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Obstetrics/Gynecology

4,608 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
ALATECH LATEX CONDOM (K993887)Alatech Healthcare, LLC1999-12-20
MENTOR EVACARE VAGINAL PESSARIES (K993308)Mentor Corp.1999-12-13
QUANTITATIVE SENTINEL SYSTEM (K993008)Marquette Medical Systems, Inc.1999-12-06
TYRODE'S SOLUTION-ACIDIFIED (K991339)Irvine Scientific Sales Co., Inc.1999-12-06
GYRUS HYSTEROSCOPIC RESECTOSCOPE (K993749)Gyrus Medical , Ltd.1999-12-03
LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN DISPLAY, HIGH FLOW INSUFFLATION TUBE WITH HEAT (K991906)Richard Wolf Medical Instruments Corp.1999-11-23
DR. JAHANGER'S CUTTER (K990738)M.S. Jahanger, MD1999-10-29
COOK ULTRA QUIET VACUUM PUMP & REGULATOR (K992070)Cook Urological, Inc.1999-10-27
TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM (K992544)Circon Corp.1999-10-26
GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195) (K992926)Ri Mos. S.R.L.1999-10-26
MODULAR INSTRUMENT SYSTEM FOR MINIMAL INVASIVE SURGERY (K990372)Dr. Fritz GmbH1999-10-14
CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C (K991563)Henke Sass Wolf of America, Inc.1999-10-13
WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM (K992736)Wallach Surgical Devices, Inc.1999-09-29
DISPOSABLE HEATING TUBING SET #7642HSES (K990662)Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh1999-09-24
PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM, GLUCOSE, PYRUVATE AND PHENOL RED (K991378)Sage Biopharma1999-09-24
PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA (K991381)Pacific Andrology, Inc.1999-09-24
MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES (K992480)Medifix, Inc.1999-09-23
CO2 GAS WARMER II, MODEL 6-800-00 (K992381)Northgate Technologies, Inc.1999-09-17
MODIFIED HAM'S F-10 BASAL MEDIUM, MODIFIED HAMS'S F-10 BASAL MEDIUM HEPES, MODIFIED HAM'S F-10 SUPPLEMENT (50X) IYOPHILI (K991419)Irvine Scientific Sales Co., Inc.1999-09-14
OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138 (K992308)Lifetek Medical, Inc.1999-09-13
EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER (K992307)Fertility Technology Resources, Inc.1999-09-13
ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M (K991388)Pacific Andrology, Inc.1999-09-13
DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO (K991799)Davol Inc., Sub. C. R. Bard, Inc.1999-09-13
<GEN>SINGLE LUMEN NEEDLE (K991262)<Genx> Intl., Inc.1999-09-09
<GENX> SINGLE LUMEN SIDEPORT NEEDLE (K991264)<Genx> Intl., Inc.1999-09-09
KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT UTERINE MANIPULATOR (K992027)Karl Storz Endoscopy1999-09-09
<GENX> DOUBLE LUMEN NEEDLE (K991020)<Genx> Intl., Inc.1999-09-09
<GENX> SPERM WASHING MEDIA (K991022)<Genx> Intl., Inc.1999-09-09
<GENX> EMBRYO TRANSFER CATHETER CC GLIDER (K991266)<Genx> Intl., Inc.1999-09-09
PATTON SPECULUM (K991963)Patton Medical Corp.1999-09-01
COROMETRICS MODEL 171 AND 172 FETAL MONITOR (K991905)General Electric Medical Systems Information Techn1999-09-01
O.B. TAMPON (K990536)Personal Products Co.1999-08-31
TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE (K992071)Ron-Tech Medical , Ltd.1999-08-27
VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL (K992081)Suretex Prophylactics (India) , Ltd.1999-08-19
COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR (K991739)General Electric Medical Systems Information Techn1999-08-19
TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR (K991892)Line One Laboratories1999-08-19
SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE (K991273)Swemed Lab International AB1999-08-18
FETALGARD 3000 FETAL MONITOR (K983395)Analogic Corp.1999-08-12
RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217) (K991895)Ri Mos. S.R.L.1999-08-12
HOFFMAN IVF-1 (K991216)(Arms) Hoffman Surgical Equipment, Ivf Division1999-08-05
ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET (K991261)Research Instruments , Ltd.1999-08-05
INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT) (K992438)Indus Medicare , Ltd.1999-08-02
WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N (K990348)CooperSurgical, Inc.1999-07-26
ENHANCE-S PLUS (K991322)Conception Technology, Inc.1999-07-26
WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST (K990349)CooperSurgical, Inc.1999-07-26
WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MODEL 2316 (K990350)CooperSurgical, Inc.1999-07-26
LAP-WAVE 3000 (P07) (K990732)W.O.M. World of Medicine GmbH1999-07-23
