meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
42
Latest Decision
2002-03-05

Clearances · page 20 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K013433 TROJAN PASSION BERRY GEL Armkel, LLC NUC Class II 2002-03-05
K013653 INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE Hollister, Inc. HIR Class II 2002-03-05
K020223 INVIGRA Indus Medicare , Ltd. HIS Class II 2002-03-04
K012535 DRG DISPOSABLE VAGINAL SPECULUM Doctor'S Research Group, Inc. HIB Class II 2002-03-01
K014300 SAFETOUCH James D Rusin MD, MBA NHM Class II 2002-03-01
K011488 SPIRABRUSH CX BIOPSY INSTRUMENT Trylon Corp. HFB Class I 2002-02-22
K013547 BABYCOM Pmg Medica , Ltd. KNG Class II 2002-02-20
K020143 VASOVIEW 5 HARVESTING CANNULA Guidant Corporation, Cardiac Surgery HET Class II 2002-02-20
K012003 DRG REACTION CHAMBER/SAFETY TIP Doctor'S Research Group, Inc. HEI Class II 2002-02-12
K012811 BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B Humagen Fertility Diagnostics, Inc. MQH Class II 2002-02-11
K012277 PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE Sims Portex , Ltd. HHW Class II 2002-02-11
K013747 TEKNO-MEDICAL OBSTETRICAL FORCEPS Tekno Medical Optik-Chirurgie GmbH & Co. HDA Class II 2002-02-11
K014160 PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES) Cook Urological, Inc. MQG Class II 2002-02-08
K013614 TROJAN CRYSTAL CLEAR LIQUID Armkel, LLC NUC Class II 2002-02-01
K013773 SAFE Ssn Medical Products Sdn. Bhd. HIS Class II 2002-01-24
K013518 EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM Irvine Scientific Sales Co., Inc. MQL Class II 2002-01-18
K013460 SWIFT LOW PROFILE CUP (PRO CUP) Swift Delivery Products HDB Class II 2002-01-17
K013870 SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208; SMITH & NEPHEW CONTINUOUS FLOW SHEATH, MODEL 8105224 Smith & Nephew, Inc. HIH Class II 2002-01-17
K013835 GLOBAL HEALTHCARE VAGINAL SPECULUM Dynascend Consulting Int'L, LLC HIB Class II 2002-01-17
K013477 TOCO LITE, MODEL TD-01 Ventrex, Inc. HFM Class II 2002-01-17
K014094 MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM Hill-Rom Manufacturing, Inc. HGM Class II 2002-01-11
K011876 DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 Circon Video HIG Class II 2002-01-08
K012275 PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP Limerick, Inc. HGX Class II 2002-01-07
K013289 BIOTEQUE VAGINAL PESSARIES Bioteque America, Inc. HHW Class II 2001-12-27
K013817 GLO-SPEC Sol Weiss MD, Inc. HIB Class II 2001-12-21
K013226 EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT Evenflo Company, Inc. HGY Class I 2001-12-20
K013972 H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005 Ackard Laboratories LKF Class II 2001-12-17
K013703 SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M Sanyo North America Corp. MQG Class II 2001-12-14
K013401 K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01 K-Systems, Kivex Biotec , Ltd. MQG Class II 2001-12-14
K013086 WET LIGHT PERSONAL MOISTURIZER Trigg Laboratories, Inc. HIS Class II 2001-12-13
K013536 EMTRAC; DELPHIN; SEMTRAC 2000 SET Gynetics Medical Products NV MQF Class II 2001-11-30
K013501 IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B Gynetics Medical Products NV MQF Class II 2001-11-30
K012917 DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B Dynarex Corp. HFW Class II 2001-11-28
K012070 ORALLITE COMPREHENSIVE EXAM TRAY Trylon Corp. MPU Class II 2001-11-27
K013437 SF SH CATHETER, MODEL R65-945 A & A Medical, Inc. LKF Class II 2001-11-19
K013491 HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948 A & A Medical, Inc. LKF Class II 2001-11-19
K012718 MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM. Ge Medical Systems Information Technologies HGM Class II 2001-11-13
K012962 DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM Innolatex Sdn. Bhd HIS Class II 2001-11-09
K012665 ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT Innolatex Sdn. Bhd HIS Class II 2001-11-09
K012664 ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT Innolatex Sdn. Bhd HIS Class II 2001-11-09
K013497 FAS SET #4551 Gynetics Medical Products NV MQE Class II 2001-11-09
K012964 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM Innolatex Sdn. Bhd HIS Class II 2001-11-09
K012859 NU-SPEC D Sol Weiss MD, Inc. HIB Class II 2001-10-26
K001974 EZ-ON CONDOM Mayer Laboratories MOL Class II 2001-10-24
K010053 HUMI-FLOW, MODEL 6-850-00/ 01/02 Northgate Technologies, Inc. HIF Class II 2001-10-23
K012935 THECURVE, ITEM 507 Select Medical Systems, Inc. MFD Class II 2001-10-11
K012629 ALWAYS DUETS Procter & Gamble Co. HHD Class I 2001-10-05
K012653 MALE LATEX CONDOM Qingdao Shuang Die Latex Production Co.,Ltd HIS Class II 2001-09-21
K011996 TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS Procter & Gamble Co. HIL Class II 2001-09-19
