meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
35
Latest Decision
1996-10-10

Clearances · page 27 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K962953 DEODORANT PANTY SHIELD Paragon Trade Brands, Inc. HHL Class II 1996-10-10
K962954 DEODORANT MAXI PAD Paragon Trade Brands, Inc. HHL Class II 1996-10-10
K962962 DEODORANT PANTY LINER Paragon Trade Brands, Inc. HHL Class II 1996-10-10
K960710 CONDOM Polar Latex , Ltd. HIS Class II 1996-10-10
K963377 EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC North Eos Industries, Inc. HIB Class II 1996-10-04
K961091 KARL STORZ MODEL 203020 20 EQUIMAT KARL STORZ Endoscopy-America, Inc. HIG Class II 1996-10-03
K962090 KARL STORZ MODEL 203210 O1 UNIMAT PLUS KARL STORZ Endoscopy-America, Inc. HET Class II 1996-09-30
K963359 INSUFFLATION NEEDLE Applied Medical Resources HET Class II 1996-09-24
K962712 YSANPOINT) (MENSTRUAL) DIGITAL TAMPON Talbot S. Lindstrom HEB Class II 1996-09-10
K961860 A4907 LENS CLEANING SHEATH Olympus America, Inc. HET Class II 1996-08-29
K955672 TROJAN POLYURETHANE CONDOM (MODIFICATION) Carter Products MOL Class II 1996-08-29
K960263 CERVICAL MUCOUS ASPIRATION CATHETER Cook Urological, Inc. HFC Class II 1996-08-29
K960549 MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE Neward Enterprises, Inc. HDB Class II 1996-08-29
K955931 MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION) Advanced Medical Systems, Inc. HGM Class II 1996-08-14
K962476 UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR Tambrands, Inc. HEB Class II 1996-08-13
K961922 RDP-2 Ranfac, Corp. HET Class II 1996-08-09
K961752 H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) Ackrad Laboratories LKF Class II 1996-08-08
K960109 QUANTITATIVE SENTINEL SYSTEM Quantitative Medicine, Inc. HGM Class II 1996-08-01
K952030 LOOP/SQUARE ELECTRODE E & M Engineering, Inc. HGI Class II 1996-07-31
K962273 MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST Marlo Surgical Technology MFD Class II 1996-07-31
K960936 RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES] Origin Medsystems, Inc. HET Class II 1996-07-24
K960726 EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP Evenflo Co., Inc. HGX Class II 1996-07-22
K953813 LONDON ROYAL CONSUMER PRODUCTS LATEX CONDOMS London International U.S. Holdings, Inc. LTZ Class II 1996-07-22
K954982 KSEA SCALP BLOOD COLLECTION SET KARL STORZ Endoscopy-America, Inc. HGK Class II 1996-07-17
K946103 TRUSTEX FLAVOR CONDON IN COLORS Line One Laboratories & Trading Co. HIS Class II 1996-07-15
K961926 SANPOINT MENSTRUAL TAMPON Sanpoint AB HEB Class II 1996-07-15
K952415 DUREX, RAMSES, SHEIK London International U.S. Holdings, Inc. LTZ Class II 1996-07-15
K961424 INTRAN 500 Utah Medical Products, Inc. HFN Class II 1996-07-10
K961934 PURITAN FOAM TIP SWAB MODEL 2197 Hardwood Products Co., LP HHT Class II 1996-07-09
K961993 BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT) Devon Industries, Inc. MLS Class II 1996-07-03
K961506 MICROSPAN HYSTEROSCOPE SHEATH Imagyn Medical, Inc. HIH Class II 1996-07-03
