meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
36
Latest Decision
1999-05-20

Clearances · page 24 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K983840 WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED) Wallach Surgical Devices, Inc. HGI Class II 1999-05-20
K990669 MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9) Dongkuk Techco Rubber Industries Sdn. Bhd. LTZ Class II 1999-05-17
K983216 CVS PERSONAL LUBRICANT San-Mar Laboratories, Inc. HIS Class II 1999-05-17
K990411 MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE Karl Storz Endoscopy HIH Class II 1999-05-11
K991249 FALCON IVF FOUR WELL PLATE Becton Dickinson Labware MQK Class II 1999-05-05
K991251 FALCON IVF ONE WELL DISH Becton Dickinson Labware MQK Class II 1999-05-05
K991253 FALCON IVF ROUND DISH Becton Dickinson Labware MQK Class II 1999-05-05
K983776 EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP Evenflo Co., Inc. HGX Class II 1999-04-26
K983588 SPERM WASHING MEDIUM, MODIFIED SPERM WASHING MEDIUM Irvine Scientific Sales Co., Inc. MQL Class II 1999-04-26
K983579 SYNTHETIC SERUM SUBSTITUTE (SSS) Irvine Scientific Sales Co., Inc. MQL Class II 1999-04-23
K990387 ENDOMETRIAL SAMPLER U.A. Medical Products, Inc. HHK Class II 1999-04-20
K990147 BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771 Richard Wolf Medical Instruments Corp. HIN Class II 1999-04-16
K990737 'ECURLINE UMBILICAL CORD CLAMP #3500 Precision Dynamics Corp. HFW Class II 1999-04-06
K990004 DCI ENDOSCOPE KARL STORZ Endoscopy-America, Inc. HET Class II 1999-04-02
K981955 MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS Ls Rubber Sdn Bhd LTZ Class II 1999-03-15
K983202 HARWILL MEDICAL CERVITULA CERVICAL SPATULA Harwill Medical (Pty) , Ltd. HHT Class II 1999-03-15
K980964 MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS Ls Rubber Sdn Bhd HIS Class II 1999-03-12
K982739 GYNEX ELECTRODES Gynex Corp. HGI Class II 1999-03-12
K982738 VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) Gynecare, Inc. HIH Class II 1999-03-01
K984306 `THE INSEMINATOR' (PROPOSED) Wallach Surgical Devices, Inc. MFD Class II 1999-03-01
K982380 SURE Pleasure Latex Products Sdn. Bhd. HIS Class II 1999-02-26
K983204 HARWILL MEDICAL U-KLIP UMBILICAL CLAMP Harwill Medical (Pty) , Ltd. HFW Class II 1999-02-26
K982867 HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000 Davol Inc., Sub. C. R. Bard, Inc. HIG Class II 1999-02-19
K990067 SHEER GLYDE DAMS Louise C. Myers MSC Class II 1999-02-19
K983586 HTF MEDIUM, MODIFIED HTF MEDIUM- HEPES, HTF POWDER (WITHOUT ANTIBIOTICS), MODIFIED HTG POWDER- HEPES (WITHOUT ANTIBODITI Irvine Scientific Sales Co., Inc. MQL Class II 1999-02-18
K983589 P-1 (PREIMPLANTATION STAGE ONE) MEDIUM Irvine Scientific Sales Co., Inc. MQL Class II 1999-02-18
K982276 BAHO AUTOCLAVABLE LAPAROSCOPE Microptix Int'L, LLC HET Class II 1999-02-18
K983580 BLASTOCYST MEDIUM Irvine Scientific Sales Co., Inc. MQL Class II 1999-02-18
K983584 HUMAN SERUM ALBUMIN (HSA) Irvine Scientific Sales Co., Inc. MQL Class II 1999-02-08
K983595 TRANSMYOMETRIAL EMBRYO TRANSFER SET Cook Ob/Gyn MQF Class II 1999-02-08
K983326 OMNIFLATOR 7640 MODEL 7-640-00 Northgate Technologies, Inc. HIF Class II 1999-02-05
