meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
44
Latest Decision
1979-07-30

Clearances · page 46 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K790875 MONOJECT ENDOMETRIAL SAMPLING KIT Sherwood Medical Co. HHK Class II 1979-07-30
K790851 VAGI-PRESS #401 C. Intl. KOH Class I 1979-07-30
K790923 MI-MARK ENDOCERVICAL SAMPLING SET Simpson/Basye, Inc. KNA Class II 1979-06-22
K790761 FETASONDE MODEL 2108 Roche Medical Electronics, Inc. HGM Class II 1979-06-01
K790678 INTRAUTERINE CATHETER TIP Sonicaid, Inc. KXO Class II 1979-05-11
K790385 KOTEX TUBE AND STICK TAMPON Kimberly-Clark Corp. HEB Class II 1979-03-22
K790418 MODEL 8100 PRE-FILLED INTRAUTERINE Ge Medical Systems Information Technologies KXO Class II 1979-03-21
K790139 MONITOR, OFFICE MODEL 140 Ge Medical Systems Information Technologies HGM Class II 1979-02-16
K790043 TRACOR, CANNULA, BICEPTS BIPOLAR Neomed Corp. HIN Class II 1979-02-08
K781916 FLEXT-THERM E-Z-Em, Inc. KXZ Class III 1979-02-02
K790032 DISPOSABLE VACUUM CURETTE British Marketing Ent., Ltd. HCY Class I 1979-02-01
K782054 LASER, CO2 SURGICAL Cavitron Corp. HHR Class II 1979-01-17
K782111 PADS, MINI, MAXI DEODORANT Intl. Playtex, Inc. HHL Class II 1979-01-08
K782112 PADS, MINI, MAXI Intl. Playtex, Inc. HHD Class I 1979-01-08
K782067 DILATOR, MIZUTANI LAMINARIA TENT British Marketing Ent., Ltd. HDY Class II 1979-01-03
K782083 VAGATEX Vagatex HIR Class II 1979-01-03
K781767 INSTRUMENT CURNETT MINI-CONER BIOPSY C.R. Bard, Inc. KOH Class I 1978-12-07
K781766 UTERINE SOUND, BURNETT DISPOSABLE C.R. Bard, Inc. HHM Class I 1978-12-07
K781913 INSUFFALATOR LAPARAOSCOPIC Kli HIF Class II 1978-12-04
K781830 BIOPSY KIT 781101, ASPIRATION Vista Products, Inc. HHK Class II 1978-11-15
K781863 DEVICE, FEMALE INCONTINENCE Eschmann Bros. & Walsh , Ltd. HHW Class II 1978-11-06
K781548 UMBILICAL CORD CLAMP Hollister, Inc. HFW Class II 1978-10-17
K781359 MODEL 80032A, OBSTETRICAL TELEMETRY Hewlett-Packard Co. HGM Class II 1978-09-26
K781109 FORCEPS, ELECTROSURGICAL Kli HIN Class II 1978-09-14
K781470 MODESS* BELTLESS FEMININE NAPKIN Personal Products Co. HHD Class I 1978-09-07
K781360 MODEL 80100A, PATIENT DATA MEMORY Hewlett-Packard Co. HGM Class II 1978-09-07
K781207 DOUCHE KIT, SOMETHING PERSONAL Chatten Drug & Chemical Co. HED Class I 1978-08-10
K781085 ASSURE NATURAL FIT TAMPON Personal Products Co. HIL Class II 1978-07-17
K781089 ONE INCISION BI-POLAR ELECTRO. FORCEPS Kli HIN Class II 1978-07-17
K780460 DENTAL AIR BRUSH M. Joel Gebhart, D.D.S. KOH Class I 1978-06-28
K780876 ULTRASONIC IMAGER Air-Shields, Inc. HEM Class II 1978-06-27
K780955 SCISSORS, HOOK, ELECTROSURGICAL Kli KNF Class II 1978-06-22
K780954 SCISSORS, HOOK, ELECTROSURGICAL Kli KNF Class II 1978-06-22
