meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
33
Latest Decision
2002-12-13

Clearances · page 19 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K023403 SPERMGRAD, MODELS 10022/10063 Vitrolife Sweden AB MQL Class II 2002-12-13
K023176 UNDUS MALE LATEX CONDOM (WITH FLAVORING) Unidus Corp. HIS Class II 2002-12-13
K023129 UNIDUS MALE LATEX CONDOM (YELLOW, PINK, GREEN & BLACK) Unidus Corp. HIS Class II 2002-12-13
K023051 INTRAUTERINE DELIVERY SYSTEM - INJECTOR Prosurg, Inc. LKF Class II 2002-12-12
K023059 UNIDUS MALE LATEX CONDOM Unidus Corp. HIS Class II 2002-12-12
K023379 COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER Cooper Surgical MQF Class II 2002-12-11
K023789 O.B. TAMPONS Mcneil-Ppc, Inc. HEB Class II 2002-12-06
K022933 EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT Evenflo Company, Inc. HGX Class II 2002-12-02
K023479 FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGES First Quality Hygienic, Inc. HEB Class II 2002-11-26
K022861 SAFETOUCH Rusin Medical Devices NHM Class II 2002-11-26
K023033 ALLGRAD WASH (HERPES BUFFERED WASHING MEDIUM) <Genx> Intl., Inc. MQL Class II 2002-11-26
K023434 DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM Dorex, Inc. LHQ Class I 2002-11-14
K023206 SPERM CRYOPROTEC Nidacon International AB MQL Class II 2002-11-08
K021247 PNEUMOPERITONEUM INSUFFLATION NEEDLE Mectra Labs, Inc. HIF Class II 2002-11-08
K022643 BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540 Swemed Lab International AB MQH Class II 2002-11-05
K023106 PROMOTOR Ceres Fertility, Inc. MQL Class II 2002-11-05
K022948 VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L Medical Action Industries, Inc. HIB Class II 2002-11-04
K022931 HYALURONIDASE SOLUTION Irvine Scientific Sales Co., Inc. MQL Class II 2002-11-04
K022593 THOMAS MEDICAL ELECTRODES Thomas Medical, Inc. HGI Class II 2002-11-01
K022594 PLAYTEX BREAST PUMP Playtex Products, Inc. HGX Class II 2002-11-01
K022503 UTERINE INJECTOR Thomas Medical, Inc. LKF Class II 2002-10-25
K021186 CONDOMI NATURE, CONDOMI STIMULATION, CONDOMI VANILLA GOLD, CONDOMI SUPERSAFE, CONDOMI XXL, CONDOMI STRONG, Condomi Erfert Prodoktionsgesellschaft Mbh HIS Class II 2002-10-25
K021854 DFV CPG COLPOSCOPE D.F. Vasconcellos S.A. HEX Class II 2002-10-25
K021125 SENSUA! Aac Consulting Group, Inc. HIS Class II 2002-10-25
K023227 USG 2000SA Ultraguide , Ltd. HHJ Class II 2002-10-22
K022384 XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP Isolux America HET Class II 2002-10-18
K022748 REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS Medical Device Services HET Class II 2002-10-09
K022140 WHISPER WEAR BREAST PUMP Whisper Wear HGX Class II 2002-09-30
K022318 VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES Vomed Volzer Medizintechnik GmbH & Co. HIF Class II 2002-09-19
K022882 MODIFICATION TO PLAYTEX TAMPONS #24002 Playtex Products, Inc. HIL Class II 2002-09-16
K022295 G-RINSE, MODEL 10031 Vitrolife Sweden AB MQL Class II 2002-09-12
K022247 G-SPERM, MODEL 10032 Vitrolife Sweden AB MQL Class II 2002-09-06
K021894 G-MM, MODEL 10038 Vitrolife Sweden AB MQL Class II 2002-09-06
