meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
42
Latest Decision
1990-12-05

Clearances · page 35 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K904142 GRASPING FORCEPS/ALIGATOR FORCEPS/NEEDLE HOLDERS Baxter Healthcare Corp HET Class II 1990-12-05
K904104 ENDOPATH UNSHIELDED DISPOSABLE SURGICAL TROCAR ETHICON, Inc. HET Class II 1990-12-05
K904375 KIMONO PLUS Mayer Laboratories HIS Class II 1990-11-26
K904453 LABELLING MODIFICATION TO MAXX PLUS Mayer Laboratories HIS Class II 1990-11-23
K904840 ORION PLUS/MODIFICATION Mayer Laboratories HIS Class II 1990-11-20
K902722 BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM Davol, Inc. HET Class II 1990-11-16
K903623 MODEL600 UTERINE ACTIVITY MONITOR Corometrics Medical Systems, Inc. HFM Class II 1990-11-07
K903560 CLARKE LAPAROSCOPIC LIGATOR AND FORCEPS Marlo Surgical Technology HET Class II 1990-11-06
K902119 SAFEBRIS STERILE CIRCUMCISION KIT Kedumin Kits, Ltd. FHJ Class II 1990-11-05
K904160 CYTOSMEAR BRUSH Brooke Intl. HHI Class II 1990-11-02
K904273 MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB. Carter Products LTZ Class II 1990-10-31
K902104 ORION WATCHGUARD Orion Industries HFM Class II 1990-10-25
K903780 AUTO SUTURE LAPAROSCOPY ACCESSORY KIT United States Surgical, A Division of Tyco Healthc HET Class II 1990-10-23
K903348 ULTRASONIC PULSED DOPPLER IMAGING SYSTEM Advanced Technology Laboratories, Inc. HGL Class II 1990-10-22
K902190 FETAL PULSE DETECTOR MODEL DOP-1 Advanced Medical Systems, Inc. HEK Class II 1990-10-22
K903206 AUTO SUTURE(R) ENDOSCOPIC SCISSORS United States Surgical, A Division of Tyco Healthc HET Class II 1990-10-17
K903600 ESPI MICRO GRASPER,DOUBLE-ACTION,INSULATED,#8250-N Dixon Medical, Inc. HET Class II 1990-10-17
K903599 ESPI DOUBLE-ACTION INSULATED GRASPER, #8203-N Dixon Medical, Inc. HET Class II 1990-10-17
K903598 ESPI DOUBLE-ACTION GRASPER, INSULATED, #8202-N Dixon Medical, Inc. HET Class II 1990-10-17
K903187 LAPAROSCOPIC CATHERTER Cook Ob/Gyn HET Class II 1990-10-12
K903124 LAPAROSCOPIC ACCESS SHEATH SET Cook, Inc. HET Class II 1990-10-12
K903146 HYSTEROSCOPY SHEATH SET Cook, Inc. HIH Class II 1990-10-12
K903205 AUTO SUTURE(R) ENDOSCOPIC CLAMP United States Surgical, A Division of Tyco Healthc HDA Class II 1990-10-11
K901288 DAVOL SCOPE IRRIGATION SYSTEM C.R. Bard, Inc. HIG Class II 1990-10-10
K904026 INFLAT-O-BALL Milex Products, Inc. HHW Class II 1990-10-10
K902242 ENDOCERVICAL ASPIRATOR Innovative Medical Products, Inc. HFC Class II 1990-10-09
K904358 MODEL 855 ENHANCED PERFORMANCE REMOTE TERMINAL Ge Medical Systems Information Technologies HGM Class II 1990-10-05
K902171 MINISPACE(TM) IUI CATHETER Pharmacia, Inc. HDR Class II 1990-10-05
K902032 O. B. PACK IV Customed, Inc. HFC Class II 1990-09-28
K903973 GARDOSI BIRTHING CUSHION Graphic Controls Corp. KNC Class II 1990-09-27
K903707 DEFLECTING WIRE GRASPER Cook, Inc. HCZ Class II 1990-09-26
K902552 GERBER PRECIOUS CARE ELECTRIC BREAST PUMP Gerber Products Co. HGY Class I 1990-09-26
