meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
37
Latest Decision
2005-08-19

Clearances · page 17 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K051273 DIVAS DUAL PLEASURE MALE LATEX CONDOM Eagle Twe, Inc. HIS Class II 2005-08-19
K043075 TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING Tenacore Holdings, Inc. HGM Class II 2005-08-18
K040428 MULTIPLE EROZONE BODYGLIDE FLUID, EROZONE BODYGLIDE GEL, EROZONE LATEX DRESSING, EROZONE BODYGLIDE NATURAL FOAM R & K International Cosmetics NUC Class II 2005-08-09
K051503 UGYTEX SUAL KNIT MESH Sofradim Production OTP Class III 2005-08-05
K051446 FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS First Quality Hygienic, Inc. HIL Class II 2005-07-14
K050887 GONGDONG DISPOSABLE VAGINAL SPECULUM Zhejiang Gongdong Medical Plastic Factory HIB Class II 2005-07-11
K051668 THE ART OF INTIMACY RESPONSE PERSONAL LUBRICANT Goodmark USA, Inc. NUC Class II 2005-07-08
K050583 MODEL 250 SERIES MATERNAL/FETAL MONITOR Ge Medical Systems Information Technologies HGM Class II 2005-06-21
K043480 ENHANCE CLITORAL STIMULATION AID Gynavations, Inc. NBV Class II 2005-06-08
K050660 FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS First Quality Hygienic, Inc. HEB Class II 2005-05-12
K050521 EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S Inntec, Inc. MQF Class II 2005-05-02
K050768 ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4 Hamilton Thorne Biosciences MRX Class II 2005-04-28
K050404 INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS Intuitive Surgical, Inc. HET Class II 2005-04-21
K041579 MEDELA SINGLE USE SILC CUP, MODEL 077.0791 Medela AG HDB Class II 2005-04-21
K042495 CUMULASE Halozyme Therapeutics, Inc. MQL Class II 2005-04-14
K043614 VACULINK, MODEL VCL 3000 Medevco, Inc. HDB Class II 2005-04-14
K042958 DUREX PLAY TINGLING LUBRICANT Ssl Americas, Inc. NUC Class II 2005-04-08
K050244 MALE NATURAL RUBBER LATEX CONDOM Nrs Global Partners HIS Class II 2005-04-08
K042470 DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOM Ssl Americas, Inc. HIS Class II 2005-04-05
K043533 SURGICAL DESIGN CIRCUMCISION CLAMP Surgical Design, Inc. HFX Class II 2005-04-01
K040335 MOONCUP, STYLE A & B Mooncup, LLC HHE Class II 2005-03-30
K050211 PERSONAL WARMING GEL Qualis, Inc. NUC Class II 2005-03-17
K050212 PERSONAL WARMING JELLY Qualis, Inc. NUC Class II 2005-03-17
K050355 PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150 Tissue Science Laboratories, Plc PAI Class III 2005-03-09
K043013 MILTEX LAPAROSCOPIC INSTRUMENTS Miltex, Inc. HET Class II 2005-03-04
K050360 TULIP CONDOM Shanghai Latex Factory HIS Class II 2005-03-01
K042957 DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT Ssl Americas HIS Class II 2005-02-17
K040788 CALM PATTERNS, VERSION 01.00.00 Lms Medical Systems , Ltd. HGM Class II 2005-02-08
K043369 CERVEX-BRUSH COMBI Rovers Medical Devices B.V. HHT Class II 2005-02-02
K050067 FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS First Quality Hygienic, Inc. HIL Class II 2005-02-01
K042082 AIRSTRIP OB Mp4 Solutions, LP HGM Class II 2005-01-21
K040625 ATAD ARD CATHETER Atad Developments , Ltd. HDY Class II 2005-01-18
K043116 ICSI-100 Vitrolife Sweden AB MQL Class II 2005-01-13
K041667 SAN-MAR LABS LUBRICATING JELLY San-Mar Laboratories, Inc. HIS Class II 2005-01-13
K041717 POWERSTICK MALE LATEX CONDOMS A.P.Deauville, LLC HIS Class II 2005-01-13
K041757 FEMSPEC DISPOSABLE VAGINAL SPECULUM Femspec LLC HIB Class II 2004-12-23
K042603 GYNECARE PROLENE FASTENER SYSTEM ETHICON, Inc. PBQ Class II 2004-12-22
K043098 GERBER DOUBLE ELECTRIC BREAST PUMP Gerber Products Co. HGX Class II 2004-12-15
K042950 VAG O SPECULUM, MODELS VS1, VM1, VL1 Panatrex, Inc. HIB Class II 2004-11-30
K041432 ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT Biofilm, Inc. HIS Class II 2004-11-30
K042773 ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS Rostam , Ltd. HIL Class II 2004-11-23
K041470 MORTON IUI CATHETERS Fertility Technology Resources, Inc. MQF Class II 2004-11-22
K041284 MEDICULT IVM SYSTEM Medicult A/S MQL Class II 2004-11-22
K042527 SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 Medical Action Industries, Inc. HHT Class II 2004-11-08
DEN040009 HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK) Hamilton Thorne Biosciences MRX Class II 2004-11-04
K041018 DRG SOFTRELEASE Doctor'S Research Group, Inc. HHT Class II 2004-10-18
K041774 IUR RECIPROCATING MORCELLATOR MODEL # 7210517 Smith & Nephew, Inc. HIH Class II 2004-10-07
K040189 ENDOMETRIAL SAMPLING SYRINGE Rocket Medical Plc HHK Class II 2004-10-04
K041062 INTRAUTERINE VENOGRAM NEEDLE SET Cook Urological, Inc. LKF Class II 2004-10-01