K022245 G-FERT, MODEL 10033 Vitrolife Sweden AB MQL Class II 2002-09-06
K022244 G-1 VERSION 3, MODEL 10048 Vitrolife Sweden AB MQL Class II 2002-09-06
K021890 G-2 VERSION 3, MODEL 10049 Vitrolife Sweden AB MQL Class II 2002-09-06
K021896 HSA-SOLUTION, MODEL 10034/10064 Vitrolife Sweden AB MQL Class II 2002-09-06
K021893 G-MOPS, MODEL 10030 Vitrolife Sweden AB MQL Class II 2002-09-06
K021875 MALE LATEX CONDOM WITH DOTTED/RIBBED SURFACE AND COUNOUR-WALLED SHAPE (3 IN 1 ULTIMATE MALE LATEX CONDOM Pleasure Latex Products Sdn. Bhd. HIS Class II 2002-09-05
K022590 PVP (POLYVINYLPYRROLIDONE) <Genx> Intl., Inc. MQL Class II 2002-08-30
K022443 SPERMASSIST Nidacon International AB MQL Class II 2002-08-28
K022352 HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS) <Genx> Intl., Inc. MQL Class II 2002-08-28
K022334 HTF PLUS - HTF WITH NON-ESSENTIAL AMINO ACIDS <Genx> Intl., Inc. MQL Class II 2002-08-28
K022547 ACIDIFIED TYRODES SOLUTION <Genx> Intl., Inc. MQL Class II 2002-08-28
K021737 REPHRESH VAGINAL GEL Columbia Laboratories, Inc. NUC Class II 2002-08-26
K022330 ALLGRAD 45 AND 90 CELL SEPARATION MEDIA <Genx> Intl., Inc. MQL Class II 2002-08-26
K022332 LITE MINERAL OIL <Genx> Intl., Inc. MQL Class II 2002-08-23
K022335 ALLGRAD AND ALLGRAD100 <Genx> Intl., Inc. MQL Class II 2002-08-23
K022480 ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC Acmi Corporation HIH Class II 2002-08-22
K011327 DB1 EMBRYO FREEZE Zander Medical Supplies, Inc. MQG Class II 2002-08-15
K021574 TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER Card Guard Scientific Survival , Ltd. HGM Class II 2002-08-12
K022002 SYDNEY IVF CULTURE OIL Cook Urological, Inc. MQL Class II 2002-08-12
K021492 K-Y BRAND WARMING LIQUID PERSONAL LUBRICANT Personal Products Co., Div. of Mcneil Ppc, Inc. NUC Class II 2002-08-07
K021849 TAGG DISPOSABLE VAGINAL SPECULUM Tagg Industries HIB Class II 2002-07-16
K021438 INSEMINATION CATHETER, MODEL 320301 Labotect Labor-Technik Gottingen MFD Class II 2002-07-16
K021356 THE DIVACUP MENSTRUAL SOLUTION Diva International, Inc. HHE Class II 2002-07-16
K021676 CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL Cypress Medical Products, Ltd. HIB Class II 2002-07-12
K021224 ENDOCERVICAL BLOCK NEEDLE Wallach Surgical Devices, Inc. HEE Class II 2002-07-12
K021358 EMBRYO BIOPSY MEDIUM Irvine Scientific Sales Co., Inc. MQL Class II 2002-07-05
K021012 LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM Quality Medical Solusions, LLC HDY Class II 2002-06-25
K014166 UHI-3 HIGH FLOW INSUFFLATION UNIT Olympus Optical Co., Ltd. HIF Class II 2002-06-25
K021017 LEESPEC DISPOSABLE VAGINAL SPECULUM Itl Corporation Pty, Ltd. HIB Class II 2002-06-19
K020560 WORKBENCH BY <GENX> Genx Intl., Inc. MQG Class II 2002-06-19
K020959 GLO-SPEC I, II AND III Sol Weiss MD, Inc. HIB Class II 2002-06-19
K020827 K-Y BRAND ULTRA GEL PERSONAL LUBRICANT Personal Products Co., Div. of Mcneil Ppc, Inc. NUC Class II 2002-06-12
K012969 DOUBLE SPRINGERS NONOXNOL 9 CONDOM Medtech Products , Ltd. LTZ Class II 2002-06-12
K020783 TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB Telesis Technologies, Inc. LHQ Class I 2002-06-07
