meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
29
Latest Decision
1990-06-06

Clearances · page 36 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K900421 PROMISE ABSORBENT PROTECTIVE PAD Scott Health Care HHD Class I 1990-06-06
K901416 CONDOM (RUBBER) CONTRACEPTIVE Aladan Corp. HIS Class II 1990-06-04
K901084 ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO. Healthdyne Cardiovascular, Inc. KXO Class II 1990-06-01
K900838 TRANSVAGINAL TRANSDUCER ASSEMBLY Pie Medical Equipment B.V. HGL Class II 1990-05-23
K900908 CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200 Zimmer, Inc. HIG Class II 1990-05-21
K901696 LATEX CONDOMS - CODE NO. 403, 406, 421 & 1033 Allercare/Nsl, Inc. HIS Class II 1990-05-16
K897129 CONDOMS (MULTIPLE BRANDS) Sagami, Inc. HIS Class II 1990-05-16
K901668 LATEX CONDOMS - CODE NO. 402, CODE NO. 1028 Allercare/Nsl, Inc. HIS Class II 1990-05-16
K901669 LATEX CONDOMS - CODE NO. 404, NO. 424 & NO. 1000 Allercare/Nsl, Inc. HIS Class II 1990-05-16
K901667 LATEX CONDOMS - CODE NO. 401, 421 & 1002 Allercare/Nsl, Inc. HIS Class II 1990-05-16
K901557 UMBILICAL CORD CLAMP AND CUTTER Microtek-Heritage, Inc. HFW Class II 1990-05-15
K900988 AMCATH SUCTION-IRRIGATION TUBE Intl. Medical, Inc. HET Class II 1990-05-07
K895358 THERMO-5000 Medtronix Ltd., Inc. LHQ Class I 1990-05-07
K900878 OTT INSUFFLATION FILTER TUBING Gynescope Corp. HIF Class II 1990-05-07
K893039 CONDOM (RUBBER) CONTRACEPTIVE Chinteik Hygiene Products Co., Ltd. HIS Class II 1990-05-04
K895402 ENDOCOAGULATOR 2001 KLI Cabot Medical Corp. HGI Class II 1990-04-26
K900618 HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140 Huntleigh Technology, Inc. KNG Class II 1990-04-25
K893981 WATCHCHILD Monox, Inc. HGM Class II 1990-04-20
K900271 MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK Digisonics, Inc. HEM Class II 1990-04-19
K901200 TROJAN FOR WOMEN LATEX CONDOMS W/SPERMI. MODIFIED Carter Products HIS Class II 1990-04-16
K901199 TROJAN-ENZ LATEX CONDOMS W/SPERMICIDAL MODIFIED Carter Products HIS Class II 1990-04-16
K901201 TROJAN RIBBED LATEX CONDOMS W/SPERM. MODIFIED Carter Products HIS Class II 1990-04-16
K901194 TROJAN RIBBED LUBRI. LATEX CONDOMS MODIFIED LABEL Carter Products HIS Class II 1990-04-16
K901196 TROJAN FOR WOMEN LUBRI. CONDOMS MODIFIED LABELING Carter Products HIS Class II 1990-04-16
K901195 TROJAN RIBBED NATURALUBE LUBRI. CONDOMS MODIFIED Carter Products HIS Class II 1990-04-16
K901193 TROJAN PLUS LUBRI. LATEX CONDOMS (MODIFIED LABEL) Carter Products HIS Class II 1990-04-16
K901192 TROJAN-ENZ LUBRI. CONDOMS (MODIFIED LABELING) Carter Products HIS Class II 1990-04-16
K901198 TROJAN PLUS 2 LATEX CONDOMS W/SPERMICIDAL MODIFIED Carter Products HIS Class II 1990-04-16
K901197 TROJAN EXTRA STRENGTH LUBRI. CONDOMS MODI. LABEL Carter Products HIS Class II 1990-04-16
K901191 TROJAN-ENZ LATEX CONDOMS (MODIFIED LABELING) Carter Products HIS Class II 1990-04-16
K900316 MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES Irvine Scientific HDR Class II 1990-04-16
