meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
28
Latest Decision
1987-07-10

Clearances · page 40 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K872256 TAMPAX DEODORANT TAMPON, ORIGINAL REGULAR Tambrands, Inc. HIL Class II 1987-07-10
K872255 TAMPAX DEODORANT TAMPON, SUPER PLUS Tambrands, Inc. HIL Class II 1987-07-10
K872260 TAMPAX DEODORANT TAMPON, SLENDER REGULAR Tambrands, Inc. HIL Class II 1987-07-10
K871745 MODEL 26021C BIPOLAR COAGULATOR KARL STORZ Endoscopy-America, Inc. HIN Class II 1987-07-10
K872258 TAMPAX PETAL SOFT DEODORANT TAMPON, SUPER PLUS Tambrands, Inc. HIL Class II 1987-07-10
K871715 ADVERTISING AND LABEL CHANGE ON TAMBRANDS TAMPONS Tambrands, Inc. HEB Class II 1987-06-30
K871552 ORTHO* SPECIMEN COLLECTION CYTOBRUSH Ortho Diagnostic Systems, Inc. HHT Class II 1987-06-26
K871682 WALLACH CONVERTIBLE COLPOSCOPE Wallach Surgical Devices, Inc. HEX Class II 1987-06-24
K872018 KOTEX STICK TAMPONS, REGULAR AND SUPER Kimberly-Clark Corp. HEB Class II 1987-06-24
K870066 KAY-PLUS & VARIOUS VANIA SANITARY LINERS & PADS Cascades Psh, Inc. HHL Class II 1987-06-19
K871304 LIFESTYLES EXTRA STRENGTH CONDOMS W/NONOXYNOL-9 Ansell, Inc. HIS Class II 1987-06-11
K871716 ULTRA MAXITHINS PADS Tambrands, Inc. HHD Class I 1987-06-11
K871300 VIP'S PROPHYLACTICS, NATURAL, ANATOMIC & FEMINA Professional Pharmacy West, Inc. HIS Class II 1987-06-08
K863439 INTRAUTERINE HEMOSTASIS BALLOON STENT Mentor Corp. KNA Class II 1987-06-02
K871383 FETALERT ADR FETAL MONITOR Advanced Technology Laboratories, Inc. HGM Class II 1987-06-01
K871385 MODEL U-1000 WITH GESTATIONAL AGE CALCULATION Fukuda Denshi USA, Inc. HGM Class II 1987-05-26
K865106 PROPHYLACTIC (CONDOM) MR. JOHNNY Medelec Intl. Corp. HIS Class II 1987-05-20
K870782 CYCLO-BRUSH Medline Industries, Inc. HHT Class II 1987-05-18
K871642 TAMPAX TAMPON, REGULAR Tambrands, Inc. HEB Class II 1987-05-12
K871197 PLAYTEX TAMPONS AND DEODORANT TAMPONS Intl. Playtex, Inc. HIL Class II 1987-05-12
K870803 THE KEEPER The Keeper Co. HHE Class II 1987-05-06
K870692 PERINATAL COMPUTERS 2015/2025/2040/2045/2080/2085 Peritronics Research and Development, Inc. HGM Class II 1987-05-04
K871210 KOTEX PROFILE SHAPED MAXI PAD Kimberly-Clark Corp. HHD Class I 1987-04-10
K871069 MODIFIED HYSTEROSALPINGOGRAPY SET Ackrad Laboratories KNA Class II 1987-04-06
K863818 PM-100 THERMOGRAPH MARK 1026 Clearwater Computer Center, Inc. LHQ Class I 1987-04-03
K863797 BIOPSY NEEDLE GUIDE ATTACHMENT Elscint, Inc. HGL Class II 1987-03-27
K864151 280SL IMAGING SYSTEM TRANVAGINAL PROBES Ge Medical Systems Information Technologies HGL Class II 1987-03-27
K864578 ACUSON TV519 TRANSDUCER Acuson Computed Sonography HGL Class II 1987-03-27
K864219 TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE Amedic USA HGL Class II 1987-03-27
K870709 7.5 MHZ ENDOVAGINAL PROBE Philips Ultrasound, Inc. HGL Class II 1987-03-27
K864908 DIASONICS TRANSVAGINAL, TV 7.5 MHZ PROBE Diasonics, Inc. HGL Class II 1987-03-27
