meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
41
Latest Decision
1989-10-24

Clearances · page 37 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K895323 MODEL DT-BAL, BALANCE SAVER Spectramed, Inc. KXO Class II 1989-10-24
K882270 MODELS 27040 & 27050 CONTI. FLOW RESECTOSCOPES KARL STORZ Endoscopy-America, Inc. HIH Class II 1989-10-20
K894846 UNSCENTED MENSTRUAL TAMPON Personal Products Co. HEB Class II 1989-10-16
K894957 DISPOSABLE PLASTIC VAGINAL SPECULA Zinnanti Surgical Instruments, Inc. HIB Class II 1989-10-12
K882224 ULTRANS DISPOSABLE INTRAUTERINE Telos Medical Corp. HFN Class II 1989-10-12
K894489 GYNECOLOGIC EXAMINATION KIT A & A Medical, Inc. HIB Class II 1989-10-05
K892888 EXTACISER PERINEAL MUSCLE EXERCISER Bivona Medical Technologies HIR Class II 1989-10-05
K891451 OLYMPUS HYF-P FLEXIBLE HYSTEROFIBERSCOPE Olympus Corp. HIH Class II 1989-10-02
K894432 MODIFIED HAM'S F-10 W/ALBUMIN Irvine Scientific HDR Class II 1989-09-22
K894405 HTF WITH ALBUMIN (CATALOG NO. 9994) Irvine Scientific HDR Class II 1989-09-22
K884692 THE SAFEGARD PERSONAL PROTECTION KIT The Safegard Protection Corp. HIS Class II 1989-09-12
K892501 WRIGHT MEDICAL FETASAFE Wright Medical Corp. HGM Class II 1989-09-12
K894646 #556 DISPOSABLE UMBILICAL CORD CLAMP (2) Alpha Unlimited, Inc. HFW Class II 1989-09-05
K892070 GENERAL IVT NEEDLE GUIDE KIT, STERILE Amedic USA HGL Class II 1989-09-05
K894891 IRRIGATOR STAND Commercial Products & Engineering Co. HDC Class II 1989-08-23
K891774 CONTIMED II BIOFEEDBACK DEV TREAT OF URIN INCONTI Hollister, Inc. HIR Class II 1989-08-23
K894264 KDF-2.3 Unimar, Inc. HDR Class II 1989-08-15
K894362 MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP Spectramed, Inc. KXO Class II 1989-08-15
K893773 LAURIER SANITARY NAPKIN Kao Corp. HHD Class I 1989-08-11
K880819 CONDOMS Universal Trade, Inc. HIS Class II 1989-08-11
K894201 GOMCO CIRCUMCISION CLAMP Zinnanti Surgical Instruments, Inc. HFX Class II 1989-08-11
K892354 ODIS - OBSTETRICAL DISPLAY INFO SYSTEM, HP M1370A Hewlett-Packard Co. HGM Class II 1989-08-08
K891996 GERBER PRECIOUS CARE ELECTRIC BREAST PUMP Gerber Products Co. HGX Class II 1989-08-07
K893725 PLAYTEX TAMPONS, NON-DEODORANT/DEODORANT Playtex Family Products, Inc. HEB Class II 1989-08-04
K894031 PHARMASEAL GENETIC AMNIOCENTESIS TRAY Baxter Healthcare Corp HIO Class I 1989-08-04
K893715 ETHICON DISPOSABLE SURGICAL TROCAR ETHICON, Inc. HET Class II 1989-08-03
K892846 ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE Cook Ob/Gyn HIO Class I 1989-07-14
K884925 THE GREAT WALL CONDOM Pacific Sales & Development Corp. HIS Class II 1989-06-23
K892820 FORCEPS, SURGICAL, GYNECOLOGICAL The South India Surgical Co. Pvt. , Ltd. HCZ Class II 1989-06-22
K890125 SANITARY NAPKIN PADS Landen Corp. HHD Class I 1989-06-21
K890819 HSV-CHECK(TM) TEST KIT Diagnostic Technology, Inc. HIS Class II 1989-06-20
K892001 DEX-CELL HYSTEROSCOPY FLUID DELIVERY DEVICE Dexide, Inc. HIG Class II 1989-06-16
K892220 LAMINARIA TENT Berkeley Medevices HDY Class II 1989-06-14
K893503 SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS Laurel Medical Corp. HFN Class II 1989-06-12