K902975 TWIN BALLOON INJECTOR Zinnanti Surgical Instruments, Inc. LKF Class II 1990-09-26
K903207 AUTO SUTURE ENDOSCOPIC SUCTION/IRRIGATRION DEVICE United States Surgical, A Division of Tyco Healthc HET Class II 1990-09-25
K901413 CORE DISPOSABLE INSUFFLATION TUBING Core Dynamics, Inc. HES Class II 1990-09-24
K900808 RAPID AUTOMATIC PNEUMOPERITONEUM-I Trek Medical Products, Inc. HIF Class II 1990-09-19
K902258 5 MM IRRIGATION/ASPIRATION FIBER PROBE Hgm Medical Laser Systems, Inc. HET Class II 1990-09-19
K902658 GYNESCOPE MONOPOLAR FORCEPS AND ELECTRODES Gynescope Corp. KNF Class II 1990-09-19
K902657 GYNESCOPE LAPAROSCOPIC FORCEPS Gynescope Corp. HET Class II 1990-09-19
K903080 DISPOSABLE PLASTIC VAGINAL SPECULUM Dawnex Industries, Inc. HIB Class II 1990-09-19
K896701 TEFLON CERVICAL ACCESS SET Cook Ob/Gyn HDQ Class I 1990-09-13
K903597 ESPI MICRO SCISSORS, #8150 Dixon Medical, Inc. HET Class II 1990-09-12
K903595 ESPI CLAW FORCEP, #8302, 10MM, 30CM Dixon Medical, Inc. HET Class II 1990-09-12
K903596 ESPI REDUCER SLEEVE, #8415 Dixon Medical, Inc. HET Class II 1990-09-12
K903591 ESPI HOOK/UNIVERSAL SCISSORS, # 8101 Dixon Medical, Inc. HET Class II 1990-09-12
K900966 EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE Hitachi Medical Corp. of America HGL Class II 1990-09-12
K903602 ESPI NON-INSULATED DOUBLE-ACTION GRASPER, #8203 Dixon Medical, Inc. HET Class II 1990-09-12
K903594 ESPI TISSUE GRASPER/NEEDLE HOLDER, #8201 Dixon Medical, Inc. HET Class II 1990-09-12
K903601 ESPI NON-INSULATED DOUBLE-ACTION GRASPER #8204 Dixon Medical, Inc. HET Class II 1990-09-12
K903592 ESPI CLAW FORCEP, #8301, 5MM, 30 CM LENGTH Dixon Medical, Inc. HET Class II 1990-09-12
K903744 PHYSICIAN'S CHOICE Advance Medical Device, Inc. HIB Class II 1990-09-12
K903593 ESPI APPLICATOR SLEEVE, #8410 Dixon Medical, Inc. HET Class II 1990-09-12
K897070 ENDOBRUSH(TM) DEVICE; OMNIBRUSH Intl. Cytobrush, Inc. HFE Class II 1990-09-10
K902591 CYTETTE(TM) CYTOLOGY BRUSH Birchwood Laboratories, Inc. HHT Class II 1990-09-10
K902589 CYTOSET(TM) Birchwood Laboratories, Inc. HHT Class II 1990-09-10
K896524 SPIRTOS COAXIAL CATHETER SET Cook Ob/Gyn HET Class II 1990-09-05
K902802 FETAL MONITORING TRANSDUCER STRAP Macon & Co., Inc. HGM Class II 1990-09-04
K903528 LAPAROSCOPE Intramed Laboratories, Inc. HET Class II 1990-09-04
K902313 LM-1Z ZOOM SCOPE Leisegang Medical, Inc. HEX Class II 1990-09-04
K902563 MONOSCOPY(TM) BRAND, TROCAR REDUCER SET Dexide, Inc. HET Class II 1990-09-04
K902694 COAXIAL CATHETER SET Cook Ob/Gyn HDR Class II 1990-08-28
K902954 OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC) Permobil AB HFC Class II 1990-08-23
K903316 ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER Ge Medical Systems Information Technologies HGL Class II 1990-08-22
K901142 MER MULTIPLANE VAGINAL PROBE (MVP) Medical Equipment Resources HGL Class II 1990-08-22
K901690 WHENEVER(R) UNSCENTED SUPER MAXI PAD Marcal Paper Mills, Inc. HHD Class I 1990-08-21