K871087 S.C.M.T. PERFORATOR Salt Creek Medical Technologies HGE Class I 1987-03-23
K871075 SCMT UMBILICAL CLAMP Salt Creek Medical Technologies HFW Class II 1987-03-23
K870539 O.B. SLENDER REGULAR TAMPON Personal Products Co. HEB Class II 1987-03-18
K870574 COSMEDTECH GENERAL ASPIRATOR Cosmedtech, Inc. HHI Class II 1987-03-05
K870046 DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET Tti Medical HHR Class II 1987-03-05
K864378 CO2 LASER MICROMANIPULATOR Transamerican Technologies Intl. HHR Class II 1987-03-05
K870550 TEFLON UTERINE SOUND Cook Ob/Gyn HHM Class I 1987-03-04
K862401 PERSONAL/DERBY CONDOMS Razi Corp. HIS Class II 1987-03-04
K864651 SUPER TAMPONS Tambrands, Inc. HEB Class II 1987-03-04
K864652 SUPER PLUS TAMPONS Tambrands, Inc. HEB Class II 1987-03-04
K870560 COSMEDTECH CANNULA Cosmedtech, Inc. HHI Class II 1987-03-04
K864648 SUPER PLUS PETAL SOFT PLASTIC APPLICATOR TAMPONS Tambrands, Inc. HEB Class II 1987-03-04
K864650 SLENDER REGULAR TAMPONS Tambrands, Inc. HEB Class II 1987-03-04
K864649 REGULAR PETAL SOFT PLASTIC APPLICATOR TAMPONS Tambrands, Inc. HEB Class II 1987-03-04
K864859 SUPER PETAL SOFT PLASTIC APPLICATOR TAMPAX TAMPONS Tambrands, Inc. HEB Class II 1987-03-04
K870551 INTRAUTERINE INSEMINATION CATHETER Cook Ob/Gyn HDR Class II 1987-03-02
K863221 OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN Laserscope HHR Class II 1987-03-02
K870745 STRYKER MODEL 977 BIRTHING BED Stryker Corp. KNC Class II 1987-02-27
K862873 IUC - INTRAUTERINE CATHETER Utah Medical Products, Inc. KXO Class II 1987-02-26
K870360 TAMPAX CLOSED-END FLUSHABLE TAMPON, SUPER PLUS Tambrands, Inc. HEB Class II 1987-02-25
K870361 TAMPAX CLOSED-END FLUSHABLE TAMPON, SLENDER REGU. Tambrands, Inc. HEB Class II 1987-02-25
K870398 PAP-PAK CYTOBRUSH KIT Medical Packaging Corp. HHT Class II 1987-02-25
K870358 TAMPAX CLOSED-END FLUSHABLE TAMPON, SUPER Tambrands, Inc. HEB Class II 1987-02-25
K870359 TAMPAX CLOSED-END FLUSHABLE TAMPON, ORIG. REGULAR Tambrands, Inc. HEB Class II 1987-02-25
K870446 DOLPHIN UMBILICAL CORD CLAMP Andermac, Inc. HFW Class II 1987-02-17
K864400 EXTRA STRONG CONDOM Ansell, Inc. HIS Class II 1987-02-02
K864524 SPERM SELECT(TM) Pharmacia, Inc. MQL Class II 1987-02-02
K864750 KOTEX SECURITY TAMPONS, REGULAR AND SUPER Kimberly-Clark Corp. HEB Class II 1987-01-28
K864498 O.B.(TM) TAMPON Personal Products Co. HIL Class II 1987-01-27
K864673 UNSCENTED MENSTRUAL PAD Procter & Gamble Mfg. Co. HHL Class II 1987-01-21
K864194 PALMER OBSTETRIC BRACE Ad-Tech Medical Instrument Corp KNC Class II 1987-01-14
K864623 OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT Xanmed Corp. KNA Class II 1987-01-14
K864323 CYTOLOGY BRUSHES Medical Packaging Corp. HHT Class II 1987-01-09
K864865 SPECULUM, VAGINAL, METAL FIBEROPTIC Luxtec Corp. HDG Class I 1987-01-09
K863610 THE OB-GYN CONCEPTS VAGINAL ASPIRATOR Ob/Gyn Concepts, Ltd. KOH Class I 1987-01-07
K861188 SPERM CAPACITATION MEDIUM Irvine Scientific HDR Class II 1987-01-06