K890637 EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE Elscint, Inc. HEM Class II 1989-06-12
K891595 MODEL 116 FETAL MONITOR Ge Medical Systems Information Technologies HGM Class II 1989-06-12
K891297 PLAYTEX PORTABLES NON-DEODORANT & DOED. TAMPONS Playtex Family Products, Inc. HIL Class II 1989-06-08
K891997 CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER Corometrics Medical Systems, Inc. HFM Class II 1989-06-08
K891474 TAMPAX ULTRAFIT PANTY SHIELDS - MOFIFICATION Tambrands, Inc. HHD Class I 1989-06-07
K891473 TAMPAX ULTRAFIT PANTY SHIELDS/DEDORANT-MODIFICATIO Tambrands, Inc. HHL Class II 1989-06-07
K882084 GENESIS TM FETAL SYSTEM Pediatric Diagnostic Service HGM Class II 1989-05-26
K891290 SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER Cook Ob/Gyn HES Class II 1989-05-23
K890407 THE SAXON SPERMICIDAL CONDOM W/2 YEAR EXPIRATION Circle Rubber Corp. HIS Class II 1989-05-16
K890588 GENTLE EXPRESSIONS ELECTRIC BREAST PUMP Healthteam HGX Class II 1989-05-16
K891351 NEWPORT LATERAL VAGINAL RETRACTOR Simpson/Basye, Inc. KOH Class I 1989-05-11
K892693 VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT Zinnanti Surgical Instruments, Inc. KOH Class I 1989-05-11
K891465 OBSTETRIC CUP (MODIFICATION) Go Medical Industries Pty. , Ltd. HDB Class II 1989-05-11
K891398 RETRACTOR RODS Zinnanti Surgical Instruments, Inc. KNA Class II 1989-05-11
K890848 CERVEX-BRUSH Unimar, Inc. HHT Class II 1989-05-11
K890655 NEW FREEDOM THIN DEODORANT MAXI PADS Kimberly-Clark Corp. HHL Class II 1989-05-01
K881507 ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES Hgm Medical Laser Systems, Inc. HHR Class II 1989-04-27
K890869 BARD HYSTEROSALPINGOGRAPHY CATHETERS C.R. Bard, Inc. HES Class II 1989-04-25
K890706 CYTOBRUSH Laboratoire Ccd C/O Washington Regulatory Services HHT Class II 1989-04-25
K890013 KOTEX SUPER MAXI PADS Kimberly-Clark Corp. HHT Class II 1989-04-25
K884454 SAFECON CONDOMS - RIBBED Quality Synthetics Intl, Inc. HIS Class II 1989-04-25
K890654 NEW FREEDOM THIN SUPER & UNSCENTED, MAXI & SUPER Kimberly-Clark Corp. HHD Class I 1989-04-25
K881329 FETAL DOPPLER FOR ULTRAMARK 4 AND 8 Advanced Technology Laboratories, Inc. HEM Class II 1989-04-14
K890463 ULTRASOUND PROCEDURE TRAY AMNICENTESIS TRAY Critical Specialties, Inc. HIO Class I 1989-04-07
K890863 TROJAN FOR WOMEN Armkel, LLC HIS Class II 1989-04-04
K890307 MITYVAC M STYLE VACUUM EXTRACTOR, DISPOSABLE Neward Enterprises, Inc. HDB Class II 1989-03-31
K884470 KIMONO PLUS OTHERS (MULTIPLE) CONDOMS Mayer Laboratories HIS Class II 1989-03-31
K884469 ORION PLUS W/NONOXYNOL-9 OTHERS (MULTIPLE) CONDOMS Mayer Laboratories HIS Class II 1989-03-31
K890301 SHEPARD INTRAUTERINE INSEMINATION CATHETER Cook Ob/Gyn HDR Class II 1989-03-31
K884468 SUPER MAXX OTHERS (MULTIPLE) CONDOMS Mayer Laboratories HIS Class II 1989-03-31
K891399 CORSON MYOMA GRASPING FORCEPS Zinnanti Surgical Instruments, Inc. KNA Class II 1989-03-29
K891402 UTERINE CLAMPS Zinnanti Surgical Instruments, Inc. HGC Class I 1989-03-29
K891350 NEWPORT CERVICAL MANIPULATOR Simpson/Basye, Inc. HDC Class II 1989-03-29
