meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
38
Latest Decision
1991-08-14

Clearances · page 34 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K911326 OBSTETRICAL VACUUM CUP Gesco Intl., Inc. HDB Class II 1991-08-14
K912002 PLAYTEX NON-DEODORANT/DEODORANT TAMPONS Playtex Family Products, Inc. HIL Class II 1991-08-12
K911887 MAJOLI UTERINE MANIPULATOR/INJECTOR Cook Ob/Gyn LKF Class II 1991-07-26
K911190 PERRYMETER(TM) Perrymeter Systems HIR Class II 1991-07-26
K910169 FETALGARD 2000 Analogic Corp. HGM Class II 1991-07-22
K910418 LIFE-TRACE DISPOSABLE LEG PLATE PRODUCT # LT-100 Graphic Controls Corp. HGM Class II 1991-07-16
K911657 FETAL SCALP SPIRAL ELECTRODE Advanced Medical Systems, Inc. HGP Class II 1991-07-11
K911474 LAPAROSCOPIC FORCEPS United States Endoscopy Group, Inc. HCZ Class II 1991-07-03
K911272 ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705 Edward Weck, Inc. FHG Class II 1991-07-02
K904600 L582 TRANSDUCER Acuson Corp. MAA Class II 1991-06-24
K912044 MODEL 700 LAPAROSCOPIC ELECTRONIC INSUFFLATOR Multigon Industries, Inc. HIF Class II 1991-06-24
K904583 SONO-VU US(TM) E-Z-Em, Inc. HIO Class I 1991-06-24
K910462 POCKET DOP 3 Imex Medical Systems, Inc. HEP Class II 1991-06-24
K911453 OBTRASOUND STETHOSCOPE FETAL CALC Medasonics, Inc. KNG Class II 1991-06-20
K905563 INTRAN PLUS Utah Medical Products, Inc. KXO Class II 1991-06-19
K911699 STI TISSUE MANIPULATOR Surgical Technologies, Inc. HIN Class II 1991-06-13
K910426 SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT Shimadzu Medical Systems HEM Class II 1991-06-06
K910284 CONDOMS (RUBBER CONTRACEPTIVES) Suretex, Ltd. HIS Class II 1991-06-04
K910550 CONDOMS/SAXON, GOLD CIRCLE COIN, EMBRACE & RAINBOW Safetex Corp. HIS Class II 1991-06-03
K905456 L328 TRANSDUCER Acuson Corp. MAA Class II 1991-05-28
K911327 CELL SWEEP Reza S Mohajer, M.D. C/O Krass & Young HHT Class II 1991-05-21
K910907 PUMP VAC PLUS Marlo Surgical Technology HET Class II 1991-05-13
K910518 GLOVE-N-GEL AMNIOTOMY KIT Epcom Medical Systems, Inc. HGE Class I 1991-05-09
K910577 EDWARDS-WALLACE BOURNE HALL CATHETER Marlo Surgical Technology MFD Class II 1991-05-09
K905471 TROCAR ACCESS SHEATH Cook Ob/Gyn HET Class II 1991-05-09
K910788 CMI TENDER TOUCH VE #303TT AND 404TT Challenge Mfg., Inc. HIS Class II 1991-05-09
K910317 UNI-SEM(TM) Unimar, Inc. MFD Class II 1991-05-01
K905392 HT4-SERIES HYSTEROSCOPES AND ACCESSORIES Frigitronics, Inc. HIH Class II 1991-04-30
K905495 HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR Frigitronics, Inc. HIG Class II 1991-04-29
K904951 S5192R TRANSDUCER Acuson Corp. MAA Class II 1991-04-29
K910209 LAPAROSCOPIC IRRIGATOR/ASPIRATOR Solos Mfg. HET Class II 1991-04-29
K911479 LAPAROSCOPIC INSUFLATION Y TUBING United States Endoscopy Group, Inc. HIF Class II 1991-04-29
K910253 LEEP REDIKIT CooperSurgical, Inc. HEE Class II 1991-04-18
K910254 DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM) CooperSurgical, Inc. HHE Class II 1991-04-18
