meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
36
Latest Decision
2011-12-21

Clearances · page 13 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K113075 EMBRYO VIEWER SOFTWARE Unisense Fertilitech A/S MQG Class II 2011-12-21
K112317 FM-9000 PLUS FETAL AND MATERNAL MONITOR Advanced Instrumentations, Inc. HGM Class II 2011-12-21
K102898 BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE Panpac Medical Corporation LKF Class II 2011-12-15
K110325 AQUA LUBE Mayer Laboratories, Inc. NUC Class II 2011-12-08
K113061 LARGE/EXTRA LAGRE CONDOM Karex Industries Sdn. Bhd. HIS Class II 2011-12-07
K111751 VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS ETHICON, Inc. HIN Class II 2011-12-02
K112134 TRUCLEAR OPERATIVE HYSTEROSCOPE Smith & Nephew, Inc. HIH Class II 2011-11-22
K110294 HIGH FLOW INSUFFLATION UNIT UHI-4 Olympus Medical Systems Corporation HIF Class II 2011-11-18
K111955 MEDLINE PNEUMOPERITONEUM NEEDLE Medline Industries, Inc. HIF Class II 2011-11-16
K112357 VESSEL GUARDIAN Lexion Medical, LLC HIF Class II 2011-11-10
K110612 FM20 Mediana Co., Ltd. HGM Class II 2011-11-08
K113036 U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS Kimberly-Clark Corporation HEB Class II 2011-11-02
K112911 FETAL DOPPLER Beijing Choice Electronic Technololgy Co., Ltd. KNG Class II 2011-10-27
K112529 TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER Advanced Instrumentations, Inc. KNG Class II 2011-10-27
K112842 AMS ELEVATE PC American Medical Systems, Inc. OTP Class III 2011-10-25
K110993 FEMCHEC PRESSURE MANAGEMET DEVICE Femasys, Inc. LKF Class II 2011-10-12
K112635 U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS Kimberly-Clark Corp. HEB Class II 2011-10-07
K110819 SINGHMED ROOLIP MANIPULATOR J.Singh Instruments HEW Class II 2011-10-05
K111614 CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE Ge Healthcare Integrated IT Solutions HGM Class II 2011-09-26
K111934 PD-100 SERIES ULTRASONIC POCKET DOPPLER Advanced Instrumentations, Inc. KNG Class II 2011-09-22
K112159 CMS-1000FM CENTRAL MONITORING SYSTEM Advanced Instrumentations, Inc. HGM Class II 2011-09-21
K112187 FM-1000 PLUS FETAL MONITOR Advanced Instrumentations, Inc. HGM Class II 2011-09-21
K110766 KOLPLUX SYSTEM Kolplast CI Ltda HIB Class II 2011-09-15
K103426 LITE PELVIC FLOOR REPAIR KITS Boston Scientific Corp OTP Class III 2011-09-14
K112386 EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM Coloplast Corp. OTP Class III 2011-09-08
K111059 GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) Gyrus Acmi, Inc. HIN Class II 2011-09-01
K103358 ROMA (HE4 EIA + ARCHITECT CA 125 II) Fujirebio Diagnostics,Inc. ONX Class II 2011-09-01
K112163 MONICA IF24 Monica Healthcare OSP Class II 2011-08-30
K111441 UNIMAX VERESS NEEDLE Unimax Medical Systems, Inc. HIF Class II 2011-08-19
K111083 PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50 Philips Medizinsysteme Boeblingen GmbH, Cardiac AN HGM Class II 2011-08-17
K111715 EMBRYOSCOPE Unisense Fertilitech A/S MQG Class II 2011-08-11
K102516 LUCINA MODEL MELODI Genadyne Biotechnologies, Inc. HGX Class II 2011-08-11
K103028 EEVATM PETRI DISH Auxogyn, Inc. MQK Class II 2011-08-11
K110852 DOLPHIN 3 FLUID MANAGEMENT SYSTEM Gyrus Acmi, Inc. HIG Class II 2011-07-19
K110556 MINI TELEMETRY SYSTEM Wipro GE Healthcare Private, Ltd. HGM Class II 2011-07-19
K102815 SURELIFT PROLAPSE SYSTEM Neomedic International OTP Class III 2011-07-07
K111118 AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE American Medical Systems OTP Class III 2011-07-01
K110630 F10 Mediana Co., Ltd. KNG Class II 2011-06-24
K110566 VIBERECT PENILE VIBRATORY STIMULATION DEVICE Reflexonic, LLC KXQ Class II 2011-06-24
K101641 AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301 Ag Digital Technology Corp. LHQ Class I 2011-06-16
K111093 BILLY BOY MALE LATEX CONDOM Mapa GmbH HIS Class II 2011-06-03
K110669 TAMPAX C PLASTIC TAMPONS, UNSCENTED The Procter & Gamble Co. HEB Class II 2011-06-02
K103692 SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 Surgiquest, Inc. HIF Class II 2011-05-25
K103545 BT-350 Bistos Co., Ltd. HGM Class II 2011-05-13
K101585 K-Y BRAND LONG LASTING VAGINAL MOISTURIZER Johnson & Johnson Consumer & Personal Products Wor NUC Class II 2011-05-10
K102141 COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) Cook Urological, Inc. KNA Class II 2011-05-06
K102263 HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0 Mckesson Information Solutions, LLC HGM Class II 2011-05-05
K110288 FEMVUE SALINE-AIR DEVICE Femasys, Inc. LKF Class II 2011-04-28
K102480 INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA Jieying Laboratory, Inc. MQH Class II 2011-04-19
