meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
39
Latest Decision
1981-07-16

Clearances · page 45 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K811568 CERVICAL DILATOR Gynemetrics, Inc. HDQ Class I 1981-07-16
K811660 PLAYTEX MODIFIED FIBER TAMPONS Playtex, Inc. HIL Class II 1981-07-16
K811869 UNSCENTED MENSTRUAL PADS Procter & Gamble Mfg. Co. HHD Class I 1981-07-16
K810569 CONTACT-MICRO COLPOHYSTEROSCOPE KARL STORZ Endoscopy-America, Inc. HIH Class II 1981-07-16
K810115 DOPPLEX-PLB & PXB Huntleigh Technology, Inc. KNG Class II 1981-07-16
K811868 SCENTED MENSTRUAL PADS Procter & Gamble Mfg. Co. HHL Class II 1981-07-16
K810697 AXISONIC II Teknar, Inc. HDR Class II 1981-07-13
K811766 CONFI-DRY ADULT UROABSORBENT PADS Personal Products Co. HHD Class I 1981-07-10
K811386 PLAYTEX PROCESS MACHINERY CHANGE Playtex, Inc. HIL Class II 1981-07-10
K811520 GRAYLINE IMAGING SYSTEM Sonics Research Corp. HEM Class II 1981-07-02
K811548 CERVICAL SPATULA Procedure Products, Inc. HHT Class II 1981-06-23
K811403 AXICARE BREAST PUMP MODEL Neonatal Corp. HGX Class II 1981-06-12
K811214 ASSURE NATURAL FIT TAMPON Personal Products Co. HIL Class II 1981-05-21
K810886 ADEL MEDICAL BIRTHING BED, #LD-500 Adel Medical , Ltd. HDD Class II 1981-04-23
K810558 SKIN SCRUB TRAY Associated Medical Products Co. HFD Class II 1981-03-17
K810562 CARBON DIOXIDE (C02) MICROSURGICAL LASER Metricon, Ltd. HHR Class II 1981-03-17
K810305 DATASON DB ULTRASOUND IMAGING SYSTEM General Electric Co. HEM Class II 1981-03-13
K810484 OVARY FORCEPS American V. Mueller KNA Class II 1981-03-11
K810483 FALLOPIAN TUBE FORCEPS American V. Mueller KNA Class II 1981-03-11
K810391 VOGLER HYSTERECTOMY FORCEPS (SMALL & LG) Edward Weck, Inc. HCZ Class II 1981-03-04
K810143 TAMPAX DEODORANT TAMPONS Tampax, Inc. HIL Class II 1981-03-04
K803250 TASSAWAY Plastic Applications, Inc. HHE Class II 1981-02-12
K810100 BREAST PUMP American Hospital Supply Corp. HGY Class I 1981-02-12
K810065 SCOTT CM42 PASTEURIZER William Harvey Life Products Corp. HGX Class II 1981-01-28
K803210 MENSTRUAL ASPIRATION KITS Gynemetrics, Inc. HHK Class II 1981-01-28
K810160 TAMPAX MAXITHINS PADS Tampax, Inc. HHD Class I 1981-01-28
K810028 FETAL BLOOD SAMPLING KIT MODEL 1560 Transidyne General Corp. HGW Class II 1981-01-16
K802313 UTERINE CURETTE Gynemetrics, Inc. HCY Class I 1981-01-12
K802457 KEVORKIAN-YOUNGE BIOPSY PUNCH, #90-6610 J. Sklar Mfg. Co., Inc. HFB Class I 1981-01-12
K802458 KEVORKIAN-YOUNGE BIOPSY CURETTE #90-6611 J. Sklar Mfg. Co., Inc. HFB Class I 1981-01-12
K802760 PETAL SOFT PLASTIC APPLICATOR TAMPAX Tampax, Inc. HEB Class II 1981-01-12
K802315 UTERINE SOUND Gynemetrics, Inc. HHM Class I 1981-01-12
K802024 GRAVIDAPHONE Solar Electronics KNG Class II 1981-01-07
K802666 APTEK ULTRASOUND PROCEDURE TRAY Aptek , Ltd. HIO Class I 1980-11-26
