meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
28
Latest Decision
1995-06-13

Clearances · page 29 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K951490 LASEVAC D.D. Surgical, Inc. HET Class II 1995-06-13
K951148 OBSTI-HOOK Onli HGE Class I 1995-06-09
K942563 ELITE BIOFEEDBACK Laborie Medical Technologies, Ltd. HIR Class II 1995-06-06
K945841 BIRTH THEFT INFANT IDENTIFICATION AND PROTECTION UMBILICAL CORD CLAMP W G M Corp. HFW Class II 1995-05-30
K951140 KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR Balagan Medical, Inc. HFW Class II 1995-05-25
K943662 LAPARASCOPE Pollux Endoscopy, Inc. HET Class II 1995-05-25
K946147 KSE STEINER ELECTROMECHANIC MORCELLATOR KARL STORZ Endoscopy-America, Inc. HET Class II 1995-05-25
K942534 GERBER NATURAL COMFORT BATTERY BREAST PUMP Gerber Products Co. HGX Class II 1995-05-25
K950708 LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000 Graphic Controls Corp. KXO Class II 1995-05-25
K950961 KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP KARL STORZ Endoscopy-America, Inc. HIG Class II 1995-05-25
K942858 LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9) Suretex, Ltd. HIS Class II 1995-05-18
K945131 IMAGYN INTRAUTERINE INSEMINATION DEVICE Imagyn Medical, Inc. HDR Class II 1995-05-15
K950420 FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3 Analogic Corp. HGM Class II 1995-05-15
K932149 THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE Thought Technology , Ltd. HIR Class II 1995-05-11
K950714 COOK INSEMINATION CUP Cook Urological, Inc. HDR Class II 1995-05-11
K941438 OP-PNEU ELECTRONIC CO2 Wisap/U.S.A. HIF Class II 1995-05-11
K950108 R-MED MINI-RETRACTOR R-Med, Inc. HET Class II 1995-05-11
K951528 AMSINO DISPOSABLE VIGINAL SPECULUM Amsino Intl., Inc. HIB Class II 1995-05-11
K924312 NURTURE III Bailey Medical Engineering HGX Class II 1995-05-11
K935213 INCONTROL Thought Technology , Ltd. HIR Class II 1995-05-11
K946359 KARL STORZ DILATION SET, REDUCERS, THREAD SLEEVES, DISTANCE HOLDERS KARL STORZ Endoscopy-America, Inc. HET Class II 1995-05-11
K950457 CANNUAL AND TROCAR, SUPERPUBIC Core Dynamics, Inc. HET Class II 1995-05-05
K945685 KARL STORZ TELESCOPE BRIDGES AND INSERTS, ADAPTERS KARL STORZ Endoscopy-America, Inc. HET Class II 1995-05-05
K942725 CMI VELVET TOUCH VACUUM EXTRACTOR Columbia Medical & Surgical, Inc. HDB Class II 1995-05-05
K922688 EXTRA PROTECTION POLYURETHANE CONDOM Apex Medical Technologies, Inc. MOL Class II 1995-05-04
K933654 BLADDER NECK SUPPORT PROTHESIS FITTING KIT Johnson & Johnson Medical, Inc. HHW Class II 1995-05-04
K921791 WALLACH LEAP 100 ELECTRO SURGERY SYSTEM Wallach Surgical Devices, Inc. HGI Class II 1995-05-04
K930618 VAGINAL CONTINENCE DEVICE Johnson & Johnson Medical, Inc. HHW Class II 1995-05-04
K943938 MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE Neward Enterprises, Inc. HDB Class II 1995-05-03
K951393 ABACUS OB ULTRASOUNG COMPUTER SOFTWARE Solomon Technology Labs HEM Class II 1995-05-01
K933544 FUJINON VIDEO LAPORASCOPE Fujinon, Inc. HIH Class II 1995-04-27
K940094 COLPOSCOPES AND ACCESSORIES Leisegang Medical, Inc. HEX Class II 1995-04-25
K942730 AESCULAP LAPAROSCOPES Aesculap, Inc. HET Class II 1995-04-25
K941743 CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP Cabot Medical Corp. HIG Class II 1995-04-19
K943883 SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM Aladan Corp. HIS Class II 1995-04-14