INSULSCAN INSULATION TESTING SYSTEM (K991424)Medicor Corp.1999-07-22
ANSELL CONDOMS (K984392)Ansell, Inc.1999-07-21
SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO (K991700)Swemed Lab International AB1999-07-19
MICROTOOLS (K991104)Conception Technology, Inc.1999-07-19
FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR (K991408)Thermoquest Corp.1999-07-19
GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043 (K991827)Ri Mos. S.R.L.1999-07-19
<GENX> FERTILIZATION MEDIA-HTF (K991173)<Genx> Intl., Inc.1999-07-19
SUMMER'S EVE LUBRICATING JELLY (K990597)C.B. Fleet Co., Inc.1999-07-19
NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L (K990941)Humagen Fertility Diagnostics, Inc.1999-07-14
BOVINE SERUM ALBUMIN (BSA) (K991338)Irvine Scientific Sales Co., Inc.1999-07-14
INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M (K990847)Humagen Fertility Diagnostics, Inc.1999-07-14
PVP (POLYVINYLPYRROLIDONE) (K991343)Irvine Scientific Sales Co., Inc.1999-07-14
PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION (K991342)Irvine Scientific Sales Co., Inc.1999-07-08
SPERM MAINTENANCE MEDIUM WITH GLYCEROL (K991337)Irvine Scientific Sales Co., Inc.1999-07-08
THERMOPLATE (K991263)Tokai Hit Co., Ltd.1999-07-08
ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION (K991341)Irvine Scientific Sales Co., Inc.1999-07-08
SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC) (K991235)Ludlow Technical Products1999-07-08
LIFESTYLES XTRA PLEASURE (K983518)Ansell, Inc.1999-07-06
MODIFIED HAM'S F-10 WITH ALBUMIN (K991420)Irvine Scientific Sales Co., Inc.1999-07-02
FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFRIGERATION MEDIUM - TEST YOLK BUFFER 9TYB) (K991421)Irvine Scientific Sales Co., Inc.1999-07-02
O.B. APPLICATOR TAMPONS, O.B. TAMPONS (K991118)Personal Products Co.1999-06-29
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 (K991229)Henning Knudsen Engineering A/S1999-06-29
ORIBRUSH - WITH PROTECTIVE TIP - B001 (K991595)Orifice Medical AB1999-06-29
ORIBRUSH - STANDARD - B002 (K991593)Orifice Medical AB1999-06-29
HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE) (K991047)Hardcover Products, Inc.1999-06-18
MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION) (K990925)Hardcover Products, Inc.1999-06-17
INVIGRA (K991374)Indus Medicare , Ltd.1999-06-15
CLIMAX (K991049)Medilatex Sdn. Bhd.1999-06-15
HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU (K990913)Laboratoires Prodimed1999-06-08
PRODIMED MICROINJECTION PIPETTES (K983713)Prodimed1999-06-08
MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS (K990910)Mtp Medical Technical Promotion GmbH1999-06-03
INTRA-UTERINE TRANSFER, INTRA-FOLOPIAN TRANSFER (K983604)Washington Regulatory Services1999-05-27
LACTATION TECHNIQUES MODEL B (K981549)Lactation Techniques, Inc.1999-05-24
BERACLAMP, MODEL BC-1 (K990045)Poamax LLC1999-05-24
PELVX INCONTINENCE DISH, MODEL 301-306 (K990593)Deschutes Medical Products, Inc.1999-05-24
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED) (K983840)Wallach Surgical Devices, Inc.1999-05-20
CVS PERSONAL LUBRICANT (K983216)San-Mar Laboratories, Inc.1999-05-17
MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9) (K990669)Dongkuk Techco Rubber Industries Sdn. Bhd.1999-05-17
MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE (K990411)Karl Storz Endoscopy1999-05-11
FALCON IVF ONE WELL DISH (K991251)Becton Dickinson Labware1999-05-05
FALCON IVF FOUR WELL PLATE (K991249)Becton Dickinson Labware1999-05-05
FALCON IVF ROUND DISH (K991253)Becton Dickinson Labware1999-05-05
EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP (K983776)Evenflo Co., Inc.1999-04-26
SPERM WASHING MEDIUM, MODIFIED SPERM WASHING MEDIUM (K983588)Irvine Scientific Sales Co., Inc.1999-04-26
SYNTHETIC SERUM SUBSTITUTE (SSS) (K983579)Irvine Scientific Sales Co., Inc.1999-04-23
ENDOMETRIAL SAMPLER (K990387)U.A. Medical Products, Inc.1999-04-20
BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771 (K990147)Richard Wolf Medical Instruments Corp.1999-04-16
'ECURLINE UMBILICAL CORD CLAMP #3500 (K990737)Precision Dynamics Corp.1999-04-06
DCI ENDOSCOPE (K990004)KARL STORZ Endoscopy-America, Inc.1999-04-02
HARWILL MEDICAL CERVITULA CERVICAL SPATULA (K983202)Harwill Medical (Pty) , Ltd.1999-03-15
MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS (K981955)Ls Rubber Sdn Bhd1999-03-15
GYNEX ELECTRODES (K982739)Gynex Corp.1999-03-12
MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS (K980964)Ls Rubber Sdn Bhd1999-03-12
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