meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
34
Latest Decision
1986-08-12

Clearances · page 41 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K861906 TAMPAX JUNIOR TAMPONS Tambrands, Inc. HEB Class II 1986-08-12
K861910 SUPER PETAL SOFT PLASTIC APPLICATOR TAMPAX TAMPONS Tambrands, Inc. HEB Class II 1986-08-12
K861911 SUPER PLUS PETAL SOFT PLASTIC APPLI. TAMPAX TAMPON Tambrands, Inc. HEB Class II 1986-08-12
K862310 CABOT MEDICAL VARIABLE FLOW INSUFFLATOR Cabot Medical Corp. HES Class II 1986-08-12
K861908 TAMPAX ORIGINAL REGULAR TAMPON Tambrands, Inc. HEB Class II 1986-08-12
K861913 SLENDER REGULAR TAMPAX TAMPONS Tambrands, Inc. HEB Class II 1986-08-12
K861909 REGULAR PETAL SOFT PLASTIC APPLI. TAMPAX TAMPONS Tambrands, Inc. HEB Class II 1986-08-12
K861907 TAMPAX SUPER TAMPONS Tambrands, Inc. HEB Class II 1986-08-12
K862456 ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION Cooper Lasersonics, Inc. HHR Class II 1986-08-12
K861912 SUPER PLUS TAMPAX TAMPONS Tambrands, Inc. HEB Class II 1986-08-12
K861845 MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE Directed Energy, Inc. HHR Class II 1986-08-11
K861513 LA DIFFUSION TECHNIQUE, KTY CM-10 BREAST PUMP Crystal Medical Products, Inc. HGX Class II 1986-08-08
K862931 MERIVAARA OBSTETRIC CHAIR/BED-MODEL 358 Global Medical Prods, Inc. KNC Class II 1986-08-07
K862627 SONORANGER TRANSVAGINAL PROBE Ausonics Pty , Ltd. HEM Class II 1986-08-01
K861858 VAGINAL CHAMBER PELLETHANE-MEDICAL GRADE 2363 Peritone Research, Ltd. HIR Class II 1986-07-31
K861931 645OB SECTOR/LINEAR ULTRASOUND SCANNER Ge Medical Systems Information Technologies HEM Class II 1986-07-31
K862410 MILEX KEGEL PERINEAL EXERCISER Milex Products, Inc. HIR Class II 1986-07-31
K862269 LAURIER SANTARY NAPKIN (MODIFICATION) Kao Corp. HHD Class I 1986-07-30
K861738 PLAYTEX TAMPONS Intl. Playtex, Inc. HIL Class II 1986-07-22
K861534 MODEL 450 INFRARED IMAGING SYSTEM Mitek , Inc. LHQ Class I 1986-07-18
K861544 MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM Hewlett-Packard Co. HGM Class II 1986-07-18
K862476 LS3000 CANNULA UTERINE SUCTION Engineering, Inc. HHI Class II 1986-07-18
K861371 TRANSVAGINAL PROBE, MODEL ED65M-TV Elscint, Inc. HGL Class II 1986-07-14
K862072 FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01 International Biomedics, Inc. HGL Class II 1986-07-09
K860933 AIR-CUSHION TOCOTONOMETER International Biomedics, Inc. HFM Class II 1986-07-09
K862353 TAMPAX TAMPONS, VARIOUS SIZES/TYPES (MODIFICATION) Tambrands, Inc. HIL Class II 1986-07-09
K854267 HUNTLEIGH DOPCORD, D140 Huntleigh Technology, Inc. KNG Class II 1986-07-09
K862285 KOTEX LIGHTDAYS DEODORANT PANTILINERS Kimberly-Clark Corp. HHL Class II 1986-07-08
K862322 CHLAMYDIA KIT, STD KIT Intl. Cytobrush, Inc. HHT Class II 1986-07-07
K861556 MODIFIED FETAL MONITOR MODEL FM-2 Advantage Medical Systems, Inc. HGM Class II 1986-07-07
K862358 EPICATH Hdc Corp. KNE Class II 1986-07-07
K862271 LAURIER SAFETY LONG SANITARY NAPKIN (MODIFICATION) Kao Corp. HHD Class I 1986-07-07
K862365 NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE Swemed Laboratories, Inc. HIO Class I 1986-07-07