K020718 SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE Precision Dynamics Corp. HFW Class II 2002-06-03
K013258 INPATH E2 COLLECTOR Molecular Diagnostics HHT Class II 2002-05-31
K020628 CURELLE, PREFERRED CURELLE, CUTEQ 2.5 Bioteque America, Inc. HHK Class II 2002-05-24
K021272 SIB CATHETER, MODEL 61-7005 Ackrad Laboratories LKF Class II 2002-05-21
K020512 MTI ST#1 SILICONE PESSARY Medical Technology and Innovations, Inc. HHW Class II 2002-05-16
K020726 DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE Dukal Corp. HIB Class II 2002-05-15
K020633 NATURAL AND COLORED LATEX CONDOM WITH FLAVORS Ls Rubber Sdn Bhd HIS Class II 2002-05-15
K021042 THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS; MODELS # 7456, 7457, 7458,7459,7475,7476 Thermo Forma, Inc. MQG Class II 2002-05-15
K021135 MODEL 2120IS SERIES MATERNAL/FETAL MONITOR Ge Medical Systems Information Technologies HGM Class II 2002-05-09
K020535 INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS Rostam , Ltd. HEB Class II 2002-05-09
K020375 THE NURTURE III BREAST PUMP Bailey Medical Engineering HGX Class II 2002-05-03
K021055 BUSSE UMBILICAL CORD CLAMP CUTTER Busse Hospital Disposables, Inc. HFW Class II 2002-04-29
K020272 MALE LATEX CONDOM WITH RIBBED SURFACE Pleasure Latex Products Sdn. Bhd. HIS Class II 2002-04-26
K020954 H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY Ackrad Laboratories LKF Class II 2002-04-24
K020390 MODIFICATION TO FETAL ASSIST Huntleigh Diagnostics , Ltd. LQK Class II 2002-04-19
K013281 VERSALAB APM Nicolet Biomedical HGM Class II 2002-04-18
K013597 TAMPONADE UTERINE BALLOON CATHETER SET Cook Ob/Gyn KNA Class II 2002-04-17
K020292 UTERINE INJECTOR Catheter Research, Inc. LKF Class II 2002-04-17
K020951 H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 Ackrad Laboratories LKF Class II 2002-04-16
K020447 MITYVAC MERLIN, MODEL 10027 Prism Enterprises, Inc. HDB Class II 2002-04-12
K011510 MULTI HI-FLO PNEU, WISAP #7080 Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh HIF Class II 2002-04-02
K020659 DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT Ssl Americas, Inc. HIS Class II 2002-03-29
K020490 PBS, PBSW WITH CATIONS AND PHENOL RED Conception Technologies MQL Class II 2002-03-28
K011378 JOE LUB HELMET CONDOM Marketing Sales Concepts, Inc. (Msci) HIS Class II 2002-03-25
K011363 JOE LUBE CONDOM Marketing Sales Concepts, Inc. (Msci) HIS Class II 2002-03-25
K014248 DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER Urogyn , Ltd. KNA Class II 2002-03-21
K011688 PELVICFLEXER EXERCISE DEVICE Pelvicflex, Inc. HIR Class II 2002-03-20
K013612 INCARE PELVIC FLOOR THERAPY SYSTEM Hollister, Inc. HIR Class II 2002-03-19
K020200 PLAYTEX DEODORANT TAMPONS, MODEL 34802 Playtex Products, Inc. HIL Class II 2002-03-13
K020202 PLAYTEX DEODORANT TAMPONS, MODEL 34702 Playtex Products, Inc. HIL Class II 2002-03-12
K020201 PLAYTEX DEODORANT TAMPONS, MODEL 34902 Playtex Products, Inc. HIL Class II 2002-03-12
K012869 GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25 Gimmi GmbH HIH Class II 2002-03-11
K020518 MEDELA SYMPHONY BREAST PUMP, MODEL 024 Medela, Inc. HGX Class II 2002-03-07

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