meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
32
Latest Decision
2004-02-05

Clearances · page 18 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K030837 40 L HIGH FLOW INSUFFLATOR F108 W.O.M. World of Medicine AG HIF Class II 2004-02-05
K033991 MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET Pall Medical HIF Class II 2004-01-22
K033403 T.S. MEDICAL CIRCUMCISION CLAMP T.S. Medical HFX Class II 2004-01-22
K033903 MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, Cook Urological, Inc. MQH Class II 2004-01-16
K032124 DUREX PLAY LUBRICANT Ssl Americas, Inc. HIS Class II 2004-01-16
K033904 PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES) Cook Urological, Inc. MQH Class II 2004-01-16
K033462 EARLY CLEAVAGE MEDIUM (ECM) Irvine Scientific Sales Co., Inc. MQL Class II 2004-01-15
K032585 TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM Ron-Tech Medical , Ltd. HDC Class II 2004-01-09
K033636 AMS LARGE PORE POLYPROPYLENE MESH American Medical Systems, Inc. OTP Class III 2003-12-31
K033113 UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753 Richard Wolf Medical Instruments Corp. HIH Class II 2003-12-23
K033541 LONG LOVE CONDOM Unidus Corp. HIS Class II 2003-12-23
K033076 LIFESTYLES LIQUID PERSONAL LUBRICANT Ansell Healthcare, Inc. HIS Class II 2003-12-19
K032887 PHENOL RED STOCK SOLUTION Irvine Scientific Sales Co., Inc. MQL Class II 2003-12-19
K031436 MEDISCOPE Sometech Corporation HEX Class II 2003-12-19
K033084 WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER Portex , Ltd. MQF Class II 2003-12-19
K032909 THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM Thai Nippon Rubber Industry Co., Ltd. HIS Class II 2003-12-16
K032835 H/S CATHETER SET Catheter Research, Inc. LKF Class II 2003-12-11
K032208 MONA LISA ASPIRATION NEEDLE Fertility Technology Resources, Inc. MQE Class II 2003-12-09
K033156 OB1 OBSTETRICAL DOPPLER D. E. Hokanson, Inc. KNG Class II 2003-12-09
K031787 SMITH & NEPHEW IUR MORCELLATION SYSTEM Smith & Nephew, Inc. HIH Class II 2003-12-02
K031463 MARINA MEDICAL SILICONE PESSARY Marina Medical Instruments, Inc. HHW Class II 2003-11-18
K032636 PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED) Playtex Products, Inc. HEB Class II 2003-11-14
K031007 KWIKEZE MALE CONDOM APPLICATOR Condax, LLC HIS Class II 2003-11-14
K031369 MERCATOR HEALTHCARE MALE LATEX CONDOM Mercator Healthcare , Ltd. HIS Class II 2003-10-31
K033131 NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068 The First Years, Inc. HGX Class II 2003-10-30
K032471 TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM Titronics Research & Development Co. LHQ Class I 2003-10-10
K032772 MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM Hill-Rom Manufacturing, Inc. HGM Class II 2003-10-08
K031974 ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0 Asap Endoscopic Products GmbH HIH Class II 2003-09-29
K030691 FETAL SPIRAL ELECTRODE, MODEL FSE07000 Clinical Innovations, Inc. HGP Class II 2003-09-17
K032566 NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP The First Years, Inc. HGX Class II 2003-09-15
K030466 HANDYDOP Elcat, GmbH KNG Class II 2003-09-12
K032173 FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS First Quality Hygienic, Inc. HIL Class II 2003-09-03
K030441 SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT Cook Ob/Gyn MQL Class II 2003-08-29
K032526 BINDER CO2 INCUBATOR SERIE CB Binder GmbH MQG Class II 2003-08-29
K030525 CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES Mid-Atlantic Diagnostics, Inc. MQG Class II 2003-08-27
K030693 KENTEX DISPOSABLE VAGINAL SPECULUM Kentron Health Care, Inc. HIB Class II 2003-08-27
K031639 INTERMED ZOOM COLPOSCOPE Intermed Group, Inc. HEX Class II 2003-08-22
K032252 MODEL 120 SERIES MATERNAL/FETAL MONITOR Ge Medical Systems Information Technologies HGM Class II 2003-08-21
K030490 ISM1+, IMS2+, AND UTM+ Medicult A/S MQL Class II 2003-08-20
K032080 ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS Rostam , Ltd. HIL Class II 2003-08-14
K031616 IUR FLUID MANAGEMENT SYSTEM W.O.M. World of Medicine AG HIG Class II 2003-08-13
K032015 EMBRYON ULTRASOUND NEEDLE GUIDE Rocket Medical Plc MQE Class II 2003-08-08
K031504 ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX Koven Technology, Inc. KNG Class II 2003-07-18
K031067 FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS First Quality Hygienic, Inc. HEB Class II 2003-07-14
K031014 HI-FLO THERME PNEU 45, WISAP #7083, 7083V Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh HIF Class II 2003-06-27
K031486 BLASTFREEZE AND BLASTTHAW Medicult A/S MQL Class II 2003-06-27
K031622 WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS Portex , Ltd. MQE Class II 2003-06-26
K031228 SYNVITRO HYADASE Medicult A/S MQL Class II 2003-06-24