K862270 LAURIER OVERNIGHT SANITARY NAPKIN (MODIFICATION) Kao Corp. HHD Class I 1986-07-07
K862297 THE D & C PAD-SAC Nu-Gyn-Tek, Inc. HCY Class I 1986-07-07
K862242 PAP SMEAR KIT Quali-Med, Inc. HHT Class II 1986-06-26
K861577 ACUSON S228, S519 & L558 TRANSDUCERS Acuson Computed Sonography HGL Class II 1986-06-19
K861578 ACUSON S328, L382, L538 & L312 TRANSDUCERS Acuson Computed Sonography HGL Class II 1986-06-17
K861385 MILEX BARTHOLIN GLAND CATHETER Milex Products, Inc. KNA Class II 1986-06-16
K854193 ELECTRO-MYOGRAPHIC PERINEOMETER Verimed Holdings, Inc. HIR Class II 1986-06-09
K861902 KOTEX PROFILE SHAPED MAXI PAD Kimberly-Clark Corp. HHD Class I 1986-06-09
K860233 5 MHZ INTRACAVITARY PROBE, MODEL H4222V General Electric Co. HEM Class II 1986-06-02
K861683 MONSANTO SANTOPRENE (PERITONE DEVICE) Peritone Research, Ltd. HIR Class II 1986-06-02
K861455 MODEL DT-102 DATA TELEPHONE TRANSMITTER Advantage Medical Systems, Inc. HGM Class II 1986-05-30
K860234 TRANSVAGINAL TRANSDUCER, 5MHZ Philips Medical Systems, Inc. HGL Class II 1986-05-23
K860621 1MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #507 Impex Medical Systems, Inc. HGL Class II 1986-05-20
K860295 FETASCAN 1500 International Biomedics, Inc. HGM Class II 1986-05-19
K861389 PAP SMEAR KIT Intl. Cytobrush, Inc. HHT Class II 1986-05-02
K861355 WHENEVER UNSCENTED REGULAR THIN MAXI-PADS Marcal Paper Mills, Inc. HHD Class I 1986-04-23
K861030 LABOR-DELIVERY STRETCH/BED Adel Medical , Ltd. KNC Class II 1986-04-23
K861357 WHENEVER UNSCENTED PANTY SHIELD Marcal Paper Mills, Inc. HHD Class I 1986-04-23
K861356 WHENEVER UNSCENTED SUPER THIN MAXI-PADS Marcal Paper Mills, Inc. HHD Class I 1986-04-23
K860552 PERITONE DISPOSAL SHEATH - RUBBER AND VINYL Laurie Ann Kaiser, Ph.D. HIR Class II 1986-04-17
K860101 MX4040 INTRAUTERINE PRESSURE MONITORING KIT Medex, Inc. KXO Class II 1986-04-14
K854622 PROPHYLACTIC (CONDOM) Medelec Intl. Corp. HIS Class II 1986-04-11
K861189 TECNOL SECURE-ALL FETAL MONITOR STRAP Tecnol New Jersey Wound Care, Inc. HGM Class II 1986-04-08
K860796 DISPO-URETTE Roland J. Zwick, Inc. PCF Class II 1986-04-08
K860445 CLAMP-N-CUT Mmi, Inc. HFW Class II 1986-04-04
K853216 MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4 Gyneco, Inc. HHK Class II 1986-04-02
K854725 HURWITZ AMNIOCENTESIS NEEDLE Bd Becton Dickinson Vacutainer Systems Preanalytic HIO Class I 1986-03-17
K860313 3.0 MHZ LINEAR ARRAY PROBE MODEL UST 5031 Johnson & Johnson Professionals, Inc. HGL Class II 1986-03-17
K860192 ENDOPORT 5MM SINGLE-USE TROCAR AND SLEEVE Endotherapeutics HET Class II 1986-03-17
K860294 HOSPITAL TABBED NAPKINS SUPER BELTED FEMININE NAPK I.C.D. Industries, Inc. HHD Class I 1986-03-13
K860587 KOTEX OVERNITE Kimberly-Clark Corp. HHD Class I 1986-03-13
K854415 ENDOMETRIAL PIPELLE Unimar, Inc. HHK Class II 1986-03-13
K853856 EXTERNAL UTERINE CONTRACTION MONITOR-TOKODYNAMOMET Aequitron Medical, Inc. HFM Class II 1986-03-12
K855044 PERINATAL COMPUTER SYS MODEL 100A & 100B Peritronics Research and Development, Inc. HGM Class II 1986-03-12
