meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
34
Latest Decision
2001-03-30

Clearances · page 21 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K010028 SHEER THIN AROMAS RED LATEX CONDOM Eagle Twe, Inc. HIS Class II 2001-03-30
K004051 SHEER THIN AROMAS YELLOW LATEX CONDOM Eagle Twe, Inc. HIS Class II 2001-03-29
K004016 SHEER THIN AROMAS BLUE LATEX CONDOM Eagle Twe, Inc. HIS Class II 2001-03-27
K004036 SHEER THIN AROMAS GREEN LATEX CONDOM Eagle Twe, Inc. HIS Class II 2001-03-27
K003156 BLASTASSIST SYSTEM Medicult A/S MQL Class II 2001-03-22
K003404 SUPRASPERM SYSTEM Medicult A/S MQL Class II 2001-03-22
K003163 SYNVITRO FLUSH Medicult A/S MQL Class II 2001-03-22
K002696 WHITTLESTONE BREASTPUMP Whittlestone, Inc. HGX Class II 2001-03-21
K010298 MN-4 COARSE MANIPULATOR Narishige Co., Ltd. MQJ Class II 2001-03-16
K010425 EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY) Hdc Corp. KNF Class II 2001-03-15
K010182 VCF PERSONAL LUBRICANT Apothecus Pharmaceutical Corp. NUC Class II 2001-03-09
K002150 SONICAID FM820, SONICAID FM830 Oxford Instruments HGM Class II 2001-03-09
K003867 EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET) Biofilm, Inc. NUC Class II 2001-03-09
K002548 FETAL ASSIST Huntleigh Diagnostics , Ltd. HGM Class II 2001-03-06
K010096 MULTI CARE THERAPEUTIC VIBRATOR Multicept A/S KXQ Class II 2001-03-05
K000180 TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP Richard Wolf Medical Instruments Corp. HIF Class II 2001-03-02
K003703 TAUT-INSUFFLATION NEEDLE Taut, Inc. HIF Class II 2001-02-22
K003792 STRYKER HEATED INSUFFLATOR TUBE SET Stryker Corp. HIF Class II 2001-02-21
K002912 VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073 Sterinc HIB Class II 2001-02-21
K003332 MEDITHERM MED2000 Meditherm, Inc. LHQ Class I 2001-02-21
K003608 SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY Aesculap, Inc. HGI Class II 2001-02-20
K003130 REGUTHERM 952 THERMOGRAPHIC SYSTEM Sie-Med, Inc. LHQ Class I 2001-02-16
K003540 (DISPOSABLE) VAGINAL SPECULUM Feminica, Inc. HIB Class II 2001-02-09
K003843 ENVIVE MINIFORMS Procter & Gamble Co. HHD Class I 2001-02-08
K002042 TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 New England Medical Corp. HGI Class II 2001-02-01
K010056 UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450 A & A Medical, Inc. LKF Class II 2001-02-01
K003380 BIOTEQUE VAGINAL DILATOR Bioteque America, Inc. HDX Class II 2001-01-29
K003375 CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX Tecnilatex S.A. LTZ Class II 2001-01-28
K003751 HYALURONIDASE REAGENT, MODEL CAT#2212 Invitrocare, Inc. MQL Class II 2001-01-17
K003278 COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922 Irvine Scientific Sales Co., Inc. MQL Class II 2001-01-17
K003164 TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM Richard Wolf Medical Instruments Corp. HET Class II 2001-01-08
K001576 EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY Prosurg, Inc. NBV Class II 2000-12-28
K002830 PELVIC MUSCLE THERAPY Colonial Medical Supply HIR Class II 2000-12-27
K003734 SERUM PROTEIN SUBSTITUTE Sage Biopharma MQL Class II 2000-12-21