K023333 MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR Pleasure Latex Products Sdn. Bhd. HIS Class II 2003-06-23
K031015 EMBRYOGLUE Vitrolife Sweden AB MQL Class II 2003-06-23
K030935 BERKELEY V-10 VACUUM CURETTAGE SYSTEM Acmi Corporation HHI Class II 2003-06-23
K030761 KAISHOU VAGINAL SPECULUM Jiangsu Kaishou Medical Apparatus Co., Ltd. HIB Class II 2003-06-09
K031614 MEDELA PUMP IN STYLE ADVANCED BREAST PUMP Medela, Inc. HGX Class II 2003-06-06
K030469 LAPAROSHIELD CONDITIONED INSUFFLATION SET Pall Medical HIF Class II 2003-05-09
K031213 AQUASENS FLUID MONITORING SYSTEM Davol, Inc. HIG Class II 2003-04-30
K030261 BATTERY, RECHARGEABLE Access Battery, Inc. HGM Class II 2003-04-24
K030056 WORRY-REMOVER IRRIGATOR Corisen Group, Ltd. HED Class I 2003-04-22
K030176 LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING LUBRICANT Suretex, Ltd. HIS Class II 2003-04-17
K030165 THERMATREK IRIS-IV INFRARED IMAGING SYSTEM Thermatrek LHQ Class I 2003-04-16
K022449 HYSTEREOSCOPY PUMP HM4 W.O.M. World of Medicine AG HIG Class II 2003-04-10
K021237 COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS CooperSurgical, Inc. HET Class II 2003-04-10
K022614 INVIGRA Indus Medicare , Ltd. HIS Class II 2003-04-08
K030850 ENHANCE HUMAN SERUM ALBUMIN Conception Technologies MQL Class II 2003-04-08
K021876 MAS WITH OR WITHOUT SYRINGE Marina Medical Instruments, Inc. HHK Class II 2003-04-08
K030018 MHS 7000 Micro Health Systems, Inc. LHQ Class I 2003-03-26
K024324 LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9 Global Protection Corp. HIS Class II 2003-03-25
K030117 ENHANCE SPERM FREEZE Conception Technology, Inc. MQL Class II 2003-03-20
K023465 KENDRO HERACELL 240 INCUBATOR Kendro Laboratory Products, L.P. MQG Class II 2003-03-10
K023082 BABYCARE Bionet Company, Ltd. HEP Class II 2003-03-03
K024290 PROMOTOR FINAL RINSE SPERM WASH MEDIUM Ceres Fertility, Inc. MQL Class II 2003-03-03
K023931 PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A Philips Medical Systems, Inc. HGM Class II 2003-02-24
K024302 PRECISION CAPILLARIES FOR MICROMANIPULATION Brinkmann Instruments, Inc. MQH Class II 2003-02-19
K030116 ENHANCE-S PLUS H Conception Technology, Inc. MQL Class II 2003-02-12
K021193 FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 Fortune Medical Instrument Corp. HDB Class II 2003-02-12
K023925 MARK I THERMAL IMAGER Ix-Dr, Inc. LHQ Class I 2003-02-11
K021153 GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000 Goldway Us, Inc. HEX Class II 2003-02-10
DEN020001 BREASTVIEW VISUAL MAPPING SYSTEM Assurance Medical NKA Class II 2003-01-31
K022052 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 Northgate Technologies, Inc. HIF Class II 2003-01-24
K022445 VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V Olympus Optical Co., Ltd. HIH Class II 2003-01-24
K030078 BURBANK TENACULUM, MODEL 09-0011-01 Vascular Control Systems, Inc. HDC Class II 2003-01-24
K023930 COOPERSURGICAL OOCYTE RECOVERY NEEDLES CooperSurgical, Inc. MQE Class II 2003-01-22
K023618 SONICAID ONE Oxford Instruments Medical , Ltd. HGM Class II 2003-01-22
K023128 NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM Secure Scientific Sdn Bhd HIS Class II 2003-01-22
K023850 SYDNEY IVF EMBRYO BIOPSY MEDIUM Cook Ob/Gyn MQL Class II 2003-01-22
K021739 LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002 Limerick, Inc. HGX Class II 2003-01-10
K024197 LIFEDOP DOPPLER Summit Doppler Systems, Inc. KNG Class II 2003-01-03
K023222 ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-12 Invitrocare, Inc. MQL Class II 2002-12-26
K023305 KEGELMASTER 2000 Kegelmaster 2000 , Ltd. HIR Class II 2002-12-26
K023353 SYDNEY IVF HYALURONIDASE Cook Urological, Inc. MQL Class II 2002-12-20
K021115 GYNEFLEX Naissance Holdings, LC HIR Class II 2002-12-20
K023382 COOPERSURGICAL MALLEABLE SYTLET Cooper Surgical MQF Class II 2002-12-20
K023143 ECHO SOUNDER, ES-102EX Koven Technology, Inc. KNG Class II 2002-12-19
K022979 LAPARETTE, MODEL LAP J L S H N Instruments Medicaux G.B., Inc. KNF Class II 2002-12-18
K023405 TROJAN MINT TINGLE BRAND LATEX CONDOMS Armkel, LLC HIS Class II 2002-12-16
K023655 ENHANCE HTF MEDIUM WITH HEPES Conception Technologies MQL Class II 2002-12-13
K023383 COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER Cooper Surgical MQF Class II 2002-12-13
K023175 UNIDUS MALE LATEX CONDOM (WITH COLOR AND FLAVORING) Unidus Corp. HIS Class II 2002-12-13
K023717 SPERM WASH MEDIUM WITH GENTAMICIN Conception Technologies MQL Class II 2002-12-13
K023017 TUCKER EMBRYO CATHETER Fertility Technology Resources, Inc. MQF Class II 2002-12-13
K023384 COOPERSURGICAL TRIAL TRANSFER CATHETER Cooper Surgical MQF Class II 2002-12-13

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