K905583 ILC FORCEPS PADS Inman Liebelt Corp. HDA Class II 1991-04-12
K904848 PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND SLEEVE Origin Medsystems, Inc. HET Class II 1991-04-08
K903002 PROBET (TM) Gynopharma, Inc. HFF Class II 1991-04-05
K910227 MX4043---SERIES, INTRAUTERINE PRESSURE CATHETER Medex, Inc. KXO Class II 1991-04-03
K910578 MCLAUGHLIN LAPAROSCOPIC GRASPER Marlo Surgical Technology HIS Class II 1991-04-03
K910015 CANNULA INTRODUCTION SET Lazarus Medical, Inc. HET Class II 1991-04-02
K902305 TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM. Armkel, LLC HIS Class II 1991-03-29
K910282 MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER Graphic Controls Corp. HFM Class II 1991-03-29
K902324 TP AND DESIGN, CONDOM China National Medicines & Health Prod. I/E Corp. HIS Class II 1991-03-29
K910153 UST-974-5 CONVEX TRANSDUCER Ge Medical Systems Information Technologies KNG Class II 1991-03-29
K910883 LAPAROFLATOR ELECTRONIC 3509 F.M. Wiest USA, Inc. HIF Class II 1991-03-29
K905830 COMBO FETAL SCALP ELECTRODE/LEGPLATE Utah Medical Products, Inc. HGP Class II 1991-03-29
K905481 NORTHGATE TECHNOLOGIES MODEL 7201 INSUFFLATOR Northgate Technologies, Inc. HIF Class II 1991-03-29
K910713 FLYNN TISSUE PROBE AND BLUNT DISSECTOR Marlo Surgical Technology HET Class II 1991-03-21
K910008 ENDOTHRED ADJUSTABLE STABILITLY THEREAD ETHICON, Inc. HET Class II 1991-03-21
K910260 COROMETRICS MDL 330 FETAL/MATERNAL TELEMETRY SYST Ge Medical Systems Information Technologies HGM Class II 1991-03-15
K904937 PLAYTEX ULTIMATES UNSCENTED AND SCENTED TAMPONS Playtex Family Products, Inc. HEB Class II 1991-03-15
K905606 EXTERNAL FETAL MONITOR TRANSDUCER HOLDER Atheus Corp. HGM Class II 1991-03-12
K905764 SEMINOR Promedex, Inc. MFD Class II 1991-03-12
K905759 HASSON STABILIZING ACCESS CANNULA FOR OPEN LAPAROS Marlo Surgical Technology HET Class II 1991-03-06
K902936 POLYURETHANE CONDOM Apex Medical Technologies, Inc. HIS Class II 1991-03-06
K903339 VIDEO ENDOSCOPE, RIGID Medical Dynamics, Inc. HET Class II 1991-03-06
K902197 FUJINON EVL-F (TENTATIVE) AND TROCAR Fujinon, Inc. HET Class II 1991-03-05
K905178 DELUXE SANITARY PAD American Healthcare Corp. HHD Class I 1991-03-04
K905196 LAPAROSCOPE Baxter Healthcare Corp HET Class II 1991-03-04
K910252 POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE CooperSurgical, Inc. HEE Class II 1991-03-04
K910579 OVARIAN ASPIRATION/IRRIGATION NEEDLE Marlo Surgical Technology HET Class II 1991-02-28
K905705 LAP 3501 HIGH FLOW INSUFFLATOR Circon Acmi HIF Class II 1991-02-28
K905706 GYN-1500 HYSTEROSCOPIC INUFFLATOR Circon Acmi HIG Class II 1991-02-28
K910287 OTT CERVICAL TENACULUM Marlo Surgical Technology HDC Class II 1991-02-28
K904645 HALL TRANSCEERVICAL SAFE ACCESS CANNULA(TM) Hall Medical Laboratories HET Class II 1991-02-26
K910340 LAPAROSCOPIC ASPIRATION PROBE Davol, Inc. HET Class II 1991-02-26
K904000 TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR Armkel, LLC HIS Class II 1991-02-19
