meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
33
Latest Decision
1985-09-06

Clearances · page 42 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K853000 SCENTED ALWAYS PANTILINERS Procter & Gamble Mfg. Co. HHL Class II 1985-09-06
K852171 CAT. NO. S-5300-E BIRTHING BED Shampaine/Wilson KNC Class II 1985-08-30
K852439 FETA SCAN 1000 OBSTETRICAL IMAGER International Biomedics, Inc. HEM Class II 1985-08-30
K853192 KOTEX SECURITY TUBE TAMPON Kimberly-Clark Corp. HEB Class II 1985-08-29
K852985 UNSCENTED ALWAYS PANTILINERS Procter & Gamble Mfg. Co. HHD Class I 1985-08-29
K852924 LAURIER SAFETY LONG SANITORY NAPKIN Kao Corp. HHD Class I 1985-08-27
K852922 LAURIER OVERNIGHT SANITARY NAPKIN Kao Corp. HHD Class I 1985-08-26
K851941 UNSCENTED MENSTRUAL TAMPONS Personal Products Co. HEB Class II 1985-08-23
K844173 FEMTEST Bionexus, Inc. HES Class II 1985-08-14
K852225 BELIEVE DEODORANT LABIAL PADS Kimberly-Clark Corp. HHL Class II 1985-08-13
K852031 ENDOPORT 5MM Endotherapeutics HET Class II 1985-08-13
K852226 BELIEVE LABIAL PADS Kimberly-Clark Corp. HHD Class I 1985-08-09
K850705 THE WHITE RIVER PORTA-ELEC-BREAST PUMP Natural Technologies, Inc. HGX Class II 1985-07-11
K852518 MODIFICATION FETAL MONITOR MODEL FM-2 Advantage Medical Systems, Inc. HGM Class II 1985-07-05
K852076 MODEL 145 FETAL MONITOR Ge Medical Systems Information Technologies HGM Class II 1985-07-05
K851934 CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULA Tridak Division of Indicon, Inc. HHT Class II 1985-07-05
K852357 GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP Gyneco, Inc. HFB Class I 1985-07-05
K850753 NATURAL MOTHER BREAST PUMP Crystal Medical Products, Inc. HGX Class II 1985-06-07
K851292 LOVESAFE DOTTY CONDOM ONE DZ. CODOMS/BOX, DC-20 Manexim Multicorp, Ltd. HIS Class II 1985-05-23
K850632 PMS AMNIOCENTESIS TRAY/KIT Professional Medical Services HIO Class I 1985-05-22
K851291 LOVESAFE PLAIN CONDOM 1/4 DZ. CONDOMS/BOX PC-30 Manexim Multicorp, Ltd. HIS Class II 1985-05-22
K852063 PLAYTEX SLENDER REG. TAMPONS & DEODORANT TAMPONS Intl. Playtex, Inc. HEB Class II 1985-05-22
K851290 LOBESAFE PLAIN CONDOM DOZEN CONDOMS/BOX,PC-10 Manexim Multicorp, Ltd. HIS Class II 1985-05-22
K851252 COROMETRICS 115 FETAL MONITOR W/DUAL CARDIOTACHOME Ge Medical Systems Information Technologies HGM Class II 1985-05-22
K851799 61-100 TO 61-124 VARIOUS VAGINAL SPECVIA(CUSCO,GRA Artiberia HDF Class I 1985-05-22
K845021 MEDICAL DYNAMICS MCCONNELL PRECISION ELEC-INSUFFLA Medline Industries, Inc. HIF Class II 1985-05-20
K850956 ALWAYS MAXIPADS - SCENTED Procter & Gamble Mfg. Co. HHL Class II 1985-05-14
K850940 ALWAYS SUPER MAXIPAD-UNSCENTED Procter & Gamble Mfg. Co. HHD Class I 1985-05-14
K850955 ALWAYS MAXIPADS - UNSCENTED Procter & Gamble Mfg. Co. HHD Class I 1985-05-14
K850939 ALWAYS SUPER MAXIPAD-SCENTED Procter & Gamble Mfg. Co. HHL Class II 1985-05-14
K851883 SIMPSON OBSTETRICAL FORCEPS-SS TYPE 410 OR 420 The Huxley Instrument Corp. HDA Class II 1985-05-09
