meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
27
Latest Decision
1988-06-01

Clearances · page 39 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K880591 LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE Laser Peripherals, LLC HHR Class II 1988-06-01
K880900 SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER Corometrics Medical Systems, Inc. HEM Class II 1988-06-01
K880988 PUDENDAL/LOCAL ANESTESIA BLOCK TRAY Bd Becton Dickinson Vacutainer Systems Preanalytic KNE Class II 1988-06-01
K880930 MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE Copper Lasersonics, Inc. HHR Class II 1988-05-31
K880991 LASER OPTICAL CATHETER SYSTEM Medline Industries, Inc. HHR Class II 1988-05-25
K880763 NEZHAT IRRIGATION PUMP SYSTEM Cabot Medical Corp. HET Class II 1988-05-24
K881312 LAMINARIA Busse Hospital Disposables, Inc. HDY Class II 1988-05-23
K874921 HEADFIRST (CONDOM) Stual Products, Inc. HIS Class II 1988-05-13
K875068 AIDS SAFETY BELT Aids Safety Belt, Inc. HIS Class II 1988-05-10
K880196 LAMINARIA Medgyn Products, Inc. HDY Class II 1988-05-06
K880753 UMBILICAL CORD CLAMP I M, Inc. HFW Class II 1988-04-27
K880734 SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS Personal Products Co. HHI Class II 1988-04-25
K880735 UNSCENTED MENSTRUAL PADS Personal Products Co. HHD Class I 1988-04-25
K881010 CO2 RIGID LASER ENDOSCOPE PROBE SERIES 792/LAPARO Sharplan Lasers, Inc. HET Class II 1988-04-21
K871267 BLAUSIEGEL TRANSPARENT CONDOMS Ticosan, Inc. HIS Class II 1988-04-12
K874791 CONDOMS (RAMSES EXTRA, SHEIK ELITE AND KOROMEX) Schmid Laboratories, Inc. HIS Class II 1988-04-12
K875300 MEDELA BREAST-PUMP LACTINA Medela, Inc. HGX Class II 1988-04-06
K872356 CONDOMS (HOMBRE BLACK/BLACK SATIN/XT-12/ORION) Mayer Laboratories HIS Class II 1988-04-06
K874399 SAFECON CONDOMS Quality Synthetics Intl, Inc. HIS Class II 1988-04-06
K874668 SPERM WASHING MEDIUM #9983 & MODIFIED #9984 Irvine Scientific HDR Class II 1988-03-31
K875371 KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM Kontron Instruments, Inc. HGL Class II 1988-03-24
K875334 KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM Kontron Instruments, Inc. HGL Class II 1988-03-24
K880173 MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION Cooper Lasersonics, Inc. HHR Class II 1988-03-24
K880497 WORD BARTHOLIN GLAND CATHETER CODE: 1005 Hoosier Specialties, Inc. KNA Class II 1988-03-24
K881057 PLAYTEX PORTABLE NON-DEOD. & DEOD REGULAR & SUPER Playtex, Inc. HIL Class II 1988-03-22
K880195 GYNESCOPE Medgyn Products, Inc. HEX Class II 1988-03-14
K874837 KTP/532 LASER FOR OB-GYN USE Laserscope HHR Class II 1988-03-14
K875309 SANITARY MENSTRUAL NAPKIN Universal Health Care Products Canada, Inc. HHD Class I 1988-03-14
K874631 HEALTHPHONE TOCO MODEL Carelink HFM Class II 1988-03-11
K873150 PDS, MODEL NST 40 FETAL MONITOR, RECORDER & TRANS. Pediatric Diagnostic Service HFM Class II 1988-03-11
K871744 CONTATTO CONDOMS Razi Corp. HIS Class II 1988-03-09
K880024 TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER PLUS Tambrands, Inc. HIL Class II 1988-03-08