K961695 ENDO-TECH LTD., TIPS Ratio Design Lab HFG Class II 1996-07-01
K960347 SAFETY TROCER WITH SPRINGLOADED OBDURATOR Spiess Design, Inc. HET Class II 1996-07-01
K955648 K-Y PERSONAL LUBRICANT Ortho Pharmaceutical Corp. HIS Class II 1996-06-21
K961870 PLAYTEX SLIMFIT TAMPONS Playtex Products, Inc. HIL Class II 1996-06-19
K961456 PLAYTEX TAMPONS #10296 Playtime Products, Inc. HIL Class II 1996-06-18
K955446 CONMED VCARE RETRACTOR/ELEVATOR Conmedcorp LKF Class II 1996-06-18
K954774 SHIELDED TROCAR (OBTURATOR) Gabris Surgical Corp. HET Class II 1996-06-07
K960243 CPR C-SECTION DELIVERY PACK Custom Pack Reliability MLS Class II 1996-05-23
K960239 CPR D & C TRAY Custom Pack Reliability HHK Class II 1996-05-23
K955072 LAMINARIA Cti Corp., Ltd. HDY Class II 1996-05-22
K954847 DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES Ocg Systems, Inc. HFM Class II 1996-05-22
K931220 SPERMICIDAL LUBRICATED CONDOM Monsys USA, Inc. LTZ Class II 1996-05-22
K950335 KARL STORZ RIGID TELESCOPES FOR OBSTERICS AND GYNECOLOGY KARL STORZ Endoscopy-America, Inc. HET Class II 1996-05-16
K955412 A.S.D. SAFETY TROCAR American Surgical Devices HET Class II 1996-05-14
K954775 FLO-STAT FLUID MONITORING SYSTEM Gynecare Innovation Center HET Class II 1996-05-10
K955635 VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND Welch Allyn, Inc. HEX Class II 1996-05-07
K954903 PEDI VAGINAL ASPIRATOR Cook Urological, Inc. HFC Class II 1996-04-29
K955093 ASPIRATION/COAGULATION ELECTRODE ACE-311 & ACE-511 Utah Medical Products, Inc. HGI Class II 1996-04-29
K940176 ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION Ackrad Laboratories MFD Class II 1996-04-23
K960311 PERINEOMETER Hollister, Inc. HIR Class II 1996-04-18
K952712 WHITE RIVER BATTERY-POWERED BREAST PUMP Natural Technologies, Inc. HGX Class II 1996-04-18
K960341 TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS Tambrands, Inc. HEB Class II 1996-04-17
K961119 CAREFREE PANTYLINERS Personal Products Co. HHL Class II 1996-04-17
K954955 STORC INTRAUTERINE PRESSURE CATHETER Clinical Innovations, Inc. HFN Class II 1996-04-17
K960262 CORING MORCELLATOR Cook Urological, Inc. HET Class II 1996-04-15
K955589 FERTICARE PERSONAL THERAPEUTIC VIBRATOR Multicept, Aps. KXQ Class II 1996-04-11
K951343 KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC GYNECOLOGICAL SURGICAL PROCEDURES KARL STORZ Endoscopy-America, Inc. HET Class II 1996-04-11
K955790 PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY Trylon Corp. HIC Class II 1996-03-21
K954648 FEMRX OPERASTAR SYSTEM Gynecare Innovation Center HIH Class II 1996-03-14
K960203 G.E. STERILE AMNIOCENTESIS TRAY GE Medical Systems HIO Class I 1996-03-14
K960469 DETECT CYTOLOGY BRUSH II Cook Urological, Inc. HHT Class II 1996-03-14
K954164 HYSTEROSCOPE Conceptus, Inc. HIH Class II 1996-03-12
K955679 RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY Contour Fabricators of Florida, Inc. HIO Class I 1996-03-12
K955403 OES LAPARO-THORACO VIDEOSCOPE TYPE V Olympus America, Inc. HET Class II 1996-03-11
K954351 SERIES 50XM Hewlett-Packard GmbH HGM Class II 1996-03-08
