meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
36
Latest Decision
1994-12-27

Clearances · page 30 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K933723 CONCEPTUS UTERINE CATHETER Conceptus, Inc. LKF Class II 1994-12-27
K933816 SONICAID MODEL P110 FETAL HEAR DETECTOR Oxford Instruments, Plc. HEL Class II 1994-12-22
K934799 CONMED TROGARD Conmedcorp HET Class II 1994-12-21
K944834 UNSCENTED MENSTRUAL TAMPONS Tambrands, Inc. HEB Class II 1994-12-21
K944297 KARL STORZ INSULATED SCISSORS KARL STORZ Endoscopy-America, Inc. KNF Class II 1994-12-15
K944300 KARL STORZ INSULATED BIOPSY FORCEPS KARL STORZ Endoscopy-America, Inc. KNF Class II 1994-12-15
K942447 HASSON OPEN LAPAROSCOPY CANNULA Linvatec Corp. HET Class II 1994-12-15
K921871 HYSTEROMAT(TM) 3700 F.M. Wiest USA, Inc. HIG Class II 1994-12-15
K941251 FINESSE IEC/601 Utah Medical Products, Inc. HGI Class II 1994-12-12
K942843 CERVEX-BRUSH(R), STERILE, SPATULA, CERVICAL, CYTOLOGY Rovers Diagnostic Devices HHT Class II 1994-12-08
K935377 R AND D BATTERIES R & D Batteries, Inc. HGM Class II 1994-12-05
K935301 R & D BATTERIES, INC. PART NUMBERS 5235, 5506 & 5050 R & D Batteries, Inc. HGM Class II 1994-12-05
K936309 DELUXE MAGMAG BREAST PUMP Pigeon Corp. HGX Class II 1994-11-30
K924502 REUSABLE MENSTRUAL PAD Keema and Co. HHD Class I 1994-11-30
K931065 LAPAROVIEW Northgate Technologies, Inc. HET Class II 1994-11-30
K935249 ADVANCED MAGMAG AC/BATTERY BREAST PUMP Pigeon Corp. HGX Class II 1994-11-22
K943508 INSUFFLATOR TUBING WITH FILTER Stryker Endoscopy HET Class II 1994-11-17
K944245 DYNABITE LAPAROSCOPIC FORCEPS Portlyn Corp. HET Class II 1994-11-15
K926517 ELMED LBC 50-P Elmed, Inc. HIN Class II 1994-11-15
K943954 ASPEN SURGICAL SYSTEMS INSUFFLATION TUBING SET WITH FILTER Conmedcorp HIF Class II 1994-11-15
K943776 COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIES Richard Wolf Medical Instruments Corp. HIN Class II 1994-11-03
K943732 LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE Graphic Controls Corp. HGP Class II 1994-10-20
K944129 IMAGYN LAPAROSCOPIC INSTRUMENTS Imagyn Medical, Inc. HET Class II 1994-10-20
K943598 FLEXIBLE FIBER OPTIC LAPAROSCOPES Optimed Technologies, Inc. HET Class II 1994-10-18
K930912 HYSTEROMED 100 Northgate Technologies, Inc. HIG Class II 1994-10-17
K941641 DISPOSABLE EMERGENCY OBSTETRICAL KIT Gam Industries, Inc. KNA Class II 1994-10-03
K933300 GEISTER SURGICAL INT'L MONOPOLAR ENDOSCOPIC SURG.INST. Lyle Howard Corp. KNF Class II 1994-09-30
K931478 ZEISS OPMI L STEREO-LAPAROSCOPE Carl Zeiss, Inc. HET Class II 1994-09-28
K925333 SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE Aspen Labs HGI Class II 1994-09-27
K932114 TUBAL LUMEN SUPPORT Cook Ob/Gyn HFJ Class II 1994-09-27
K936011 INVAMED REUSABLE LAPAROSCOPIC TROCAR SYSTEM Invamed, Inc. HET Class II 1994-09-21
K944055 FORCEPS, SURGICAL GYNECOLOGICAL Owens Precision Systems, Inc. HCZ Class II 1994-09-20
K926259 SURGIMAT W.O.M. World of Medicine GmbH HET Class II 1994-09-14
K931077 LATEX PROPHYLACTIC RUBBER CONTRACEPTIVE J.K. Chemicals, Ltd. HIS Class II 1994-09-14
K943989 LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT Gabris Surgical Corp. HFO Class II 1994-09-12