K983596 INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING Cook Ob/Gyn MQH Class II 1999-02-05
K983925 ENDOPATH ULTRA VERESS NEEDLE Ethicon Endo-Surgery, Inc. HIF Class II 1999-02-03
K984488 SHEER THIN Twe Companies, Inc. HIS Class II 1999-02-01
K983901 KSEA HF-SNARE KARL STORZ Endoscopy-America, Inc. HIH Class II 1999-02-01
K983897 CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G Ri Mos. S.R.L. HEE Class II 1999-02-01
K983642 COOK MINI-INCUBATOR Cook Ob/Gyn MQG Class II 1999-02-01
K982771 GYRUS HYSTEROSCOPIC RESECTOSCOPE Gyrus Medical , Ltd. HIH Class II 1999-01-21
K983593 OVUM PICK-UP ASPIRATION NEEDLES Cook Ob/Gyn MQE Class II 1999-01-21
K982515 POWER-DRIVE, WISAP MODEL #7688PD/7688PD1 Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh HET Class II 1999-01-19
K984172 MODIFICATION OF PURESPERM Nidacon International AB MQL Class II 1999-01-14
K982518 AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608 Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh HET Class II 1999-01-14
K983889 HYS-SURGIFLATOR 150P W.O.M. World of Medicine GmbH HIG Class II 1999-01-14
K982630 MEDWORKS VISUALIZATION INSEMINATION CATHETER Medworks Corp. MFD Class II 1999-01-14
K983569 KSEA MONOPOLAR VAPORIZATION ELECTRODES KARL STORZ Endoscopy-America, Inc. HIH Class II 1999-01-08
K984211 MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303 Medscand AB HIB Class II 1998-12-23
K983716 VITALCARE DISPOSABLE VAGINAL SPECULUM Vitalcare Group, Inc. HIB Class II 1998-12-23
K983590 GIFT CATHETER SET/S Cook Ob/Gyn MQF Class II 1998-12-21
K983591 INTRATUBAL TRANSFER SETS Cook Ob/Gyn MQF Class II 1998-12-21
K983594 EMBRYO TRANSFER CATHETERS/SETS Cook Ob/Gyn MQF Class II 1998-12-21
K984218 OASIS Glimex Corp. HIS Class II 1998-12-17
K983587 HYSTEROSCOPIC GIFT CATHETER SETS Cook Ob/Gyn MQF Class II 1998-12-16
K983609 COOK TEST TUBE HEATER Cook Ob/Gyn MQG Class II 1998-12-16
K982651 COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER Corometrics Medical Systems, Inc. HEL Class II 1998-12-11
K983320 ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS Suretex Prophylactics (India) , Ltd. HIS Class II 1998-12-11
K983599 SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT Andwin Scientific HHT Class II 1998-12-11
K983045 AMIELLE Owen Mumford USA, Inc. KXP Class II 1998-11-25
K981277 PERIFORM Verimed Holdings, Inc. HIR Class II 1998-11-20
K983428 SAFETEX CERVICAL SCRAPER (PLASTIC) Andwin Scientific HHT Class II 1998-11-16
K982924 DUREX SENSIDOM LATEX CONDOM London Intl., LLC HIS Class II 1998-11-16
K983380 DUREX LUBRAGEL LATEX CONDOM London Intl., LLC HIS Class II 1998-11-16
K983181 CYTOPREP Cytoprep Inc. Est. HHI Class II 1998-11-16
K983478 ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON Organic Essentials HEB Class II 1998-11-09
K982673 JUST BETWEEN US, PERSONAL LUBRICANT & CONDOM Key West Fragrance & Cosmetic HIS Class II 1998-10-29
K983052 PERITRON PERINEOMETER MODEL 9300V OR 9300A Cardio Design Pty. , Ltd. HIR Class II 1998-10-19
K983381 VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS Paragon Trade Brands, Inc. HEB Class II 1998-10-19
K981958 LEISEGANG VIDEO COLPOSCOPE Netoptix Corp. HEX Class II 1998-10-19