K041435 THE STRIPPER PGD Mid-Atlantic Diagnostics, Inc. MQH Class II 2004-09-29
K041560 FLO-ASSISTANT Northgate Technologies, Inc. HIF Class II 2004-09-28
K041129 PERSONAL LUBRICATING GEL Qualis, Inc. NUC Class II 2004-09-24
K041837 INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED Innolatex Sdn. Bhd HIS Class II 2004-09-24
K040392 TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING American I.V. Products, Inc. HFM Class II 2004-09-14
K041237 ECHOSAMPLER Gynetics Medical Products NV HFF Class II 2004-09-08
K040903 CADENCE, MODELS 2001 AND 2002 Edan Instruments, Inc. HGM Class II 2004-09-02
K040819 TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834 American I.V. Products, Inc. HGM Class II 2004-08-16
K040717 NUNC IVF MULTIDISH 4 WELLS NUNCLON Nunc A/S MQK Class II 2004-08-12
K041562 CRYOTIP Irvine Scientific Sales Co., Inc. MQH Class II 2004-08-09
K033614 MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215 Northgate Technologies, Inc. HIF Class II 2004-07-29
K040999 TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCIES) Procter & Gamble Co. HEB Class II 2004-07-09
K041321 VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM Richard Wolf Medical Instruments Corp. HET Class II 2004-07-09
K040530 MEDIA CULTURE SYSTEM <Genx> Intl., Inc. MQL Class II 2004-06-25
K033776 INSTEAD INTIMATE LUBRICANT Instead, Inc. NUC Class II 2004-06-25
K041332 JOEY CLAMP OPENING TOOL Maternus, Inc. HFW Class II 2004-06-25
K040817 POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM Advanced Urological Developments HIB Class II 2004-06-22
K040238 SOFTSEAL HSG CATHETER Modern Medical Equipment Mfg., Ltd. LKF Class II 2004-06-22
K041094 HSG CATHETER SET Bioteque America, Inc. LKF Class II 2004-06-17
K032644 KOLPEXIN SPHERE Adamed , Ltd. HHW Class II 2004-05-28
K030474 PH BUFFERING PLASTIC APPLICATOR TAMPON Rostam , Ltd. HEB Class II 2004-05-28
K040480 SONOTRAX ULTRASONIC POCKET DOPPLER Edan Instruments, Inc. KNG Class II 2004-05-25
K040623 AMS PERIGEE SYSTEM American Medical Systems, Inc. OTP Class III 2004-05-17
K040390 STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM Stryker Endoscopy HIH Class II 2004-05-17
K032877 G-OOCYTE Vitrolife Sweden AB MQL Class II 2004-05-07
K032154 G-FREEZEKIT BLAST Vitrolife AB MQL Class II 2004-05-07
K032155 G-THAWKIT BLAST Vitrolife AB MQL Class II 2004-05-07
K033101 G-PGD Vitrolife Sweden AB MQL Class II 2004-05-07
K040312 TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS Procter & Gamble Co. HIL Class II 2004-05-03
K040340 K-Y BRAND WARMING ULTRAGEL PERSONAL LUBRICANT Personal Products Company, Div. of Mcneil-Ppc, Inc. NUC Class II 2004-04-28
K033163 CAUTION CONDOMS Richard Van Haussen America, Inc. LTZ Class II 2004-04-27
K040185 DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOM Ssl Americas HIS Class II 2004-04-27
K034063 MULTIBLAST MEDIUM Irvine Scientific Sales Co., Inc. MQL Class II 2004-04-26
K040537 AMS APOGEE VAULT SUSPENSION SYSTEM American Medical Systems, Inc. OTP Class III 2004-04-22
K040085 PERSONAL WARMING LUBRICANT Qualis, Inc. HIS Class II 2004-04-20
K040052 FINE SURGICAL CIRCUMCISION CLAMP Fine Surgical Instrument Corp. HFX Class II 2004-04-09
K032845 EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187 The First Years, Inc. HGY Class I 2004-04-05
K040164 K-Y BRAND WARMING JELLY PERSONAL LUBRICANT Personal Products Company, Div. of Mcneil-Ppc, Inc. NUC Class II 2004-04-05
K032227 DUREX FLAVORED LATEX CONDOM Ssl Americas, Inc. HIS Class II 2004-03-29
K040521 MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH American Medical Systems, Inc. OTP Class III 2004-03-24
K031304 SYDNEY IVF PVP Cook Urological, Inc. MQL Class II 2004-03-23
K032086 KRYO ART CONTROLLED RATE FREEZER Planer Plc MQG Class II 2004-03-19
K033870 IMAGE MANAGEMENT SYSTEM Welch Allyn, Inc. HEX Class II 2004-03-12
K040295 APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS Applied Medical Resources Corp. HET Class II 2004-03-12
K033177 POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX Gunter Bissinger Medizintechnik GmbH HET Class II 2004-03-11
K033846 KAEN YIH UMBILICAL CORD CLAMP Kaen Yih Enterprise Co., Ltd. HFW Class II 2004-03-11
K040302 VERSAPOINT RESECTOSCOPIC SYSTEM Gynecare, A Div. of Ethicon, Inc. HIH Class II 2004-03-09
K033967 TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P Flir Systems LHQ Class I 2004-03-09
K032091 SMART KLAMP VARIOUS BY SIZE Emergogroup, Inc. HFX Class II 2004-03-08
K033728 TRANSVAGINAL ENDOSCOPY SET KARL STORZ Endoscopy-America, Inc. HEW Class II 2004-02-27
K032350 INFRARED SCIENCES BREASTSCAN IR SYSTEM Infrared Sciences Corp. LHQ Class I 2004-02-20

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