K844724 FETAL TELEMETRY SYSTEM Advantage Medical Systems, Inc. HGM Class II 1985-05-01
K844829 ABDOMINAL PRESSURE CONTROL VALVE L.A.S.E.R., Inc. HHR Class II 1985-05-01
K845006 SUN MEDICAL LAMINARIA CERVICAL DILATOR Sun Medical, Inc. HDY Class II 1985-05-01
K844608 SURGICRAFT COPELAND DISPOSABLE A.W. Showell (Surgicraft) , Ltd. HGP Class II 1985-05-01
K850758 AMNIGLOVE & AMNICOT Go Medical Industries Pty. , Ltd. HGE Class I 1985-04-15
K851355 PLAYTEX SUPER PLUS TAMPONS & DEODORANT TAMPONS Intl. Playtex, Inc. HEB Class II 1985-04-12
K851356 PLAYTEX SUPER TAMPONS & SUPER DEODORANT TAMPONS Intl. Playtex, Inc. HEB Class II 1985-04-12
K851110 GAYLOR-THOMS UTERINE BIOPSY FORCEPS 1810-144 PCS. The Huxley Instrument Corp. HFB Class I 1985-04-08
K850068 LUNE AU CURETTES Luneau Laboratories HCY Class I 1985-04-08
K850676 SURGI-PAP KIT Surgipath Medical Industries, Inc. HHT Class II 1985-03-22
K842878 GST SYSTEM THERMOGRAPHIC APPLICATION Gst Laboratories of Ca, Inc. LHQ Class I 1985-03-22
K850034 KOTEX THIN MAXI PADS Kimberly-Clark Corp. HHD Class I 1985-03-01
K850033 KOTEX MAXI PADS Kimberly-Clark Corp. HHD Class I 1985-03-01
K850312 GYNASPYR VACUUM CURETTAGE UNIT Roseburg SA HHI Class II 1985-02-28
K850534 BSI MODEL MCT 7000-THERMAL IMAGING SYSTEM Bales Scientific, Inc. LHQ Class I 1985-02-27
K844771 INFRAVIEW/INFRASION-TELETHERMOGRAPHIC SYSTEM Image Systems, Inc. LHQ Class I 1985-02-27
K844431 YN CO2 LASER SYSTEM 30W Cryomedics, Inc. HHR Class II 1985-02-25
K844297 SUPPLEMENTAL FEEDING SYSTEM Medela, Inc. HGY Class I 1985-02-25
K850242 CRYSTAL MANUAL BREAST PUMP Crystal Medical Products, Inc. HGY Class I 1985-02-25
K844975 SCENTED BREATHABLE MINI-SHIELD PRIVATE LABEL BRAND I.C.D. Industries, Inc. HHL Class II 1985-02-25
K843941 ENDOCYTE Gyneco, Inc. HFE Class II 1985-02-25
K833528 CARBON DIOXIDE LASER ML 825 Merrimack Laboratories HHR Class II 1985-02-19
K844013 CARE ELECTRIC BREAST PUMP Hankscraft Div. of Gerber Products Co. HGX Class II 1985-02-15
K850437 DISPOSABLE LARYNGOSCOPE Vital Signs, Inc. LLW Class II 1985-02-14
K843549 PROBEYE THERMAL VIDEO SYSTEMS Hughes Aircraft Co. LHQ Class I 1985-02-11
K844935 ORIGINAL REGULAR TAMPAX TAMPONS Tambrands, Inc. HEB Class II 1985-02-07
K844936 SUPER TAMPAX TAMPONS Tambrands, Inc. HEB Class II 1985-02-07
K844307 EGNELL-LACT B BATTERY-OPERATED BREAST PUMP Egnell, Inc. HGX Class II 1985-02-04
K843515 MINUTEMAN CO2 MICROSURGICAL LASER GYN American Surgical Laser, Inc. HHR Class II 1985-02-04
K844183 PALMER OBSTETIC BRACE Mic Medical Corp. KNC Class II 1985-02-04
K844558 UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE Universal Medical Instrument Corp. HIO Class I 1985-01-31
K843544 THE BIBICURE SYS BREAST TONER Les Entreprises Bibi, Inc. HGY Class I 1985-01-25
K844821 MICROINFERTILITY NEEDLE HOLDER, TITANIUM Precision Surgical Instrument, Inc. KNA Class II 1985-01-16
K844602 SCENTED MENSTRUAL PAD Procter & Gamble Mfg. Co. HHD Class I 1985-01-16
K844601 UNSCENTED MENSTRUAL PAD Procter & Gamble Mfg. Co. HHD Class I 1985-01-16