K982428 CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT) Innervision, Inc. HET Class II 1998-10-09
K974248 WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM Air-Shields, Inc. HGM Class II 1998-10-07
K982659 MEDIVISION HYSTEROSCOPE Medivision Scope Service Center, Inc. HIH Class II 1998-10-07
K973447 OMNIFLATOR 6630(6-630-00) Northgate Technologies, Inc. HIF Class II 1998-09-30
K972675 CO2 GAS WARMING UNIT (6-800-00) Northgate Technologies, Inc. HIF Class II 1998-09-30
K981260 KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M Clinical Innovations, Inc. HDB Class II 1998-09-22
K982565 EASY TRANS TIP Carl Schuh KXO Class II 1998-09-22
K981334 LAPARO CO2-PNEU (AND WITH VIDEO MONITORING) Richard Wolf Medical Instruments Corp. HIF Class II 1998-09-10
K982149 SMITH & NEPHEW DYONICS MICROLAPAROSCOPE Smith & Nephew, Inc. HET Class II 1998-09-10
K980238 GYNEX EXTENDED REACH NEEDLE Gynex Corp. HEE Class II 1998-08-21
K980976 AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP Hollister, Inc. HDB Class II 1998-08-21
K982628 MEDWORKS INSEMINATION CATHETER Medworks Corp. MFD Class II 1998-08-21
K982112 THERMATREK IRIS-3 INFRARED IMAGING SYSTEM Thermatrek, Inc. LHQ Class I 1998-08-20
K981130 KSEA ENDO TIP SYSTEM KARL STORZ Endoscopy-America, Inc. HET Class II 1998-08-19
K982383 PLATEX GENTLE GLIDE, SILK GLIDE, SLIMFITS, SOFT COMFORT AND PORTABLES TAMPONS Playtex Products, Inc. HIL Class II 1998-08-19
K982327 INFRAMETRICS INFRACAM-MED Inframetrics, Inc. LHQ Class I 1998-08-18
K981953 VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS Paragon Trade Brands, Inc. HEB Class II 1998-08-18
K980174 DUREX COLORS AND SCENTS London Intl., LLC HIS Class II 1998-08-13
K982464 SCC-23 SAFETY CLAMP AND CUTTER Women First Healthcare, Inc. KNA Class II 1998-08-11
K974479 SILIMED VAGINAL STENT Silimed, LLC KXP Class II 1998-08-05
K980719 CALM Lms Medical Systems , Ltd. HGM Class II 1998-07-31
K981760 PLAYTEX SILK GLIDE ODOR ABSORBING FLUSHABLE CARDBOARD TAMPONS #13598 Playtime Products, Inc. HEB Class II 1998-07-22
K970712 LAPARO-TENSER L & T S.N.C. DI E. Lucini & C. HET Class II 1998-07-21
K980302 WORKING ELEMENTS, RESECTOSCOPE SHEATHS, ELECTRODES, OBTURATORS, ENDOSCOPES Richard Wolf Medical Instruments Corp. HIH Class II 1998-07-20
K981463 OMNITECH RESECTOSCOPE ROLLER ELECTRODE Omnitech Systems, Inc. KNF Class II 1998-07-17
K974730 SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC) Graphic Controls Corp. KXO Class II 1998-07-14
K981464 OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE Omnitech Systems, Inc. KNF Class II 1998-07-10
K974763 DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA Deroyal Industries, Inc. HET Class II 1998-07-10
K980212 MITYVAC Prism Technologies, Inc. HDB Class II 1998-07-09
K974801 SINGLE CHANNEL BALLOON CANNULA Conkin Surgical Instruments , Ltd. HDP Class II 1998-07-09
K981828 GALILEO DISPOSABLE HYSTEROSCOPES Netoptix Corp. HIH Class II 1998-07-07
K981800 SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606 Equal Diagnostics, Inc. HIH Class II 1998-07-06
K981859 SURGIFLATOR-20 ECU W.O.M. World of Medicine GmbH HIF Class II 1998-06-26

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