K802193 KOTEX SECURITY TUBE TAMPONS Kimberly-Clark Corp. HEB Class II 1980-11-12
K801553 THERMOCOMP Hospital Financial Corp. IYM Class III 1980-10-31
K802139 SPATULA, CERVICAL CYTOLOGICAL CYTOLOGY Dyn-A-Med Products HHT Class II 1980-10-31
K802360 UTERINE VACUM ASPIRATING CURRETTE American Hospital Supply Corp. HHI Class II 1980-10-31
K801862 MEDELA ELECTRIC BREAST PUMP Medela, Inc. HGX Class II 1980-10-23
K802277 KOTEX LIGHTDAYS DEODORANT PANTILINERS Kimberly-Clark Corp. HHL Class II 1980-10-10
K800956 DOUCH TRAY-DISPOSABLE VAGINAL TRAY W/BEN The Healthcare Group Laboratories, Inc. HED Class I 1980-10-03
K801246 OXFORD HUMAN MILK PASTEURISER Vickers America Medical Corp. HGX Class II 1980-10-03
K800954 DOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVID The Healthcare Group Laboratories, Inc. HED Class I 1980-10-03
K801984 FE-3000 FETAL ELECTRODE, SPIRAL SYSTEM Life Support, Inc. HGP Class II 1980-09-09
K801758 MMI/GAELTEC CATHETER INTRAUTERINE Medical Measurements, Inc. KXO Class II 1980-08-14
K801622 ADEL MEDICAL BIRTHING BED, MOD. LD-400 Adel Medical , Ltd. KNC Class II 1980-08-14
K801747 TERUMO FETAL MONITOR # FHM-602 Terumo Medical Corp. HGM Class II 1980-08-13
K801730 KRYMED SYSTEM 4001 TILT SCOPE Cryomedics, Inc. HEX Class II 1980-08-13
K801238 ACCU-PAP T ZONE SAMPLER Robert Hasselbrack, M.D. HFC Class II 1980-08-12
K801024 ODOR MASKING AGENT IN BOUNDARY OBSTETRI. The Buckeye Cellulose Corp. HHL Class II 1980-07-28
K801358 NEW FREEDOM ANYDAY PANTILINERS Kimberly-Clark Corp. HHL Class II 1980-07-21
K801070 SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES Sherwood Medical Industries HHK Class II 1980-07-21
K800957 DOUCHE UNIT-1500 ML DISP. CONTAINER The Healthcare Group Laboratories, Inc. HED Class I 1980-07-14
K801197 CO2 LASER Advanced Biomedical Instruments HHR Class II 1980-06-30
K800834 SER-TEX V.S.S.I., Inc. KOH Class I 1980-06-30
K800858 FETAL HEART DETECTOR #'S D102 & D102R Sonicaid, Inc. KNG Class II 1980-05-14
K800833 VABRA ASPIRATOR Cooper Medical Devices Corp. HHI Class II 1980-05-14
K800859 FETAL HEART DETECTOR #D206 Sonicaid, Inc. KNG Class II 1980-05-14
K800777 TAMPAX TAMPONS Tampax, Inc. HEB Class II 1980-05-14
K800952 PAPER-PAK OB PADS Paper-Pak Products, Inc. HHD Class I 1980-05-14
K800668 CANNULA, W/SHARP OBTURATOR & VERESS NEED KARL STORZ Endoscopy-America, Inc. HET Class II 1980-05-08
K800874 PELVIC EXAM TRAY Pharmaseal Laboratories HHD Class I 1980-05-08
K800747 BELTLESS MAXI, MINI & SUPER MAXI PADS Dafoe & Dafoe, Inc. HHD Class I 1980-04-29
K800191 PERITONE Laurie Ann Kaiser, Ph.D. HIR Class II 1980-04-16
K800518 UTAGE-MATSU-MICRO-THIN UTAGE-SAKURA, Kopharm, Inc. HIS Class II 1980-03-20
K800013 FETAL MONITOR MODEL FHM-1 Advantage Medical Systems, Inc. HGM Class II 1980-03-07