K901190 TROJANS LATEX CONDOMS (MODIFIED LABELING) Carter Products HIS Class II 1990-04-16
K900370 ONE/CIRC (CIRCUMCISION CLAMP) Bionix Development Corp. HFX Class II 1990-04-16
K900308 SPERM SELECT SYSTEM Pharmacia, Inc. HDR Class II 1990-04-13
K901152 REDYPLATE DISPOSABLE LEG PLATE Medical Accessories, Inc. HGP Class II 1990-04-04
K900359 EMBRACE Safetex Corp. HIS Class II 1990-04-02
K900360 SAXON ULTRA THIN Safetex Corp. HIS Class II 1990-04-02
K900357 GOLD CIRCLE COIN Safetex Corp. HIS Class II 1990-04-02
K895700 AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR Hollister, Inc. HDB Class II 1990-04-02
K900358 SAXON WET LUBE Safetex Corp. HIS Class II 1990-04-02
K900641 CANNULA, SUCTION UTERINE Williams Specialty Products, Inc. HHI Class II 1990-03-30
K900021 PERCU-SET(TM) E-Z-Em, Inc. HIO Class I 1990-03-29
K896118 NEZHAT/DORSEY HYDRO DISSECTION PUMP OB-GYN USE American Surgical Instruments Corp. HET Class II 1990-03-28
K901112 G.S.A. COLORED CONDOMS Ansell, Inc. HIS Class II 1990-03-27
K901111 NUDA (CURRENTLY CALLED ULTRA SENSITIVE) Ansell, Inc. HIS Class II 1990-03-27
K900642 SWIVEL ADAPTER Williams Specialty Products, Inc. HHI Class II 1990-03-19
K897100 CENTURION VAGINAL SPECULUM Tri-State Hospital Supply Corp. HIC Class II 1990-03-16
K897003 OLYMPUS HYSTERORESECTOSCOPE Olympus Corp. HIH Class II 1990-03-16
K895114 FRANK MILK PUMP Buttner-Frank GmbH HGX Class II 1990-03-05
K896917 HYSTEROSCOPE Cabot Medical Corp. HIH Class II 1990-03-05
K895225 GYNECOLOGICAL INSTRUMENTATION Gynescope Corp. HET Class II 1990-03-05
K895449 ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM Ge Medical Systems Information Technologies HGL Class II 1990-03-05
K894259 REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA Washington Regulatory Services HIG Class II 1990-03-05
K894992 QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEM Quantum Medical Systems, Inc. MAA Class II 1990-02-23
K893229 SPATULA FOR PAP SMEAR COLLECTION Medical Device Inspection Co., Inc. HHT Class II 1990-02-22
K893545 IVEX MODEL NO. BP 3000 BREASTPUMP Ivex Medical, Inc. HGX Class II 1990-02-16
K896623 SAFECON CONDOMS - PINK COLOR Quality Synthetics Intl, Inc. HIS Class II 1990-02-16
K900162 DGH A-SAN PROBE HOLDER Jedmed Instrument Co. HDR Class II 1990-02-16
K890328 ADULT RESECTOSCOPE Circon Video HIH Class II 1990-02-06
K897064 LAPAROSCOPIC ACCESS SHEATH SET Cook Ob/Gyn HET Class II 1990-02-06
K892390 FLEXIBLE IMMERSIBLE HYSTEROSCOPE Schott Fiber Optics, Inc. HIH Class II 1990-02-02
K895640 MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT Armkel, LLC HIS Class II 1990-01-23
K894030 MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR Healthdyne, Inc. HFM Class II 1990-01-22
K896122 AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED Spectramed, Inc. KXO Class II 1990-01-19
K895091 RIA (CONDOM) La Technology Sdn. Bhd. HIS Class II 1990-01-16
K895303 EVER-SHARP BIOPSY FORCEPS Southwest Medical Mfg., Inc. HFB Class I 1990-01-16
K896031 AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY) Concord/Portex HIO Class I 1990-01-12