K780648 MODIFIED UNTREATED TAMPAX TAMPONS Tampax, Inc. HEB Class II 1978-05-31
K780587 GYNESURG Polamedco, Inc. KNA Class II 1978-05-25
K780487 FETAL MONITORING SYSTEM Sonicaid, Inc. HFO Class II 1978-05-09
K780387 VABRA ABORTION UNIT Cooper Laboratories HHI Class II 1978-04-12
K780349 VAGINAL RETRACTOR Edward Weck, Inc. HDL Class I 1978-03-14
K780035 MINIVISOR Metrix Teknika, Inc. HEL Class II 1978-03-06
K780243 TAMPON, RELY MODIFIED Procter & Gamble Mfg. Co. HEB Class II 1978-03-02
K780177 FETAL MONITOR MODEL 112 Ge Medical Systems Information Technologies HGM Class II 1978-03-02
K780176 DISPLAY SYSTEM MODEL 428 Ge Medical Systems Information Technologies HGM Class II 1978-03-02
K780058 TAMPON, HEAVY DUTY, & STICK Kimberly-Clark Corp. HIL Class II 1978-01-26
K772297 INSUFFLATOR, MODEL G100 & 200 Kli HIF Class II 1978-01-05
K772230 CANNULA, PERFUSION, FALLOPIAN TUBE J. Sklar Mfg. Co., Inc. LKF Class II 1978-01-03
K772229 MINICLAMPS, STABILIZ., FALLOPIAN TUBE J. Sklar Mfg. Co., Inc. HCZ Class II 1978-01-03
K772181 PROPHYLACTIC Om Industries, Inc. HIS Class II 1977-12-20
K772242 LAPAROSCOPY CONSOLE MODEL VIII Kli HET Class II 1977-12-20
K772220 PROBE, COAGULATION ACCESSORY Kli KNF Class II 1977-12-13
K772185 LAPAROSCOPE W/REMOVABLE OPTICS Kli HET Class II 1977-11-30
K771962 CAMERA ADAPTER FOR ENDOSCOPES Kli HET Class II 1977-11-21
K772023 OB/GYN LASER, MODEL 920 Photon Sources HHR Class II 1977-11-18
K772121 ASPIRATOR & PROBE, CYTOLOGY, ENDOMET. Smithkline Diagnostics, Inc. HHK Class II 1977-11-17
K771548 SILASTIC BRAND INTRAVAGINAL TARSETTE Dow Corning Corp. Healthcare Industries Materials HHW Class II 1977-11-07
K771869 DIAG. ULTRASOUND B-SCANNER Accusonics, Inc. HGL Class II 1977-11-02
K771942 TILT 10, CATALOG #S-2600 Affiliated Hospital Products, Inc. HDD Class II 1977-10-27
K771961 DUAL INCISION TUBAL OCCLUS. BAND APPLI. Kli HET Class II 1977-10-25
K771958 12MM SELF-SEALING TROCAR & CANNULA Kli HET Class II 1977-10-25
K771959 8MM SELF-SEALING TROCAR & CANNULA Kli HET Class II 1977-10-25
K771960 TUBAL OCCLUSION INSERTER/LAPAROSCOPE Kli HET Class II 1977-10-25
K771964 8MM TROCAR & CANNUAL W/STOPCOCK Kli HET Class II 1977-10-25
K771963 SINGLE INCISION TUBAL OCCLU. BAND APPL. Kli HET Class II 1977-10-25
K771816 ROCHE AXISCAN 5 Roche Medical Electronics, Inc. HEM Class II 1977-10-19
K771547 PETITES BETWEEN-PERIOD PROTECTORS 3M Company HHL Class II 1977-09-20
K771558 SILASTIC BRAND OBSTETRICAL VACUUM CUP Dow Corning Corp. Healthcare Industries Materials HDB Class II 1977-09-20
K770986 FLEXI-THERM FILM E-Z-Em, Inc. KXZ Class III 1977-09-12
K771541 FETAL MONITORING SYSTEM Air-Shields, Inc. HGM Class II 1977-08-25
K771553 SPIRAL SCALP ELECTRODE, 14499A Hewlett-Packard Co. HGP Class II 1977-08-25