K955559 COROMETRICS FETAL MOVEMENT DETECTION KIT Ge Medical Systems Information Technologies HGM Class II 1996-03-05
K954718 ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE Ellman Intl., Inc. HEE Class II 1996-02-29
K954183 OVULATION CALCULATOR/CONCEPTION CALCULATOR Hector Vides MPT Class II 1996-02-29
K955508 ROSCH -THURMOND FALLOPIAN TUBE CATHETERIZATION SET Cook Urological, Inc. LKF Class II 1996-02-26
K955456 OES LAPARO-THORACO VIDEOSCOPE (RIGID) Olympus America, Inc. HET Class II 1996-02-22
K945145 RIA LATEX CONDOM, NONOXYNOL-9 Mbf Personal Care Sdn. Bhd. HIS Class II 1996-02-21
K955443 INTRAN PLUS Utah Medical Products, Inc. HFN Class II 1996-02-20
K942389 TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES Hogan & Hartson HET Class II 1996-02-16
K943880 RIA LATEX CONDOM Mbf Personal Care Sdn. Bhd. HIS Class II 1996-02-13
K954445 NON APPLICATOR TAMPON, UNTREATED Hygieia Healthcare , Ltd. HEB Class II 1996-02-12
K950035 SURGIFLATOR 20 W.O.M. GmbH HIF Class II 1996-02-12
K936006 SALTIME VISCOMETER Harold J. Kosasky, M.D. LHZ Class I 1996-02-09
K945611 PERITRON Cardio Design Pty. , Ltd. HIR Class II 1996-02-08
K952186 HSW GMBH HYSTEROSCOPES & ACCESSORIES Henke-Sass, Wolf GmbH HIH Class II 1996-02-06
K953583 LUBRICATED CONDOM Tactyl Technologies, Inc. HIS Class II 1996-01-26
K954942 NATRACAREN APPLICATOR TAMPON Bodywise (Uk), Ltd. HEB Class II 1996-01-25
K946207 CONQUEROR, RUMBA AND TEMPTATION Frontline Latex Products Pvt. , Ltd. HIS Class II 1996-01-24
K955119 SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES Symbiosis Corp. HIH Class II 1996-01-18
K953360 R-MED ABDOMINAL WALL ELEVATOR R-Med, Inc. HET Class II 1996-01-11
K954791 SEMINAL FLUID COLLECTION KIT II Apex Medical Technologies, Inc. HIS Class II 1996-01-05
K952527 BALLOON UTERINE STENT Cook Urological, Inc. KNA Class II 1996-01-02
K952889 INSUL-COAT/2 CERAMIC COATED ENDO MEDICAL INSTRUMENTS Materials Conversion Corp. HET Class II 1995-12-22
K954562 GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT Gynetech, Inc. HHT Class II 1995-12-22
K954619 CORDGUARD II Utah Medical Products, Inc. KNA Class II 1995-12-21
K953162 OLYMPUS HIGH FLOW INSUFFLATION UNIT Olympus America, Inc. HIF Class II 1995-12-19
K954398 INSEMI-CATH II Cook Urological, Inc. MFD Class II 1995-12-19
K945930 RIA LATEX CONDOM WITH SPERMICIDE, RIA COLOR CONDOM WITH SPERMICIDE Line One Laboratories & Trading Co. HIS Class II 1995-12-19
K940047 SPERMICIDALLY LUBRICATED CONDOM Ansell, Inc. HIS Class II 1995-12-19
K951898 VERSA-VU CooperSurgical, Inc. HIB Class II 1995-12-11
K953364 SPECULITE Trylon Corp. HET Class II 1995-12-08
K944786 RIA LATEX CONDOM & RIA COLOR CONDOMS (RED, GREEN, BLUE, ORANGE, PURPLE AND BLACK) Line One Laboratories & Trading Co. HIS Class II 1995-12-06
K952688 INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE Empi HIR Class II 1995-12-06
K941258 LATEX CONDOM Suretex, Ltd. HIS Class II 1995-12-06
K953333 MENSTRUAL TAMPON Paragon Trade Brands, Inc. HEB Class II 1995-12-06

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