K864570 PAMITEX,LONG LOVE,DESIRE,SKIN LESS,GINZA,LOVE TIME Dongkuk Techco Rubber Industries HIS Class II 1986-12-30
K863736 FMS MODEL 110 Flir Medical Systems IYM Class III 1986-12-29
K864482 CHOICE Select Sources, Inc. HIS Class II 1986-12-22
K863785 MAKLER CATHETER I M, Inc. HDR Class II 1986-12-11
K864187 KOTEX (R) GOODNITES Kimberly-Clark Corp. HHL Class II 1986-12-11
K861305 INTRAUTERINE CATHETER Ram Development HDR Class II 1986-12-11
K863190 CHOICE CONDOM Select Sources, Inc. HIS Class II 1986-12-03
K864473 SEMINAL FLUID COLLECTION KIT(TM) Apex Technologies, Inc. HIS Class II 1986-12-03
K863361 MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA Cooper Lasersonics, Inc. HHR Class II 1986-11-24
K862478 HAYES VAGINAL SHIELD Franklin Medical USA, Inc. HDF Class I 1986-11-24
K862861 SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE Directed Energy, Inc. HHR Class II 1986-10-27
K863520 CO2 LASER MICROMANIPULATOR Laser Spectrum, Inc. HHR Class II 1986-10-06
K863464 TAMPAX SUPER TAMPONS Tambrands, Inc. HEB Class II 1986-10-02
K860680 PROTEX, TAHITI CONDOM U. C. Import & Co. HIS Class II 1986-09-26
K863706 LOVESAFE CONTRACEPTIVE CONDOMS, TYPE NL-50 Manexim Multicorp, Ltd. HIS Class II 1986-09-26
K863707 LOVESAFE CONTRACEPTIVE CONDOMS, TYPE SC-40 Manexim Multicorp, Ltd. HIS Class II 1986-09-26
K863645 SCHULMAN DOUBLE UMBILICAL CORD CLAMP NO. 1000 United Medical Systems, Inc. HFW Class II 1986-09-25
K862444 FIBERLASE 100 MEDICAL LASER SYS/ND:YAG MENORRHAGIA Laser Media HHR Class II 1986-09-25
K860237 OMF-7101 FETAL MONITOR Nihon Kohden America, Inc. HGM Class II 1986-09-05
K863275 MARTIN MEDICAL PRO-SPEC SMALL VAGINAL SPECULUM Martin Medical HIB Class II 1986-09-02
K863274 MARTIN MEDICAL PRO-SPEC MEDIUM VAGINAL SPECULUM Martin Medical HIB Class II 1986-09-02
K862182 AMNIOINFUSION CATHETER Michael Reese Hospital and Medical Center KXO Class II 1986-08-25
K862228 CABOT LASER LAPAROSCOPY ACCESSORY SET Cabot Medical Corp. HHR Class II 1986-08-20
K860909 WORLDS BEST AND WORLDS BEST EXTRA SERIES (CONDOMS) U. C. Import & Co. HIS Class II 1986-08-19
K863145 CERVICAL SCRAPERS Surgipath Medical Industries, Inc. HHT Class II 1986-08-19
K862364 NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS) Swemed Laboratories, Inc. HEM Class II 1986-08-19
K862227 MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN Hgm, Inc. HHR Class II 1986-08-19
K862675 MODIFIED DEODORANT MAXITHINS PANTY SHIELDS Tambrands, Inc. HHL Class II 1986-08-18
K862676 MODIFIED SUPER DEODORANT MAXITHINS PADS Tambrands, Inc. HHL Class II 1986-08-15
K862680 MODIFIED REGULAR MAXITHINS PADS, UNSCENTED Tambrands, Inc. HHD Class I 1986-08-15
K862678 MODIFIED REGULAR DEODORANT MAXITHINS PADS Tambrands, Inc. HHL Class II 1986-08-15
K862677 MODIFIED MAXITHINS PANTY SHIELDS UNSCENTED Tambrands, Inc. HHD Class I 1986-08-15
K862679 MODIFIED SUPER MAXITHINS PADS, UNSCENTED Tambrands, Inc. HHD Class I 1986-08-15

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