K883524 SAFECON CONDOMS W/SPERMICIDAL LUBRICANT Quality Synthetics Intl, Inc. HIS Class II 1989-03-29
K891397 GREENE-ARMYTAGE HEMOSTATIC FORCEPS Zinnanti Surgical Instruments, Inc. KNA Class II 1989-03-29
K891349 CAMPION CERVICAL HOOK Simpson/Basye, Inc. HDC Class II 1989-03-29
K890139 TOITU DOPPLER FETUS DETECTOR, FD-400D Toitu of America, Inc. KNG Class II 1989-03-29
K890565 GELLHORN PESSARY 33410 VARIOUS SIZES Medi-Source, Inc. HHW Class II 1989-03-29
K891347 REID ENDOCERVICAL SPREADER Simpson/Basye, Inc. HDC Class II 1989-03-29
K890897 CENTURION CIRCLAMP Tri-State Hospital Supply Corp. HFX Class II 1989-03-28
K891388 1570 - FETAL BLOOD SAMPLING KIT Transidyne General Corp. HGW Class II 1989-03-28
K890787 O-020 LASER INDIRECT OPHTHALMOSCOPE Hgm Medical Laser Systems, Inc. HGF Class II 1989-03-24
K885316 DISPOSABLE INTRAUTERINE PRESSURE KIT MODEL 13972A Hewlett-Packard Co. KXO Class II 1989-03-23
K891032 ENDO CERVICAL CURETTE - EVANS, RANDALL, GUSBERG Zinnanti Surgical Instruments, Inc. HHT Class II 1989-03-22
K891041 MIYA SPECULUM Zinnanti Surgical Instruments, Inc. HDF Class I 1989-03-22
K891043 ROTO FIT BIOPSY FORCEPS Zinnanti Surgical Instruments, Inc. HFB Class I 1989-03-22
K891045 MIYA HOOK Zinnanti Surgical Instruments, Inc. KNA Class II 1989-03-22
K891035 NEEDLE EXTENSIONS Zinnanti Surgical Instruments, Inc. KOH Class I 1989-03-22
K891048 OVUM FORCEPS-BARRET,JAVERTS,WILLET,HANSEN,COREY,MC Zinnanti Surgical Instruments, Inc. KNA Class II 1989-03-22
K891046 SOPHER AND BIERER OVUM FORCEPS Zinnanti Surgical Instruments, Inc. KNA Class II 1989-03-22
K891029 CERVICAL DILATORS PRATT,HAWKIN,KLEEGMAN,DENN.,VALL Zinnanti Surgical Instruments, Inc. HDQ Class I 1989-03-17
K891037 WEIGHTED SPECULA-STEINER,HENROTIN,BERLAND,GARRIGUE Zinnanti Surgical Instruments, Inc. HFD Class II 1989-03-17
K891049 ZEPPELIN SCISSORS Zinnanti Surgical Instruments, Inc. KOH Class I 1989-03-17
K891027 ZSI BIOPSY FORCEPS Zinnanti Surgical Instruments, Inc. HFB Class I 1989-03-17
K891038 VAGINAL RETRACTORS - KRISTELLER, DELEE, BREISKY Zinnanti Surgical Instruments, Inc. HDL Class I 1989-03-17
K891030 IUD HOOKS - SIMPLE, UNIVERSAL AND SKLAR Zinnanti Surgical Instruments, Inc. HHF Class I 1989-03-17
K891028 UTERINE CANNULA - KAHN, JARCO, CORSON, RATCHET Zinnanti Surgical Instruments, Inc. HIG Class II 1989-03-17
K891044 LASER SPECULA Zinnanti Surgical Instruments, Inc. HDF Class I 1989-03-17
K891042 MICRO SURGERY NEEDLE HOLDERS Zinnanti Surgical Instruments, Inc. KNA Class II 1989-03-17
K891033 ATRAUMATIC TENACULA Zinnanti Surgical Instruments, Inc. HDC Class II 1989-03-17
K891047 ZEPPELIN FORCEPS Zinnanti Surgical Instruments, Inc. HCZ Class II 1989-03-17
K891039 MICRO SURGERY FORCEPS Zinnanti Surgical Instruments, Inc. KNA Class II 1989-03-17
K891034 TISCHLER BIOPSY FORCEPS Zinnanti Surgical Instruments, Inc. HFB Class I 1989-03-17
K891036 HYSTERECTOMY FORCEPS - (SEVERAL MODELS) Zinnanti Surgical Instruments, Inc. HCZ Class II 1989-03-17
K891040 MICRO SURGERY SCISSORS Zinnanti Surgical Instruments, Inc. KNA Class II 1989-03-17
K890283 CYTEX ONE AND CYTEX TWO Anderson Winn Paper Co. HHT Class II 1989-03-16

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