K011981 MHS 5000 Micro Health Systems, Inc. LHQ Class I 2001-09-05
K002328 SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM, SIOS-INTERFACE FOR LAPARO CO2 INSUFFLATOR Richard Wolf Medical Instruments Corp. HIF Class II 2001-08-27
K012220 TAO EMBRYO TRANSFER CATHETER SYSTEM Ttj Biomedical, LLC MQF Class II 2001-08-27
K012203 CLAY-PARK LABS, INC. - LUBRICATING JELLY Clay-Park Labs, Inc. NUC Class II 2001-08-27
K011069 AQUASENS FLUID MONITORING SYSTEM Davol Inc., Sub. C. R. Bard, Inc. HIG Class II 2001-08-16
K011519 AMEDA HYGIENIKIT Hollister, Inc. HGY Class I 2001-08-15
K011607 SPERMCATCH Nidacon International AB MQL Class II 2001-08-10
K011840 CERVILENZ UTERINE MEASURING SOUND Cervilenz, Inc. HHM Class I 2001-08-10
K011621 KOALA CLAMP, KOALA CLAMP AND CUTTER Maternus, Inc. HFW Class II 2001-08-10
K012123 NIDOIL Nidacon International AB MQL Class II 2001-08-03
K012068 WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S Sims Portex , Ltd. MQE Class II 2001-08-03
K011532 MITYVAC Prism Enterprises, Inc. HDB Class II 2001-07-30
K003805 GYNECOLOGICAL LAPAROSCOPES Global Endoscopy, Inc. HET Class II 2001-07-22
K003802 HYSTEROSCOPES Global Endoscopy, Inc. HIH Class II 2001-07-22
K011253 FLAVORED MALE LATEX CONDOM Thai Nippon Rubber Industry Co., Ltd. HIS Class II 2001-07-20
K011938 OIL FOR EMBRYO CULTURE Irvine Scientific Sales Co., Inc. MQL Class II 2001-07-18
K011606 PURESPERM BUFFER Nidacon International AB MQL Class II 2001-07-12
K003876 US SENSOR #CG-930P; TOCO SENSOR CG-940P Card Guard Scientific Survival , Ltd. HEL Class II 2001-07-09
K011512 MMODIFICATION TO LAMINARIA A & A Medical, Inc. HDY Class II 2001-07-09
K011573 HYALURONIDASE IN HTF MEDIUM; HYALURONIDASE IN EBSS MEDIUM Conception Technologies MQL Class II 2001-07-02
K011171 TAMPAX SCENTED & SATIN SCENTED TAMPAX-JUNIOR, REGULAR, SUPER & SUPER PLUS Procter & Gamble Co. HIL Class II 2001-07-02
K011481 10% PVP; 10% PVP IN EBSS SOLUTION Conception Technologies MQL Class II 2001-07-02
K011346 READYSWIM Nidacon International AB MQL Class II 2001-06-28
K010920 TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING Medical Cables, Inc. HEL Class II 2001-06-22
K010919 MALE NATURAL RUBBER LATEX CONDOM Innolatex Sdn. Bhd HIS Class II 2001-06-15
K011462 OIL FOR TISSUE CULTURE Conception Technologies MQL Class II 2001-06-13
K010986 LUNAPADS Lunapads International Products, Ltd. NUQ Class I 2001-06-13
K011598 WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE Irvine Scientific Sales Co., Inc. MTW Class II 2001-06-13
K011420 MM-87 MOTOR-DRIVE MANIPULATOR Narishige Co., Ltd. MQJ Class II 2001-06-12
K010752 AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY Aesculap, Inc. KNF Class II 2001-06-11
K011304 OB-1 FETAL MONITOR Analogic Corp. HGM Class II 2001-05-29
K011480 VIVA Richter Rubber Technology Sdn. Bhd. HIS Class II 2001-05-24
K002043 PELVEX HOMETRAINER Purdue Technology Park HIR Class II 2001-05-21
K010510 BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1 A & A Medical, Inc. HET Class II 2001-05-16
K010552 CG-900P FETAL/MATERNAL MONITOR Card Guard Scientific Survival , Ltd. HGM Class II 2001-05-11
K003405 ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO Highland / Marietta, Inc. KNF Class II 2001-05-07
K003458 SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 Clinical Innovations, Inc. HGP Class II 2001-05-03
K010695 KOALA CLAMP Maternus, Inc. HFW Class II 2001-05-03
K011157 COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT Cook Urological, Inc. MQL Class II 2001-05-03
K010867 KILEJIAN CIRCUMCISOR Iris Surgical, LLC HFX Class II 2001-05-03
K010183 GLOBAL BY <GENX> BLASTOCYST MEDIA <Genx> Intl., Inc. MQL Class II 2001-05-02
K010835 POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385 Busse Hospital Disposables, Inc. HFW Class II 2001-04-30
K992607 SONICAID SYSTEM 8002 Oxford Instruments Medical Systems HGM Class II 2001-04-27
K010178 SPERMICIDAL LUBRICATED MALE LATEX CONDOM Innolatex Sdn. Bhd LTZ Class II 2001-04-27
K010371 LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT Suretex, Ltd. HIS Class II 2001-04-27
K010889 BABY DOPPLEX 3000 MK 2 (BD3000) Huntleigh Healthcare, Inc. HGM Class II 2001-04-25
K010894 BABY DOPPLEX 3002 (BD3002) Huntleigh Healthcare, Inc. HGM Class II 2001-04-25
K010296 UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450 Marina Medical Instruments, Inc. LKF Class II 2001-04-11
K010199 PJUR EROS WATER FORMULATION L.C.C. Pjur Group Germany NUC Class II 2001-04-05
K002617 PERIFORM PERINEOMETRIC PROBE, MODEL 8300 Neen Design , Ltd. HIR Class II 2001-04-05
K003417 MINI FIBER ENDOSCOPES; OUTER SHEATHS; VERESS CANNULAS; VERESS CANNULAS WITH OUTER SHEATHS, SET Richard Wolf Medical Instruments Corp. HET Class II 2001-04-04

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