K923656 LIGHTING SOURCE SYSTEM Galenica Enterprises, Inc. HIC Class II 1994-09-08
K925560 ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES Zinnanti Surgical Instruments, Inc. HGI Class II 1994-08-30
K920747 PESSARY FLEXIBLE SILICONE DONUT RING Bioteque America, Inc. HHW Class II 1994-08-29
K933763 SAVE-T-BREATH AMBILICAL CORD CLAMP Save-T-Breath Distributors C.C. HFW Class II 1994-08-29
K926218 EISMAN-TRIES MEP (MULTIPLE ELECTRODE PROBE) Sandhill Scientific, Inc. HIR Class II 1994-08-26
K925079 LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER) Endo Technic Corp. HET Class II 1994-08-24
K936071 SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE Smith & Nephew Dyonics, Inc. HET Class II 1994-08-19
K935862 NORTHGATE TECHNOLOGIES OMNIFLATOR MODEL 6600 Northgate Technologies, Inc. HIF Class II 1994-08-19
K940518 C-SECTION TRAY Cush Medical Products MLS Class II 1994-08-18
K942887 MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM Hewlett-Packard Co. HGM Class II 1994-08-15
K934959 MODEL 118 FETAL/MATERNAL MONITOR Ge Medical Systems Information Technologies HGM Class II 1994-08-15
K942814 SELF SUPER MAXI SNAITARY NAPKINS Kegan & Kegan, Ltd. HHD Class I 1994-08-05
K941272 KLEENSPEC Welch Allyn, Inc. HIB Class II 1994-08-02
K941936 UNSCENTED MENSTRUAL TAMPON Johnson & Johnson Worldwide HEB Class II 1994-07-29
K930773 SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS Symbiosis Corp. HFB Class I 1994-07-28
K933153 PENTHOUSE CONDOMS Kuron Health Products Corp. HIS Class II 1994-07-28
K941044 PLAYTEX ULTIMATED TAMPONS MODEL NUMBER 06194 Playtex, Inc. HIL Class II 1994-07-27
K940681 CLEARVIEW UTERINE MANIPULATOR Clinical Innovations, Inc. LKF Class II 1994-07-26
K941944 TAHOE SURGICAL INSTRUMENTS LIGATURE DEVICE Tahoe Surgical Instruments P.R., Inc. HET Class II 1994-07-25
K930867 AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR United States Surgical, A Division of Tyco Healthc LKF Class II 1994-07-25
K923335 ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION Advanced Medical Systems, Inc. HGL Class II 1994-07-22
K940718 INNERVISION INC. LAPAROSCOPIC HAND INSTRUMENTS Innervision, Inc. HET Class II 1994-07-22
K935634 WALLACH LEEP PROCEDURE KIT Wallach Surgical Devices, Inc. HGI Class II 1994-07-20
K921294 VIDEO ENDOSCOPE-RIGID MODIFICATION Medical Dynamics, Inc. HET Class II 1994-07-20
K935820 KOLSTER METHODS Kolster Methods HGH Class II 1994-07-19
K934286 HYSTEROSCOPE Bei Medical Systems Co., Inc. HIH Class II 1994-07-19
K926597 LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) Optimed Technologies, Inc. HET Class II 1994-07-12
K942418 PLAYTEX TAMPONS MODEL 13794 Playtex, Inc. HEB Class II 1994-07-08
K932983 COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI) Sime Health, Ltd. HIS Class II 1994-07-07
K932982 SPERMICIDAL LUBRIC. CONDOMS (ESSENTIALS, MI VIDA, JIFFI) Sime Health, Ltd. HIS Class II 1994-07-07
K932984 UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFI Sime Health, Ltd. HIS Class II 1994-07-07
K924611 IRRIGATION PUMP AND TUBING SET Marlo Surgical Technology HET Class II 1994-06-30