K896339 MODIFIED LABELING ON OKAMOTO HARMONY CONDOM Okamoto USA, Inc. HIS Class II 1990-01-10
K893217 LATEX PROPHYLACTIC/RUBBER CONTRACEPTIVE Shinhen Corp. HIS Class II 1990-01-10
K897008 MENSTRUAL TAMPON Personal Products Co. HEB Class II 1990-01-08
K881263 MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER Multigon Industries, Inc. HGL Class II 1990-01-05
K896065 WALLACH CC/BRUSH Wallach Surgical Devices, Inc. HHT Class II 1990-01-04
K896989 TAMPAX TAMPON Tambrands, Inc. HEB Class II 1989-12-22
K895763 ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING Healthdyne Cardiovascular, Inc. KXO Class II 1989-12-22
K896994 KOTEX SECURITY TAMPONS (SEVERAL TYPE) Kimberly-Clark Corp. HEB Class II 1989-12-22
K897012 SCENTED OR SCENTED DEODORIZED, UNSCENTED TAMPONS Playtex Family Products, Inc. HIL Class II 1989-12-22
K895659 HUI MINI-FLEX Unimar, Inc. HIG Class II 1989-12-19
K895647 5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER Advanced Technology Laboratories, Inc. HGL Class II 1989-12-18
K894533 CONDOM (RUBBER LATEX) KILROY Rfsu HIS Class II 1989-12-18
K895028 BIRDS'N BEES CONDOMS Rfsu HIS Class II 1989-12-14
K895907 HYSTEROFLATOR 2001 Cabot Medical Corp. HIG Class II 1989-12-14
K894534 CONDOM (RUBBER LATEX) OKEIDO Rfsu HIS Class II 1989-12-14
K895894 PROFIL CONDOM (RUBBER LATEX) Rfsu HIS Class II 1989-12-14
K896115 TAMPON, PETAL SOFT PLASTIC APPLI., DEODORANT SUPER Tambrands, Inc. HIL Class II 1989-12-13
K896113 TAMPON, PETAL SOFT PLASTIC APPLICATOR, SUPER PLUS Tambrands, Inc. HEB Class II 1989-12-13
K896114 TAMPON, PETAL SOFT PLASTIC APPLI., SUPER ABSORB. Tambrands, Inc. HEB Class II 1989-12-13
K896112 TAMPAX TAMPON, FLUSHABLE APPLICATOR, SUPER PLUS Tambrands, Inc. HEB Class II 1989-12-13
K895675 PAP SMEAR TRAY Intl. Cytobrush, Inc. HHT Class II 1989-12-11
K895403 ASPIRETTE ENDOCERVICAL ASPIRATOR Unimar, Inc. HFC Class II 1989-11-29
K895519 SURE & NATURAL(TM) UNSCENTED MENSTRUAL PAD Personal Products Co. HHD Class I 1989-11-29
K895530 STANDARD CONDOM Mayer Laboratories HIS Class II 1989-11-28
K894229 NEW FREEDOM ANYDAY PANTILINERS Kimberly-Clark Corp. HHD Class I 1989-11-27
K895446 CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.) Challenge Mfg., Inc. HDB Class II 1989-11-27
K895123 5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER Advanced Technology Laboratories, Inc. HGL Class II 1989-11-13
K894036 TOITU FETAL ACTOCARDIOGRAPH, MT-332 Toitu of America, Inc. HGM Class II 1989-11-06
K895026 HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER Hewlett-Packard Co. HGL Class II 1989-11-06
K895045 MODEL 410T TELECOMMUNICATION SYSTEM Ge Medical Systems Information Technologies HGM Class II 1989-11-06
K894958 MODEL 410 ALERT AND TELECOMMUNICATION SYSTEM Ge Medical Systems Information Technologies HGM Class II 1989-11-03
K893770 TERM GUARD II DEVICE Tokos Medical Corp. HFM Class II 1989-11-03
K894415 DYMAX ENDOVAGINAL BIOPSY GUIDE Dymax Corp HGL Class II 1989-10-25

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