K002393 NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM Innolatex Sdn. Bhd HIS Class II 2000-12-19
K002971 MTG - MINITUB HEATED STAGE SYSTEMS Zander Medical Supplies, Inc. MQG Class II 2000-12-15
K003056 OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218 Labotect Labor-Technik Gottingen MQE Class II 2000-12-13
K003448 DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301 Irvine Scientific Sales Co., Inc. MQL Class II 2000-12-07
K000806 KARL STORZ HYSTEROMAT II KARL STORZ Endoscopy-America, Inc. HIG Class II 2000-11-30
K002834 SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR Srs Medical Systems, Inc. HIR Class II 2000-11-29
K003142 MICROMANIPULATOR Research Instruments , Ltd. MQJ Class II 2000-11-22
K003304 IM-6 MICROINJECTOR Narishige Co., Ltd. MQJ Class II 2000-11-22
K001600 <GENX> CODA INCUBATOR CELLMATE <Genx> Intl., Inc. MQG Class II 2000-11-22
K003302 IM-5A INJECTOR Narishige Co., Ltd. MQJ Class II 2000-11-22
K003303 IM-5B MICROINJECTOR Narishige Co., Ltd. MQJ Class II 2000-11-22
K003300 MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR Narishige Co., Ltd. MQJ Class II 2000-11-22
K002630 PURESPERM WASH Nidacon International AB MQL Class II 2000-11-21
K003298 MO-202U THREE-AXIS JOYSTICK HYDRAULIC MICROMANIPULATOR Narishige Co., Ltd. MQJ Class II 2000-11-21
K002961 MINITUB MULTI-PURPOSE CASSETTES Zander Medical Supplies, Inc. MQG Class II 2000-11-21
K002623 PURESPERM 40 AND PURESPERM 80 Nidacon International AB MQL Class II 2000-11-20
K003184 RS BIOTECH GALAXY 'R' CO2 INCUBATOR Zander Medical Supplies, Inc. MQG Class II 2000-11-20
K002595 CBS STRAW Cryo Bio System MQG Class II 2000-11-17
K002571 MULITPLE MALE LATX CONDOM Pleasure Latex Products Sdn. Bhd. HIS Class II 2000-11-16
K002520 ROVERS SPATULA Rovers Medical Devices B.V. HHT Class II 2000-11-13
K002503 FETALGARD LITE Analogic Corp. HGM Class II 2000-11-09
K002805 KENDRO HERACELL CO2 INCUBATOR Kendro Laboratory Products, L.P. MQG Class II 2000-11-09
K992493 VIPON TAMPON Another Way Products, LLC HEB Class II 2000-11-06
K000620 PBN FALLOPIAN TUBE CATHETER SYSTEM Medical Device Technologies, Inc. MDG Class II 2000-10-30
K002850 MWO-202 3D HYDRAULIC COARSE/FINE MICROMANIPULATOR Narishige Co., Ltd. MQJ Class II 2000-10-05
K002836 MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE Sage Biopharma MQL Class II 2000-10-03
K994008 BIOSYS FETAL MONITOR, MODEL IFM-500 Biosys Co. , Ltd. HGM Class II 2000-09-29
K002653 MMN-1 COARSE MANIPULATOR Narishige Co., Ltd. MQJ Class II 2000-09-22
K002659 MMO-202ND THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANPULATOR Narishige Co., Ltd. MQJ Class II 2000-09-22
K002658 MMO-202N THREE-AXIS JOYSTICK OIL HYDRAULIC MICROMANIPULATOR Narishige Co., Ltd. MQJ Class II 2000-09-22
K001882 BABY DOPPLEX 4002-TWINS, MODEL BD4002 Huntleigh Healthcare, Inc. HGM Class II 2000-09-19
K002329 PELVX GELLHORN VAGINAL PESSARY 603-608 Deschutes Medical Products, Inc. HHW Class II 2000-09-18
K002385 COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM, Cook Ob/Gyn MQL Class II 2000-09-18
