meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
30
Latest Decision
2000-02-02

Clearances · page 23 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K991393 HYALURONIDASE, 80 U/ML Sage Biopharma MQL Class II 2000-02-02
K993781 SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED P.T. Vonix Latexindo Condom (Rubber) Mfg. HIS Class II 2000-02-02
K993782 SIMPLEX CONDOMS, LATEX CONDOMS-WITH SPERMICIDAL LUBRICANT (NONOXYNOL-9) P.T. Vonix Latexindo Condom (Rubber) Mfg. HIS Class II 2000-02-02
K993751 COROMETRICS MODEL 173 FETAL MONITOR Ge Medical Systems Information Technologies HGM Class II 2000-02-02
K993779 SIMPLEX CONDOMS, LATEX CONDOMS-FLAVORED AND LUBRICATED P.T. Vonix Latexindo Condom (Rubber) Mfg. HIS Class II 2000-02-02
K994263 SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540 Precision Dynamics Corp. HFW Class II 2000-01-24
K994418 VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) ETHICON, Inc. HIH Class II 2000-01-24
K990569 BABY DOPPLEX 4000, MODEL BD 4000 Huntleigh Healthcare, Inc. HGM Class II 2000-01-24
K992811 TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING Epic Medical Equipment Services, Inc. HFM Class II 2000-01-18
K994095 LATEX CONDOM Thai Nippon Rubber Industry Co., Ltd. HIS Class II 2000-01-18
K993870 UNSCENTED INTERLABIAL MENSTRUAL PAD Procter & Gamble Co. HHD Class I 2000-01-18
K992901 GYNECARE VERSAPOINT G-VAP ELECTRODE Gynecare, Inc. HIH Class II 2000-01-18
K991390 1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI Sage Biopharma MQL Class II 2000-01-18
K993411 FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL FS-HMTR Mega Electronics , Ltd. HIR Class II 2000-01-10
K991391 PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF Advanced Reproductive Technologies MQL Class II 2000-01-10
K993693 INVIGRA Indus Medicare , Ltd. HIS Class II 1999-12-29
K991441 CADENCE DOPPLER ULTRASOUND SYSTEM Medasonics, Inc. KNG Class II 1999-12-28
K990416 OMNICORDER BIOSCAN SYSTEM Omnicorder Technologies, Inc. LHQ Class I 1999-12-23
K993887 ALATECH LATEX CONDOM Alatech Healthcare, LLC HIS Class II 1999-12-20
K993308 MENTOR EVACARE VAGINAL PESSARIES Mentor Corp. HHW Class II 1999-12-13
K991339 TYRODE'S SOLUTION-ACIDIFIED Irvine Scientific Sales Co., Inc. MQL Class II 1999-12-06
K993008 QUANTITATIVE SENTINEL SYSTEM Marquette Medical Systems, Inc. HGM Class II 1999-12-06
K993749 GYRUS HYSTEROSCOPIC RESECTOSCOPE Gyrus Medical , Ltd. HIH Class II 1999-12-03
K991906 LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN DISPLAY, HIGH FLOW INSUFFLATION TUBE WITH HEAT Richard Wolf Medical Instruments Corp. HIF Class II 1999-11-23
K990738 DR. JAHANGER'S CUTTER M.S. Jahanger, MD KNA Class II 1999-10-29
K992070 COOK ULTRA QUIET VACUUM PUMP & REGULATOR Cook Urological, Inc. MQG Class II 1999-10-27
K992544 TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM Circon Corp. HEX Class II 1999-10-26
K992926 GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195) Ri Mos. S.R.L. HHK Class II 1999-10-26
K990372 MODULAR INSTRUMENT SYSTEM FOR MINIMAL INVASIVE SURGERY Dr. Fritz GmbH HET Class II 1999-10-14
K991563 CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C Henke Sass Wolf of America, Inc. HIH Class II 1999-10-13
K992736 WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM Wallach Surgical Devices, Inc. HIB Class II 1999-09-29
K991378 PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM, GLUCOSE, PYRUVATE AND PHENOL RED Sage Biopharma MQL Class II 1999-09-24