K874383 MENTOR PLUS (CONDOM) Arcon Corp. HIS Class II 1988-03-07
K880022 TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER TAMPON Tambrands, Inc. HIL Class II 1988-03-02
K875137 LAPAROFLATOR 3000, STANDARD AND ELECTRONIC F.M. Wiest USA, Inc. HES Class II 1988-03-02
K880023 TAMPAX COMPAK, COMPACT PLASTIC APPLI. REGU. TAMPON Tambrands, Inc. HIL Class II 1988-03-02
K873527 DECHERNEY HYSTEROSCOPY PUMP SYSTEM Cabot Medical Corp. HIG Class II 1988-02-26
K875111 RUBBER CONTRACEPTIVE, LATEX CONDOMS Okamoto USA, Inc. HIS Class II 1988-02-26
K880202 OKAMOTO CONDOMS Schmid Laboratories, Inc. HIS Class II 1988-02-26
K875078 HERACURE LS 500 W.C. Heraeus GmbH HHR Class II 1988-02-22
K875084 CABOT MEDICAL ENDOMETRIAL SUCTION CURETTE Cabot Medical Corp. HHK Class II 1988-02-08
K870653 ULTRASOUND LINEAR/SECTOR SCANNER 1100 Pie Data Medical BV KNG Class II 1988-02-02
K870841 MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN Directed Energy, Inc. HHR Class II 1988-02-02
K872709 MODEL 20-C, RL-20A/U, OB-10A/U Directed Energy, Inc. HHR Class II 1988-02-02
K870058 PIE MEDICAL SCANNER 1000 Pie Data Medical BV KNG Class II 1988-02-02
K873115 CABOT FIBER LASER PROBE Cabot Medical Corp. HET Class II 1988-01-28
K864946 ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE Bio Quantum Technologies, Inc. HHR Class II 1988-01-28
K875162 ORTHO* SPECIMEN COLLECTION CYTOLOGY BRUSH Ortho Diagnostic Systems, Inc. HHT Class II 1988-01-27
K874851 XL-4 PAGODA (CONDOMS) Mayer Laboratories HIS Class II 1988-01-21
K874610 ADEL MODEL 2100 BIRTHING BED Adel Medical , Ltd. HDD Class II 1988-01-21
K873598 LASER LAPAROSCOPY SET Cuda Products Co. HET Class II 1988-01-20
K874135 CONDOM (PROPHYLACTIC) Pactec, Inc. HIS Class II 1988-01-19
K873457 SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS Procter & Gamble Mfg. Co. HIL Class II 1988-01-19
K874509 PLAYTEX NON & DEODORANT TAMPONS + PRIVATE LABEL Playtex, Inc. HIL Class II 1988-01-07
K874604 HISTOBRUSH Spectrum Co. HHT Class II 1988-01-07
K872265 ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE. Labsonics, Inc. HGL Class II 1988-01-04
K872352 FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIA Laser Media HHR Class II 1987-12-30
K872254 SLT CONTACT ND:YAG LASER FOR INTRA-ABDOM.&GENITAL Surgical Laser Technologies, Inc. HHR Class II 1987-12-14
K872861 LOVIEL CONDOM Lloviel Marketing Corp. HIS Class II 1987-12-11
K874718 STANDARD LATEX CONDOMS (RAMSES, SHEIK AND KOROMEX) Schmid Laboratories, Inc. HIS Class II 1987-12-08
K874071 MOTHER'S MILK BAG Yanase Waitch K.K. HGX Class II 1987-12-08
K871451 BESTCON/SPERMICIDE Europharmaceutical Corp. HIS Class II 1987-12-08
K872799 KIMONO (CONDOMS) Mayer Laboratories HIS Class II 1987-12-08
K873552 CANNULA AND GENERAL PURPOSE ASPIRATOR Cosmedtech, Inc. HHI Class II 1987-11-25
K871928 CARBON DIOXIDE INSUFFLATOR/LAPARO & HI FLOW LASER/ Medline Industries, Inc. HIF Class II 1987-11-23
K872504 LUBRICATED CONDOM Royal American Industries, Inc. HIS Class II 1987-11-20