K001486 GENX CODA AIR PURIFICATION SYSTEM <Genx> Intl., Inc. MQG Class II 2000-09-15
K002383 COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT Cook Ob/Gyn MQL Class II 2000-09-13
K002293 3D MOTOR-DRIVEN COARSE MANIPULATOR MM-188NE Narishige Co., Ltd. MQJ Class II 2000-09-13
K002291 MOTOR-DRIVE MANIPULATOR MM-89 Narishige Co., Ltd. MQJ Class II 2000-09-13
K002096 TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR; TAMPAX TAMPONS, OPEN END FLUSHABLE APPLICATOR Procter & Gamble Co. HEB Class II 2000-09-08
K002060 NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL Dongkuk Techco Rubber Industries HIS Class II 2000-09-07
K001818 UTERINE TENACLUM HOOK Towne Brothers (Pvt.), Ltd. HDC Class II 2000-08-30
K001740 KSEA MONOPOLAR VAPORIZATION ELECTRODES KARL STORZ Endoscopy-America, Inc. HIH Class II 2000-08-22
K993403 REMED MALE TUTTI FRUTTI CONDOM (STRAWBERRY) PREVENTOR, LUCKY BOY, SUMMIT Remed Pharma HIS Class II 2000-08-18
K993409 REMED MALE TUTTI FRUTTI CONDOM (COCONUT) PREVENTOR, LUCKY BOY, SUMMIT Remed Pharma HIS Class II 2000-08-18
K001615 HUNTER SCIENTIFIC INJECTION PIPETTES Hunter Scientific Limited MQH Class II 2000-08-18
K993389 REMED MALE TUTTI FRUTTI CONDOM (BANANA), PREVENTOR, LUCKY BOY, SUMMIT Remed Pharma HIS Class II 2000-08-18
K994118 OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS Guilin Latex Factory HIS Class II 2000-08-14
K001967 PVP-POLYVINYLPYRROLIDONE REAGENT, MODEL CAT#2210 Invitrocare, Inc. MQL Class II 2000-08-14
K001677 BABY DOPPLEX 4000 (BD4000) Huntleigh Diagnostics , Ltd. HGM Class II 2000-08-14
K000736 LA JOIE Goomi Ehwa, Inc. HED Class I 2000-08-08
K001978 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 Thai Nippon Rubber Industry Co., Ltd. LTZ Class II 2000-08-08
K001641 TAMPONS Rostam , Ltd. HEB Class II 2000-08-03
K001077 LUBRIGEL PERSONAL LUBRICANT Sheffield Laboratories, Div. of Faria Limited, LLC NUC Class II 2000-08-02
K001555 SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 Sims Portex , Ltd. HHK Class II 2000-08-02
K993140 WATER FOR TISSUE CULTURE, MODELS 1500 Conception Technologies MTW Class II 2000-08-02
K001590 DND 101 Urogyn , Ltd. KNA Class II 2000-08-02
K001883 LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM Ansell Healthcare, Inc. HIS Class II 2000-07-31
K001533 SURGIFLATOR-40 W.O.M. Gmhb HIF Class II 2000-07-31
K001314 MEDSCOPE All-Pro Imaging Corp. HEX Class II 2000-07-25
K991279 MEDI-CULT UNIVERSAL IVF-MEDIUM Medicult A/S MQL Class II 2000-07-20
K001524 FORMA SCIENTIFIC DIRECT HEAT INCUBATORS Thermoquest Corp. MQG Class II 2000-07-12
K001911 IM-9A MICROINJECTORS Narishige Co., Ltd. MQJ Class II 2000-07-07
K001910 IM-9C MICROINJECTORS Narishige Co., Ltd. MQJ Class II 2000-07-07
K001912 IM-9B MICROINJECTORS Narishige Co., Ltd. MQJ Class II 2000-07-07
K993527 LOOP ELECTRODE, BALL ELECTRODE Palm Medical USA, Inc. HGI Class II 2000-07-06
K000619 SCANDINAVIAN IVF SCIENCES AB, G2.2 Vitrolife AB/Scandinavian Ivf Sciences AB MQL Class II 2000-06-27
K000707 LEICA COLPOSCOPE Leica Microscopy Systems , Ltd. HEX Class II 2000-06-27

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