K102847 DISPOSABLE ENDOMETRIAL SUCTION CURETTE Jiangsu Suyun Medical Materials Co., Ltd. HHK Class II 2011-04-14
K110147 ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE Sti Medical Systems, LLC HEX Class II 2011-04-08
K100767 TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM Church & Dwight Co., Inc. MOL Class II 2011-04-05
K110038 TRUCLEAR MORCELLATOR SYSTEM Smith & Nephew, Inc. HIH Class II 2011-03-30
K103389 TRUCLEAR INCISOR PLUS BLADE 2.9 Smith & Nephew, Inc. HIH Class II 2011-03-25
K102958 PHILIPS AVALON FETAL MONITOR Philips Medizin Systeme Boblingen GmbH HGM Class II 2011-03-18
K103172 CIV-OB (PLUS) Civnet Communication, Ltd. HGM Class II 2011-03-11
K110343 TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP Mayborn Baby and Child / Jackel International, Ltd. HGX Class II 2011-03-11
K101458 LINA XCISE MODEL MOR-1515 Lina Medical Aps HET Class II 2011-03-11
K092433 DYSIS Forth Photonics Hellas SA HEX Class II 2011-03-10
K091010 TROKAMED MORCELLATOR Trokamed GmbH HET Class II 2011-03-01
K103119 BILLY BOY MALE LATEX CONDOM Sheila Pickering PHD HIS Class II 2011-02-24
K101988 HEAL FORCE CO2 INCUBATOR Shanghai Lishen Scientific Equipment Co., Ltd. MQG Class II 2011-02-08
K110124 FETAL DOPPLER JPD-100S Shenzhen Jumper Medical Equipment Co., Ltd. KNG Class II 2011-02-04
K101801 MONICA AN24 Monica Healthcare OSP Class II 2011-02-03
K090145 SURECALL EMG LABOR MONITOR Reproductive Research Technologies, LP OSP Class II 2011-01-25
K092963 GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3 Genx Intl., Inc. MQL Class II 2011-01-14
DEN090011 HEM-AVERT PERIANAL STABILIZER Plexus Biomedical, Inc. OOA Class II 2011-01-13
K102140 FETAL MONITORS, MODELS F2 AND F3 Edan Instruments, Inc. HGM Class II 2011-01-13
K101535 BT-CATH Utah Medical Products, Inc. OQY Class II 2011-01-11
K092183 EMBRYOSCOPE AND EMBRYOSLIDE Unisense Fertilitech A/S MQG Class II 2011-01-11
K100358 CENTRAL MONITORING SYSTEM Edan Instruments, Inc. HGM Class II 2011-01-06
K102600 SIMPLYGO BREAST PUMP Evenflo Company, Inc. HGX Class II 2010-12-22
K090324 ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY Sti Medical Systems HEX Class II 2010-12-20
K101003 RAPIDVIT BLAST, RAPIDWARM BLAST Vitrolife Sweden AB MQL Class II 2010-12-10
K103311 U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS Kimberly Clark Corporation HEB Class II 2010-12-10
K100596 CRYOPETTE Mid-Atlantic Diagnostics, Inc. MQK Class II 2010-12-06
K100916 MEDICON MOGEN CLAMP Medicon EG HFX Class II 2010-12-06
K102445 ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS Rostam , Ltd. HEB Class II 2010-11-10
K100797 FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS Edan Instruments, Inc. HGM Class II 2010-11-10
K101538 HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) Philips Electronics UK Limited HGY Class I 2010-11-05
K102138 ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER Edan Instruments, Inc. MAA Class II 2010-10-28
K102686 MYOSURE ROD LENS SCOPE SEALS Interlace Medical, Inc. HIH Class II 2010-10-15
K092398 HSV STRAW Cryo Bio System MQK Class II 2010-10-06
K101606 MICROMED PD-8K INSULATION DEFECT DETECTOR Mcgan Technology, LLC HFG Class II 2010-10-01
K102136 VESSEL GUARDIAN Lexion Medical, LLC HIF Class II 2010-09-27
K101157 E-BASIC SINGLE BREAST PUMP Mapa GmbH HGX Class II 2010-09-17
K100367 MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229 Origio A/S MQL Class II 2010-08-27
K101098 REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUSABLE APPLICATOR) MODEL: 83035 Lil Drug Store Products, Inc. NUC Class II 2010-08-17
K101241 REPLENS LONG-LASTING VAGINAL MOISTURIZER (PRE-FILLED APPLICATOR) Lil Drug Store Products, Inc. NUC Class II 2010-08-17
K093145 SPECTRA SERIES BREAST PUMP Uzinmedicare Co. HGX Class II 2010-08-13
K101960 SONOTRAX SERIES ULTRASONIC POCKET DOPPLER Edan Instruments, Inc. HEP Class II 2010-08-10
K101141 SEILER COLPOSCOPE, MODELS 935, 955 AND 985 Seiler Precision Microscopes HEX Class II 2010-08-06
K092982 THE PANPAC SUCTION CURETTE Panpac Medical Corporation HHK Class II 2010-07-26
K100420 PHILIPS OBTRACEVUE MODEL SW REV. G.00 Philips Medizin Systeme Boeblingen GmbH HGM Class II 2010-07-26
K091939 THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 Thermedx, LLC HIG Class II 2010-07-23
K092981 PANPAC VAGINAL PESSARY Panpac Medical Corporation HHW Class II 2010-07-22
K093648 SIMPLISSE ELECTRIC BREASTFEEDING COMPANION Simplisse, Inc. HGX Class II 2010-07-14
K100595 ECLERIS MICROSTAR COLPOSCOPE Ecleris USA HEX Class II 2010-07-09
K092985 BELLECUP Librette, Inc. HHE Class II 2010-06-28
K101320 VASOVAPOR Lexion Medical, LLC HIF Class II 2010-06-24

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