K800491 GRAPHIC STRESS TELETHERMOMETRY Gst Laboratories of Ca, Inc. IYM Class III 1980-03-04
K800227 ML-800 CO2 Merrimack Laboratories HHR Class II 1980-03-03
K800303 ELECTRONIC PERINEOMETER Associates IN Biofeedback HIR Class II 1980-03-03
K800372 SANITARY NAPKINS, MAXI 30'S Giant Eagle Markets, Inc. HHD Class I 1980-03-03
K800185 SANITARY NAPKINS MAXI-30 No Frills Discount Foods, Inc. HHD Class I 1980-03-03
K791330 HYSTEROSER A. B. Vacuum Extractor, Inc. HIH Class II 1980-03-03
K800272 RELY DEODERANT TAMPON Procter & Gamble Mfg. Co. HIL Class II 1980-02-26
K800098 MINIFETON 200 Kt Medical, Inc. KNG Class II 1980-02-11
K800162 ONCE TM G.D. Searle and Co. HDW Class II 1980-02-11
K800095 MGD-3 Kt Medical, Inc. KNG Class II 1980-02-11
K792669 COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE Ge Medical Systems Information Technologies HGP Class II 1980-02-11
K792627 STERILIZATION PROCESS/MATERNITY PAD Procter & Gamble Mfg. Co. HIL Class II 1980-01-28
K792631 STERILIZATION PROCESS/DBL. GRIP CORD CLP Procter & Gamble Mfg. Co. KNA Class II 1980-01-28
K792568 OBSTETRICAL BEDS Ets Rene Marzet KNC Class II 1980-01-28
K792634 CONCEPTROL/THIN PROPHYLACTICS Ortho Pharmaceutical Corp. HIS Class II 1980-01-16
K792296 SANITARY/OB PAD American Hospital Supply Corp. HHD Class I 1979-12-13
K792195 DEODORANT CAREFREE PANTY SHIELDS Personal Products Co. HHL Class II 1979-11-16
K791765 MASTERSON* ENDOMETRIAL BIOPSY KIT Codman & Shurtleff, Inc. HHK Class II 1979-11-05
K790433 NATURDOM Juan C. Lucena HIS Class II 1979-10-04
K791279 KOLPOSKOP KP20005 Elmed, Inc. HEX Class II 1979-09-17
K791433 KOTEX LIGHTDAYS DEODORANT PATILINERS Kimberly-Clark Corp. HHL Class II 1979-09-17
K791633 UC-2000 UTERINE CATHERIZATION SYSTEM Life Support, Inc. HFO Class II 1979-09-17
K791036 FETASONDE UTERINE WORK MONITOR Roche Medical Electronics, Inc. HGM Class II 1979-09-04
K791039 FETASONDE FETAL HEART RATE VARIABILITY Roche Medical Electronics, Inc. HGM Class II 1979-09-04
K791035 FETASONDE FETAL ACTIVITY MONITOR Roche Medical Electronics, Inc. HGM Class II 1979-09-04
K791037 FETASONDE LABOR STATUS DISPLAY Roche Medical Electronics, Inc. HGM Class II 1979-09-04
K791038 FETASONDE UTERINE ACTIVITY MONITOR Roche Medical Electronics, Inc. HGM Class II 1979-09-04
K791277 MODEL 6500 EXTRACTION IRRIGATION SYS Cavitron Corp. HDQ Class I 1979-08-22
K790950 S/A 7800 BIRTH SUPPORT CHAIR Schlosser Alberti Co. KNC Class II 1979-08-03
K790951 SA/7860 FETAL HEART MONITOR (DOPPLER) Schlosser Alberti Co. KNG Class II 1979-08-03
K791274 RELY TAMPON Procter & Gamble Mfg. Co. HEB Class II 1979-08-03
K791052 ENDOSCOPIC INSTRUMENT Eder Instrument Co, Inc. HET Class II 1979-08-03
K790853 EASY-SPEC C. Intl. KNA Class II 1979-07-30
K790852 VAGI-SPEC C. Intl. KNA Class II 1979-07-30

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