K902273 O. B. PACK III Customed, Inc. HHD Class I 1990-08-21
K902160 SABA CONFORT MENSTRUAL PAD Valle & Assoc. HHD Class I 1990-08-21
K902271 O. B. PACK I Customed, Inc. HHD Class I 1990-08-15
K902272 O. B. PACK II Customed, Inc. HHD Class I 1990-08-15
K902804 EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT Okamoto USA, Inc. HIS Class II 1990-08-13
K900505 SONOACE 88 PORTABLE ULTRASOUND SCANNER Medison Co., Ltd. HEM Class II 1990-08-10
K902830 PERI-BOTTLE Orion Life Systems, Inc. HED Class I 1990-08-06
K901344 MEDELA BATTERY OPERATED BREAST PUMP Medela, Inc. HGX Class II 1990-08-06
K903213 ARTHROSCOPIC SURGICAL KNIVES MODELS 1001 AND 1002 Percutaneous Technologies HEX Class II 1990-07-27
K901442 BAXTER D & C TRAY Baxter Healthcare Corp HCY Class I 1990-07-26
K901954 AMEDA/EGNELL DOLPHIN UMBILICAL CORD SEVERING DEVIC Hollister, Inc. HFW Class II 1990-07-26
K901643 ISOFLO(TM) AMNIOCENTESIS TRAY Healthdyne Cardiovascular, Inc. HIO Class I 1990-07-25
K902509 SAXON RIBBED CONDOMS Safetex Corp. HIS Class II 1990-07-24
K902655 GYNESCOPE LAPAROSCOPES Gynescope Corp. HET Class II 1990-07-13
K897007 UNSCENTED MENSTRUAL TAMPON Personal Products Co. HEB Class II 1990-07-13
K897140 THIN CONDOM RAMSES & SHEIK Schmid Laboratories, Inc. HIS Class II 1990-07-13
K897191 BSI MODEL TIP Bales Scientific, Inc. LHQ Class I 1990-07-13
K895909 SONICAID MODEL VASOFLO 4 Oxford Medilog, Inc. MAA Class II 1990-07-09
K902516 NEW LENGTH SUGITA APPLIERS Sims Surgical, Inc. HIC Class II 1990-07-03
K901593 IMEX DOP-TONE II Imex Medical Systems, Inc. KNG Class II 1990-07-02
K900480 M1350A FETAL MONITOR (INTRAPARTUM) Hewlett-Packard Co. HGM Class II 1990-07-02
K902656 GYNESCOPE LAPAROSCOPIC TROCARS AND SLEEVES Gynescope Corp. HET Class II 1990-06-29
K901897 ZEPPELIN FORCEPS Kirwan Surgical Products, Inc. HCZ Class II 1990-06-29
K896107 RUBBER CONTRACEPTIVE Banrub Sdn Bhd HIS Class II 1990-06-29
K896960 INTRAUTERINE INSEMINATION CATHETERS C.R. Bard, Inc. HDR Class II 1990-06-26
K895857 CONTINUOUS IRRIGATION RESECTOSCOPE SYST/GYNECOLOGY Richard Wolf Medical Instruments Corp. HIH Class II 1990-06-22
K901664 CAREFREE(TM) FESTIVA PANTYSHIELDS Personal Products Co. HHD Class I 1990-06-22
K902555 AMCATH COAGULATION PROBE Intl. Medical, Inc. HFG Class II 1990-06-20
K901202 TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED Carter Products HIS Class II 1990-06-19
K901407 CORE DISPOSABLE TROCARS Core Dynamics, Inc. HET Class II 1990-06-08
K902019 MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS Gynescope Corp. HDF Class I 1990-06-07
K900679 MINT SCENTED CONDOMS Schmid Laboratories, Inc. HIS Class II 1990-06-07
K902049 CROAK OVARIAN BIOPSY FORCEP Gynescope Corp. HFB Class I 1990-06-07
K896987 RUBBER CONDOM (NON-COLORED) Hankook Latex Gongup Co., Ltd. HIS Class II 1990-06-06
K896142 RUBBER CONTRACEPTIVE (CONDOM) Guangzhou No. 11 Rubber Factory HIS Class II 1990-06-06

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