K852655 COMBISCOPE Instrument Technology, Inc. KNG Class II 1986-02-21
K853903 ENDO-LASE CD40 CO2 FOR GYNECOLOGY Endo Lase, Inc. HHR Class II 1986-02-21
K853876 ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY Endo Lase, Inc. HHR Class II 1986-02-21
K855093 MEDILAS 2 ND:YAG LASER SURGERY SYSTEM Endo Lase, Inc. HHR Class II 1986-02-21
K860329 FYODOROV RADIAL KERATOTOMY MARKER SET Med-Tech Develoment Corp. HHR Class II 1986-02-12
K852950 VISITHERM C.D. Regelin & Associates, Inc. IYM Class III 1986-02-07
K854470 PORTALASE 300 CARBON DIOXIDE SURG LASER GYNECOLOGI Minnesota Laser Corp. HHR Class II 1986-02-07
K854361 CO2 LASER LAPAROSCOPE SYSTEM Richard Wolf Medical Instruments Corp. HHR Class II 1986-02-04
K854247 JELLIA SKIN 1001 & LUBRICATED MILLION CONDOMS M/S Seohung Industrial Co., Ltd. HIS Class II 1986-01-16
K854595 P.A. MEDICAL VAGINAL IRRIGATION SET #1130 Pa Medical Corp. HED Class I 1986-01-13
K853257 SPECULITE DISPOSABLE VAGINAL LIGHT Trylon Associates, Ltd. HIC Class II 1985-12-27
K852680 TRITON LAPAROSCOPIC COAGULATOR INSUFFLATOR & LAVAG Multigon Industries, Inc. HET Class II 1985-12-23
K853711 5.0 MHZ INTRACAVITARY SECTOR PROBE General Electric Co. HEM Class II 1985-12-18
K852704 TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT Clincal Instruments Corp. HGM Class II 1985-11-26
K854258 PLAYTEX LIGHT'N GENTLE UNSCENTED/DEODORANT/MINI TA Intl. Playtex, Inc. HIL Class II 1985-11-21
K853326 WATER DRIVEN BREAST PUMP BY BABY NURSE Baby Nurse HGX Class II 1985-11-19
K853107 AXICARE CM-14 AUTOMATIC BREAST PUMP Crystal Medical Products, Inc. HGX Class II 1985-11-19
K853389 WALLACH ZOOM COLPOSCOPE Wallach Surgical Devices, Inc. HEX Class II 1985-11-19
K852460 GENTLE EXPRESSIONS AUTOMATIC BREAST PUMP & FEED SY Healthteam HGX Class II 1985-11-14
K851425 MODEL J25-25 WATT CO2 LASER Britt Corp., Inc. HHR Class II 1985-11-12
K853630 BELIEVE HEAVY FLOW PROTECTION LABIAL PADS Kimberly-Clark Corp. HHD Class I 1985-11-07
K852620 SAFE.N.SURE Ashai Co. , Ltd. HIS Class II 1985-10-31
K853640 WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL Downs Surgical , Ltd. HDF Class I 1985-10-29
K852980 OCS-2 COLPOSCOPE Olympus Corp. HEX Class II 1985-10-23
K852901 DOUBLE PUNCTURE INSTRUMENTS L.A.S.E.R., Inc. HET Class II 1985-10-16
K852694 PORTALASE 200 CARBON SURGICAL LASER SYSTEM Minnesota Laser Corp. HHR Class II 1985-09-30
K852608 SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM Ge Medical Systems Information Technologies HGM Class II 1985-09-27
K853407 INTRA VAGINAL TRANSDUCER Advanced Technology Laboratories, Inc. HEM Class II 1985-09-27
K851034 NOVATHERM Medtech Products, Inc. KXZ Class III 1985-09-27
K851902 MODEL U-1000 ULTRASONIC SCANNER Fukuda Denshi USA, Inc. HEM Class II 1985-09-27
K842422 KONTRON FAX FETAL MONITOR Kontron Instruments, Inc. HGM Class II 1985-09-20
K852721 BOZEMAN UTERINE FORCEPS, STRAIGHT, 10+410 0R 420 The Huxley Instrument Corp. HCZ Class II 1985-09-06
K852174 MERIVAARA OBSTETRIC CHAIR/BED MODEL 358 Daun International, Inc. KNC Class II 1985-09-06

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