K990662 DISPOSABLE HEATING TUBING SET #7642HSES Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh HIF Class II 1999-09-24
K991381 PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA Pacific Andrology, Inc. MQL Class II 1999-09-24
K992480 MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES Medifix, Inc. HET Class II 1999-09-23
K992381 CO2 GAS WARMER II, MODEL 6-800-00 Northgate Technologies, Inc. HIF Class II 1999-09-17
K991419 MODIFIED HAM'S F-10 BASAL MEDIUM, MODIFIED HAMS'S F-10 BASAL MEDIUM HEPES, MODIFIED HAM'S F-10 SUPPLEMENT (50X) IYOPHILI Irvine Scientific Sales Co., Inc. MQL Class II 1999-09-14
K992308 OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138 Lifetek Medical, Inc. MQE Class II 1999-09-13
K991388 ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M Pacific Andrology, Inc. MQH Class II 1999-09-13
K991799 DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO Davol Inc., Sub. C. R. Bard, Inc. HIG Class II 1999-09-13
K992307 EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER Fertility Technology Resources, Inc. MQF Class II 1999-09-13
K991262 <GEN>SINGLE LUMEN NEEDLE <Genx> Intl., Inc. MQE Class II 1999-09-09
K991022 <GENX> SPERM WASHING MEDIA <Genx> Intl., Inc. MQL Class II 1999-09-09
K991264 <GENX> SINGLE LUMEN SIDEPORT NEEDLE <Genx> Intl., Inc. MQE Class II 1999-09-09
K992027 KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT UTERINE MANIPULATOR Karl Storz Endoscopy HIH Class II 1999-09-09
K991020 <GENX> DOUBLE LUMEN NEEDLE <Genx> Intl., Inc. MQE Class II 1999-09-09
K991266 <GENX> EMBRYO TRANSFER CATHETER CC GLIDER <Genx> Intl., Inc. MQF Class II 1999-09-09
K991905 COROMETRICS MODEL 171 AND 172 FETAL MONITOR General Electric Medical Systems Information Techn HGM Class II 1999-09-01
K991963 PATTON SPECULUM Patton Medical Corp. HIB Class II 1999-09-01
K990536 O.B. TAMPON Personal Products Co. HEB Class II 1999-08-31
K992071 TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE Ron-Tech Medical , Ltd. HDC Class II 1999-08-27
K992081 VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL Suretex Prophylactics (India) , Ltd. HIS Class II 1999-08-19
K991892 TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR Line One Laboratories HIS Class II 1999-08-19
K991739 COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR General Electric Medical Systems Information Techn HGM Class II 1999-08-19
K991273 SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE Swemed Lab International AB MQE Class II 1999-08-18
K991895 RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217) Ri Mos. S.R.L. HHK Class II 1999-08-12
K983395 FETALGARD 3000 FETAL MONITOR Analogic Corp. HGM Class II 1999-08-12
K991216 HOFFMAN IVF-1 (Arms) Hoffman Surgical Equipment, Ivf Division MQG Class II 1999-08-05
K991261 ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET Research Instruments , Ltd. MQH Class II 1999-08-05
K992438 INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT) Indus Medicare , Ltd. LTZ Class II 1999-08-02
K990348 WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N CooperSurgical, Inc. MQF Class II 1999-07-26
K991322 ENHANCE-S PLUS Conception Technology, Inc. MQL Class II 1999-07-26
K990349 WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST CooperSurgical, Inc. MQF Class II 1999-07-26
K990350 WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MODEL 2316 CooperSurgical, Inc. MQF Class II 1999-07-26
K990732 LAP-WAVE 3000 (P07) W.O.M. World of Medicine GmbH HET Class II 1999-07-23