K771151 ARTIUS SYSTEM General Electric Co. HGL Class II 1977-08-04
K771195 FETAL/MATERNAL REPEATER - 21596A Hewlett-Packard Co. HGM Class II 1977-08-03
K771196 MARKER GENERATOR MODULES - 21597A Hewlett-Packard Co. HGM Class II 1977-08-03
K771379 FETAL MONITORING SYS. MODEL FM3R Sonicaid, Inc. HGM Class II 1977-08-03
K771194 FETAL/MATERNAL ALRM MODULE - 21595A Hewlett-Packard Co. HGM Class II 1977-08-03
K771344 GUSBERG HYSTERECTOMY CLAMP J. Sklar Mfg. Co., Inc. HGC Class I 1977-07-27
K771149 ENDOMETRIAL ASPIRATION BIOSPY KIT 182341 C.R. Bard, Inc. HHK Class II 1977-07-27
K771211 DOPPLER (UTD-5 & UTD-6) Terumo America, Inc. HEK Class II 1977-07-14
K771181 VAGINAL ILLUMINATOR, MODEL 78570 Welch Allyn, Inc. HDG Class I 1977-07-14
K770873 CIRCUMCISION KIT American Hospital Supply Corp. FHG Class II 1977-07-11
K770438 CART, PROCEDURES I E Industries HDD Class II 1977-07-01
K771106 FORCEPS, OB, NON-COMPRESSIVE Zeppelin Medizinlechnik GmbH HDA Class II 1977-07-01
K770641 MINI-CONER TM Medical Testing System, Inc. KNA Class II 1977-06-24
K771012 ASSURE DEODORANT TAMPONS Personal Products Co. HIL Class II 1977-06-24
K770412 PROPHALACTICS Jamar Health Products HIS Class II 1977-06-17
K770896 COLPOSCOPE MODEL II Dynatech Cryomedical Co. HEX Class II 1977-06-03
K770904 PROBE, BLOOD FLOW DETECTOR PLUG-IN Medsonics KNG Class II 1977-05-26
K770678 ELC-THERMO-SYSTEM Cutter Laboratories, Inc. KXZ Class III 1977-05-25
K770778 MAXI-PADS, STAYFREE Personal Products Co. HHD Class I 1977-05-20
K770697 COLPOSCOPE SYSTEM Richard Wolf Medical Instruments Corp. HEX Class II 1977-05-20
K770692 MONITOR, FETAL, NO. L04-1100 Brattle Instrument Corp. HGM Class II 1977-04-26
K770727 MANIPULATOR & INJECTOR, UTERINE National Catheter Co. Div. Mallinckrodt KNA Class II 1977-04-26
K770674 CURETTE, UTERINE, VACUUM ASPIRATING American Hospital Supply Corp. HHK Class II 1977-04-26
K770644 ULTRASOUND B-SCANNING SYSTEM Unirad Corp. HEM Class II 1977-04-14
K770437 TABLE, EXAMINATION I E Industries KNC Class II 1977-03-23
K770297 FETAL MONITOR, PART #100-11009 Brattle Instrument Corp. HGM Class II 1977-03-09
K770292 MONITOR, FETAL HEART, MODEL 1980 Berkeley Bio-Engineering HGI Class II 1977-03-09
K770379 TROCAR SLEEVE SYSTEM Richard Wolf Medical Instruments Corp. HET Class II 1977-03-09
K770296 FETAL MONITOR, PART #101-11009 Brattle Instrument Corp. HGM Class II 1977-03-09
K770378 LAPAROSCOPE, FIBER LIGHT, PALMER-JACOBS Richard Wolf Medical Instruments Corp. HET Class II 1977-03-09
K770295 ABDOMINAL ECG PROCESSOR FOR FETAL MONI. Brattle Instrument Corp. HGI Class II 1977-03-09
K770245 ABDOMINAL FETAL ECG MODULE Mennen Greatbatch Electonics KXN Class II 1977-02-14

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