K905295 CATALOG NUMBER 2609 LEG PLATE Ge Medical Systems Information Technologies HGM Class II 1991-02-19
K904240 SINGLE USE LAPARSCOPIC ELECTRODE Aspen Labs HFG Class II 1991-02-19
K905549 THE DART Dexide, Inc. HIF Class II 1991-02-19
K904691 AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST Air-Shields Vickers, Inc. HFM Class II 1991-02-19
K905279 CONDOM (RUBBER) CONTRACEPTIVE Aladan Corp. HIS Class II 1991-02-19
K905854 CONDOMS Barnetts, Inc. HIS Class II 1991-02-15
K905115 BIOVISION ENDOCULAR PROBE Douglas James Donaldson Compliance Services HGF Class II 1991-02-11
K905426 AUTO SUTURE MODIFIED ENDO STREAM SUC./IRRI. DEVICE United States Surgical, A Division of Tyco Healthc HET Class II 1991-02-11
K905378 PLAYTEX NON-DEODORANT AND DEODORANT TAMPONS Playtex Family Products, Inc. HIL Class II 1991-02-11
K904079 BARD UTERINE MANIPULATOR C.R. Bard, Inc. LKF Class II 1991-02-07
K902690 SONICAID MODEL MERIDIAN 800 Oxford Medilog, Inc. HGM Class II 1991-02-05
K905000 ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER Corometrics Medical Systems, Inc. HEM Class II 1991-01-31
K905417 ELMED PNEUMOMAT DIGITAL Elmed, Inc. HIF Class II 1991-01-31
K902995 PC-BEADS POSTCOITAL TEST Microscopy Research Innovations HHT Class II 1991-01-31
K905812 INTRAUTERINE CATHETER SET Epcom Medical Systems, Inc. HGS Class II 1991-01-31
K903989 SIL-MED T-TUBE DRAIN Sil-Med Corp. HFL Class II 1991-01-31
K902693 WALLACH FLEXIBLE ENDOMETRIAL SAMPLER Wallach Surgical Devices, Inc. HFF Class II 1991-01-31
K904745 MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE Graphic Controls Corp. HGP Class II 1991-01-29
K905130 FETAL MONITORING SPIRAL ELECTRODE Graphic Controls Corp. HGP Class II 1991-01-29
K904907 ENDOPATH DISPOSABLE SURGICAL TROCAR REDUCER ETHICON, Inc. HET Class II 1991-01-24
K904379 SURGICAL TROCAR AND CANNULA Applied Vascular Devices, Inc. HET Class II 1990-12-21
K902907 MAMBA CONDOM (RUBBER LATEX) Rfsu HIS Class II 1990-12-21
K903209 MAXI-FLOW INSUFFLATOR TUBING SET W/FILTER Adler Instrument Co. HES Class II 1990-12-21
K896098 GUARDIAN & JANITEX CONDOM/PROPHYLACTIC Allied Rubber Industries Sdn. Bhd. HIS Class II 1990-12-19
K903992 CYGNET CENTRAL Cygnet Co., Inc. HGM Class II 1990-12-19
K903208 MAXI-FLOW INSUFFLATOR TUBING SET Adler Instrument Co. HES Class II 1990-12-17
K903078 HASSON STABILIZING ACCESS CANNULA Marlo Surgical Technology HET Class II 1990-12-17
K904248 MODEL GLASE 210 HOLMIUM LASER SYSTEM Charles L. Rose and Co., Inc. HGF Class II 1990-12-14
K904473 KRONNER MANIPUJECTOR Unimar, Inc. HES Class II 1990-12-14
K904173 INSULATED ELECTRODES AND LAPAROSCOPIC PROBICS Baxter Healthcare Corp HET Class II 1990-12-10
K904774 INGLAT-O-BALL Milex Products, Inc. HHW Class II 1990-12-07
K900404 VARICOSCREEN(TM) Promedex, Inc. KYA Class I 1990-12-07
K904143 V. MUELLER TROCARS/TROCAR SLEEVES & NEEDLES Baxter Healthcare Corp HET Class II 1990-12-06

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