class II 1982-01-25
K813251 UNSCENTED MENSTRUAL PADS-MAXI PADS I.C.D. Industries, Inc. HHD Class I 1981-12-14
K813252 UNSCENTED MENSTRUAL PADS-MINI PADS I.C.D. Industries, Inc. HHD Class I 1981-12-14
K813282 SYNEVAC VACUUM CURETTAGE SYSTEMS Synemed, Inc. HHI Class II 1981-12-14
K813007 EPCOM EMS-180 ANTEPARTUM FETAL MONITOR Epcom Medical Systems, Inc. HGM Class II 1981-12-10
K813298 CONPHAR DELEE HILLIS STETHOSCOPE Conphar, Inc. HGN Class I 1981-12-08
K813247 KANESON/COMFORT PLUS MANUAL BREAST PUMP Marshall Electronics, Inc. HGY Class I 1981-12-03
K812868 FETAL PULSE DETECTORS, F50/F60 South Carolina Medical, Inc. KNG Class II 1981-11-25
K813133 KEYMED KEY LIGHT Keymed, Inc. HET Class II 1981-11-20
K812863 FETASONDE 5, #30, CENTRAL NURSING STAT Kontron Instruments, Inc. HGM Class II 1981-11-06
K812870 IMPROVED PLAYTEX TAMPON Playtex, Inc. HEB Class II 1981-10-29
K812799 DCATS Dorex, Inc. IYM Class III 1981-10-20
K812256 MODEL AP 180 MINI-MONITOR Sonicaid, Inc. HGM Class II 1981-10-20
K812577 UNSCENTED MENSTRUAL PADS Weyerhaeuser Co. HHD Class I 1981-10-19
K812206 LAPAROSCOPE Reznik Instruments HET Class II 1981-10-13
K812199 TROCAR & TROCAR SLEEVES Reznik Instruments HET Class II 1981-10-13
K812701 ORTHO-THERM INFRARED SENSOR Orthion Corp. IYM Class III 1981-10-13
K812204 UTERINE MANIPULATORS Reznik Instruments KOH Class I 1981-10-13
K812426 UTERINE ASPIRATION CURETTES(RIGID&FLEX) Medi-Spec HHK Class II 1981-10-08
K812618 ASSURE NATURAL FIT TAMPON Personal Products Co. HIL Class II 1981-10-02
K812200 INSUFFLATOR Reznik Instruments HIF Class II 1981-09-29
K812202 FIBER OPTIC LIGHT SOURCE Reznik Instruments HIH Class II 1981-09-29
K811761 THE EMMETT IUD THREAD RETRIEVER Proto-Med, Inc. HHF Class I 1981-09-21
K812175 ENDOCERVICAL ASPIRATOR Fertility Instrumentation, Inc. HFC Class II 1981-09-21
K812534 IMPROVED PLAYTEX TAMPON Playtex, Inc. HIL Class II 1981-09-21
K812403 SCENTED MENSTRUAL PADS Procter & Gamble Mfg. Co. HHL Class II 1981-09-09
K812402 UNSCENTED MENSTRUAL PADS Procter & Gamble Mfg. Co. HHD Class I 1981-09-09
K812333 CYCLES REUSABLE MENSTRUAL PADS Cycles HHD Class I 1981-09-08
K811270 SCOPE MASTER Synemed, Inc. HIH Class II 1981-09-08
K811902 CENTURY BIRTHING CHAIR Century Manufacturing Co. KNC Class II 1981-08-25
K812232 OBSTETRICAL PAD(STEAM STERILIZED) Paper-Pak Products, Inc. HHD Class I 1981-08-25
K812141 LIC OBSTETRICAL TABLE Lada Intl., Inc. KNC Class II 1981-08-25
K811385 PLAYTEX DIGITAL TAMPON Playtex, Inc. HEB Class II 1981-08-07
K811388 PLAYTEX COTTON DIGITAL TAMPON Playtex, Inc. HEB Class II 1981-08-07
K811389 PLAYTEX COTTON TAMPONS Playtex, Inc. HIL Class II 1981-08-07
K811387 PLAYTEX COMBINATION FIBER MODIFIED TAMP Playtex, Inc. HIL Class II 1981-08-07
K811992 ASSURE NATURAL FIT TAMPON Personal Products Co. HEB Class II 1981-07-20
K811983 JOHNSON & JOHNSON O.B. TAMPONS Johnson & Johnson Professionals, Inc. HEB Class II 1981-07-20

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