K874464 SPERMICIDAL CONDOM Royal American Industries, Inc. HIS Class II 1987-11-20
K871579 MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE Sharplan Lasers, Inc. HHR Class II 1987-11-16
K872860 INSUFFLATOR TUBING Medline Industries, Inc. HIG Class II 1987-11-16
K872057 FETAL SCALP ELECTRODE Medical Accessories, Inc. HGP Class II 1987-11-16
K872812 SKINLESS-SKIN, PINK TINT (CONDOM) Okamoto USA, Inc. HIS Class II 1987-11-05
K872664 SKINLESS SKIN-HARMONY CONDOMS Okamoto USA, Inc. HIS Class II 1987-11-05
K872619 PREVENTETTE (CONDOM) Reb Enterprises, Inc. HIS Class II 1987-11-04
K872005 MAXIMUM, LATEX PROPHYLACTIC BRAND Safe Product Supplies HIS Class II 1987-11-02
K872962 BREAST-SCAN(TM) Thermascan, Inc. LHM Class I 1987-10-20
K871948 ANGEL LATEX PROPHYLACTICS (CONDOMS) Angel Intl. Trading Co., Inc. HIS Class II 1987-10-20
K871036 CONDOM TAKASO RUBBER PRODUCTS SDN/BDH Takaso Rubber C/O Interstate Supplier, Inc. HIS Class II 1987-10-20
K872908 ENDOMETRIAL SAMPLER Zinnanti Surgical Instruments, Inc. HHK Class II 1987-10-20
K872736 PROPHYLACTIC (CONDOM) Circle Rubber Corp. HIS Class II 1987-10-20
K872253 CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIA Surgical Laser Technologies, Inc. HHR Class II 1987-10-06
K873515 UTERINE INJECTOR 2MM Zinnanti Surgical Instruments, Inc. HES Class II 1987-09-29
K872849 SPERM-SELECT ADDITIONAL INDICATION Pharmacia, Inc. HDR Class II 1987-09-28
K871856 ANNULAR ARRAY SCANHEAD Advanced Technology Laboratories, Inc. HGL Class II 1987-08-28
K872088 FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL) Irvine Scientific HDR Class II 1987-08-14
K872203 CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER) Irvine Scientific HDR Class II 1987-08-14
K871470 BESTCON/LUBRICATED CONDOMS Europharmaceutical Corp. HIS Class II 1987-08-05
K871681 PHOTOSTAR V-8 Wallach Surgical Devices, Inc. HEX Class II 1987-08-05
K872481 LAURIER NIGHT SAFE EXTRA PROTECTION SANITARY NAP. Kao Corp. HHD Class I 1987-08-05
K871683 COLPOSTAR V-6 Wallach Surgical Devices, Inc. HEX Class II 1987-08-05
K872287 LADY FREE UNSCENTED MENSTRUAL PAD American Tissue Corp. HHD Class I 1987-08-05
K871082 FETAL CARE MONITOR ANTEPARTUM 1500 Pie Data Medical BV HGM Class II 1987-08-04
K871020 KANGLE CONDOM Lindley Company, Inc. HIS Class II 1987-07-21
K871220 MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI. Cooper Lasersonics, Inc. HHR Class II 1987-07-16
K872102 SPERM WASHING MEDIUM #9932 Irvine Scientific HDR Class II 1987-07-16
K871577 HTF MEDIUM AND MODIFIED HTF MEDIUM-HEPES Irvine Scientific HDR Class II 1987-07-15
K872261 TAMPAX DEODORANT TAMPON, SUPER Tambrands, Inc. HIL Class II 1987-07-14
K871079 FETALFLEX FETAL ELECTRODE Epcom Medical Systems, Inc. HGP Class II 1987-07-13
K871960 ELECTRO-GYNE ELECTROSURGICAL GENERATOR Cabot Medical Corp. KNF Class II 1987-07-10
K872257 TAMPAX PETAL SOFT DEODORANT TAMPON, REGULAR Tambrands, Inc. HIL Class II 1987-07-10
K872259 TAMPAX PETAL SOFT DEODORANT TAMPON, SUPER Tambrands, Inc. HIL Class II 1987-07-10

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