K930954 THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV Cabot Medical Corp. HIB Class II 1994-06-30
K925478 ELECTROSURGICAL ELECTRODE Megadyne Medical Products, Inc. HGI Class II 1994-06-27
K941863 O.B. TAMPON Personal Products Co. HEB Class II 1994-06-27
K933768 COAGULATOR, LAPAROSCOPIC, LUNIPOLAR/ACCESSORIES Mahe-Medizintechnik HET Class II 1994-06-27
K911620 STOVALL ENDOMETRIAL BRUSH Cook Ob/Gyn HFE Class II 1994-06-24
K921942 HYSTEROSCOPE (AND ACCESSORIES) Optimed Technologies, Inc. HIH Class II 1994-06-24
K932115 ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI Blairden Precision Instruments, Inc. LKF Class II 1994-06-24
K930200 MULTI DOPPLEX II / FETAL DOPPLEX II Huntleigh Healthcare, Inc. KNG Class II 1994-06-24
K940505 ARTICULATING LAPAROSCOPIC RETRACOTOR (URESIL) Uresil Corp. HET Class II 1994-06-21
K941208 DIAGNOSTIC SLEEVE, REDUCER SLEEVE New Eder Corp. HET Class II 1994-06-17
K921732 MINOR LAP SET Medikmark, Inc. KOH Class I 1994-06-15
K921730 C-SECTION PACK Medikmark, Inc. KOH Class I 1994-06-15
K922323 MX4042/MC4044 SERIES SIMULCATH(TM) Medex, Inc. KXO Class II 1994-06-14
K941334 DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE Davol, Inc. HET Class II 1994-06-14
K922420 CONTINUOUS FLOW HYSTERO-RESECTOSCOPE Linvatec Corp. HIH Class II 1994-06-14
K926596 OWENS ENDOSCOPIC INSTRUMENTS AND ACCESSORIES Owens Industries, Inc. HET Class II 1994-06-10
K923260 LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT CURVED Imtec Corp. HET Class II 1994-06-09
K931764 HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES Olympus Corp. HIH Class II 1994-06-08
K925960 FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE Zinnanti Surgical Instruments, Inc. HFI Class II 1994-06-07
K925957 SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE Zinnanti Surgical Instruments, Inc. HFI Class II 1994-06-07
K926594 OWENS LAPAROSCOPY INSTRUMENTS AND ACCESSORIES Owens Industries, Inc. HET Class II 1994-06-06
K931541 MODEL 26-0375, ELECTROSURGICAL GENERATOR Cameron-Miller, Inc. HGI Class II 1994-06-01
K931814 DMI UTERINE MOBILIZER/ELEVATOR/CANNULA Diversified Medical Instruments, Inc. LKF Class II 1994-05-31
K942207 REFLEX INS INSUFFLATION NEEDLE Richard-Allan Medical HIF Class II 1994-05-27
K935434 OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT United States Surgical, A Division of Tyco Healthc LKF Class II 1994-05-27
K931437 MODEL 80-1983, ELECTROSURGICAL GENERATOR Cameron-Miller, Inc. HGI Class II 1994-05-27
K932035 NON-LINTING DELIVERY BLANKET Amsco Sterile Recoveries, Inc. KNC Class II 1994-05-26
K934928 INSITE FILTER & TUBING SET Andronic Devices, Ltd. HIF Class II 1994-05-26
K933767 FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY Mahe-Medizintechnik HFB Class I 1994-05-26
K941685 DISPOSABLE FILTERED INSUFFLATION TUBING SET Blue Planet Industries, Inc. HIF Class II 1994-05-26
K934926 INSITE MODEL 20 & MODEL 15 INSUFFLATORS Andronic Devices, Ltd. HIF Class II 1994-05-26
K940468 FEMININE MAXI PADS B.A. Wholesale, Inc. HHD Class I 1994-05-26
K926595 OWENS BIOPSY FORCEPS Owens Industries, Inc. HFB Class I 1994-05-25

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