K991424 INSULSCAN INSULATION TESTING SYSTEM Medicor Corp. HFG Class II 1999-07-22
K984392 ANSELL CONDOMS Ansell, Inc. HIS Class II 1999-07-21
K991408 FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR Thermoquest Corp. MQG Class II 1999-07-19
K991173 <GENX> FERTILIZATION MEDIA-HTF <Genx> Intl., Inc. MQL Class II 1999-07-19
K991827 GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043 Ri Mos. S.R.L. HIB Class II 1999-07-19
K991700 SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO Swemed Lab International AB MQH Class II 1999-07-19
K991104 MICROTOOLS Conception Technology, Inc. MQH Class II 1999-07-19
K990597 SUMMER'S EVE LUBRICATING JELLY C.B. Fleet Co., Inc. HIS Class II 1999-07-19
K990847 INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M Humagen Fertility Diagnostics, Inc. MQH Class II 1999-07-14
K991338 BOVINE SERUM ALBUMIN (BSA) Irvine Scientific Sales Co., Inc. MQL Class II 1999-07-14
K990941 NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L Humagen Fertility Diagnostics, Inc. MQK Class II 1999-07-14
K991343 PVP (POLYVINYLPYRROLIDONE) Irvine Scientific Sales Co., Inc. MQL Class II 1999-07-14
K991263 THERMOPLATE Tokai Hit Co., Ltd. MQG Class II 1999-07-08
K991341 ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION Irvine Scientific Sales Co., Inc. MQL Class II 1999-07-08
K991342 PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION Irvine Scientific Sales Co., Inc. MQL Class II 1999-07-08
K991337 SPERM MAINTENANCE MEDIUM WITH GLYCEROL Irvine Scientific Sales Co., Inc. MQL Class II 1999-07-08
K991235 SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC) Ludlow Technical Products KXO Class II 1999-07-08
K983518 LIFESTYLES XTRA PLEASURE Ansell, Inc. HIS Class II 1999-07-06
K991421 FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFRIGERATION MEDIUM - TEST YOLK BUFFER 9TYB) Irvine Scientific Sales Co., Inc. MQL Class II 1999-07-02
K991420 MODIFIED HAM'S F-10 WITH ALBUMIN Irvine Scientific Sales Co., Inc. MQL Class II 1999-07-02
K991118 O.B. APPLICATOR TAMPONS, O.B. TAMPONS Personal Products Co. HEB Class II 1999-06-29
K991593 ORIBRUSH - STANDARD - B002 Orifice Medical AB HHT Class II 1999-06-29
K991229 K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E,L Henning Knudsen Engineering A/S MQG Class II 1999-06-29
K991595 ORIBRUSH - WITH PROTECTIVE TIP - B001 Orifice Medical AB HHT Class II 1999-06-29
K991047 HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE) Hardcover Products, Inc. LTZ Class II 1999-06-18
K990925 MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION) Hardcover Products, Inc. HIS Class II 1999-06-17
K991374 INVIGRA Indus Medicare , Ltd. HIS Class II 1999-06-15
K991049 CLIMAX Medilatex Sdn. Bhd. HIS Class II 1999-06-15
K990913 HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU Laboratoires Prodimed MQE Class II 1999-06-08
K983713 PRODIMED MICROINJECTION PIPETTES Prodimed MQH Class II 1999-06-08
K990910 MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS Mtp Medical Technical Promotion GmbH HIH Class II 1999-06-03
K983604 INTRA-UTERINE TRANSFER, INTRA-FOLOPIAN TRANSFER Washington Regulatory Services MQF Class II 1999-05-27
K990045 BERACLAMP, MODEL BC-1 Poamax LLC KNA Class II 1999-05-24
K990593 PELVX INCONTINENCE DISH, MODEL 301-306 Deschutes Medical Products, Inc. HHW Class II 1999-05-24
K981549 LACTATION TECHNIQUES MODEL B Lactation Techniques, Inc. HGX Class II 1999-05-24

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