K844822 MICROINFERTILITY SCISSORS, TITANIUM Precision Surgical Instrument, Inc. KNA Class II 1985-01-16
K844823 MICROINFERTILITY FORCEPS, TITANIUM Precision Surgical Instrument, Inc. KNA Class II 1985-01-16
K844342 SURE & NATURAL MAXISHIELDS W/SUPERABSORBENT Personal Products Co. HHD Class I 1985-01-10
K844035 MENSTRUAL PADS American Disposable Products Corp. HHD Class I 1984-12-27
K844053 CANON 60 DEGREE FUNDUS CAMERA CF-60S Canon USA, Inc. HFI Class II 1984-12-19
K843918 COROMETRICS FETAL MONITOR 142 Ge Medical Systems Information Technologies HGM Class II 1984-12-17
K843551 PLAYTEX BABY POWDER DEODORANT TAMPONS Playtex, Inc. HIL Class II 1984-12-03
K843385 COROMETRICS 115 FETAL MONITOR Ge Medical Systems Information Technologies HGM Class II 1984-11-29
K843124 Q-SCAN THERMOGRAPHY SYSTEM Qmax Medical, Inc. KXZ Class III 1984-11-29
K841600 CASABLANCA Arcon Corp. HIS Class II 1984-11-29
K843958 DEODORANT SUPER MAXITHINS BODY-SHAPED MAXI PADS Tambrands, Inc. HHL Class II 1984-11-07
K843959 DEODORANT REGULAR MAXITHINS BODY-SHAPED MAXI PADS Tambrands, Inc. HHL Class II 1984-11-07
K843960 DEODORANT MAXITHINS BODY-SHAPED PANTY SHIELDS Tambrands, Inc. HHL Class II 1984-11-07
K843011 TERM GUARD 5000 UTERINE ACTIVITY Tokos Medical Corp. HFM Class II 1984-11-01
K843886 SCENTED BREATHABLE PRIVATE LABEL MINI-SH I.C.D. Industries, Inc. HHL Class II 1984-10-25
K842837 SAFE & SOFT MAXI SHILEDS Ipco Corp. HHD Class I 1984-10-15
K843401 RIA PANTY SHIELDS Paul Hartmann Corp. HHD Class I 1984-10-15
K842836 SAFE & SOFT MINI PADS & MAXI PADS Ipco Corp. HHD Class I 1984-10-15
K843318 LAURIER SANITARY NAPKIN Kao Corp. HHD Class I 1984-10-15
K842295 INTRAUTERINE DEVICE REMOVER Premier Dental Products Co. HHF Class I 1984-10-12
K843015 SANITARY PANTY W/PADS & DESIGNED Hygienics Industries, Inc. HHD Class I 1984-10-05
K843602 BREATHABLE MINI-SHIELD-PRIVATE LABEL I.C.D. Industries, Inc. HHD Class I 1984-10-05
K842838 SAFE & SOFT PANTY SHIELDS Ipco Corp. HHD Class I 1984-10-05
K843388 WELLINGTON HOSPITAL PATTERN SELF-RETAIN Downs Surgical , Ltd. HDF Class I 1984-10-01
K842962 LORRAINE DSL LABOR & DELIVERY BED Pulley-Kellam Co., Inc. KNC Class II 1984-09-25
K842498 DANIELL DBL PUNCTURE LASER LAPAROSCOPY Laser Spectrum, Inc. HET Class II 1984-09-25
K842766 CRYSTAL MEDICAL MILK COLLECTION KIT Crystal Medical Products, Inc. HGX Class II 1984-09-25
K842502 WRINKLE CHAPEAU BLACKY Circle Rubber Corp. HIS Class II 1984-09-21
K842943 AXCAN UTERINE SUCCION INJECTOR Axcan Scientific Corp. HIG Class II 1984-09-21
K842261 OB ULTRASOUND LINEAR SCANNER 630 Ge Medical Systems Information Technologies HEM Class II 1984-09-19
K842231 ACKRAD HYSTEROSALPINGOGRAPHY SET Ackrad Laboratories KNA Class II 1984-09-19
K843061 TAMBRANDS INC. ILL.P. 2 Tambrands, Inc. HHD Class I 1984-08-24
K843155 SURE & NATURAL DEODORANT MAXI-SHIELD Johnson & Johnson Professionals, Inc. HHL Class II 1984-08-24
K842951 MAXITHINS BODY-SHAPED PANTY SHIELDS Tambrands, Inc. HHD Class I 1984-08-23

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