K930013 CO2 INSUFFLATOR 1100 Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz HIF Class II 1995-04-14
K924523 HYS-SURGIFLATOR W.O.M. World of Medicine GmbH HIG Class II 1995-04-11
K943448 LUMIN Utah Medical Products, Inc. LKF Class II 1995-04-11
K942411 R-MED DISPOSABLE PLUG R-Med, Inc. HET Class II 1995-03-31
K945211 KARL STORZ RETRACTORE, PROBES, DISSECTORS, HOOKS, UTERINEELEVATORS, UTERINE CANNULAE KARL STORZ Endoscopy-America, Inc. HET Class II 1995-03-30
K943603 AESCULAP LAPAROSCOPIC ANCILLARY DEVICES Aesculap, Inc. HET Class II 1995-03-29
K931133 CLINICAL INFOR SYST(CIS) W/FETAL MONIT REMOTE DISP Clinicomp, Inc. HGM Class II 1995-03-29
K950219 ENDOLAP INSUFFLATOR TUBING SET Endolap, Inc. HIF Class II 1995-03-23
K950928 ULTIMATES SILK GLIDE TAMPONS Playtime Products, Inc. HIL Class II 1995-03-22
K942986 ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP) Aaron Medical Industries HGI Class II 1995-03-21
K943053 KSEA SEMM TISSUR PUNCH Karl Storz Endoskop GmbH HET Class II 1995-03-21
K932779 BIRTCHER SWIVEL GRIP LAPAROSCOPIC PROBES & ACCESS. Birtcher Medical Systems, Inc. HET Class II 1995-03-21
K945982 KARL STORZ TAKE-APART(R) SUTURE FORCEPS, KNOT TIER KARL STORZ Endoscopy-America, Inc. HET Class II 1995-03-21
K950232 LAPAROSCOPE AND ACCESSORIES FOR OB/GYN Olympus America, Inc. HET Class II 1995-03-16
K934115 3000 ELECTRONIC INSUFFLATOR MODIFICATION Cabot Medical Corp. HIF Class II 1995-03-15
K932387 CONCEPTUS VARI-SOFT CATH/PIROUETTE POSIT MANDREL Conceptus, Inc. HET Class II 1995-03-06
K941507 THEMO-FLO SYSTEM 3 LAPAROSCOPIC/HYSTEROSCOPIC SYSTEM Sanese Medical Corp. HET Class II 1995-03-06
K940898 MODEL IM77 INTRAPARTUM FETAL MONITOR Advanced Medical Systems, Inc. HGM Class II 1995-03-01
K941472 CERVEX-BRUSH PAP KIT Rovers Diagnostic Devices HHT Class II 1995-02-28
K945741 TROCAR AND CANNULA ACCESSORY Applied Medical Resources HET Class II 1995-02-28
K932276 CO2 HYDROMAT PUMP FOR IRRIGATION, MODEL #26310020 KARL STORZ Endoscopy-America, Inc. HET Class II 1995-02-28
K942973 HASSON STABILIZING ACCESS CANNULA (SAC) Entec Corp. HET Class II 1995-02-27
K950055 A4722 OLYMPUS OPTICAL OBTURATOR Olympus America, Inc. HIH Class II 1995-02-21
K942490 BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND Medical Soft, Inc. HEM Class II 1995-02-15
K946235 CONMED 7/8MM GASKET REDUCER FOR USE WITH TROGARD(TM) TROCAR SLEEVE Conmedcorp HET Class II 1995-02-13
K941298 IUMC ENDOMETRIAL SAMPLER Cook Ob/Gyn HFE Class II 1995-02-13
K944155 PLAYTEX ULTIMATES SILK GLIDE TAMPONS #23094 Playtex Products, Inc. HEB Class II 1995-02-09
K944064 PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22894 Playtex, Inc. HEB Class II 1995-02-09
K944154 PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22994 Playtex Products, Inc. HEB Class II 1995-02-09
K950036 OLYMPUS 5FR SEMI-RIGID SCISSORS FOR OB/GYN Olympus America, Inc. HIH Class II 1995-02-09
K944862 KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES KARL STORZ Endoscopy-America, Inc. KNF Class II 1995-02-09
K945789 DEROYAL DISPOSABLE INSUFFLATION TUBING FILTER Deroyal Industries, Inc. HIF Class II 1995-02-07
K934884 MODEL 2231 CO2 INSUFFLATOR Richard Wolf Medical Instruments Corp. HIF Class II 1995-02-07
K944509 DEXIDE INSUFFLATION TUBING WITH FILTER Dexide, Inc. HIF Class II 1995-02-07
K941112 SINGLE HANDED BREAST PUMP Macneil Baby Care , Ltd. HGX Class II 1995-01-30
K940046 NON-LUBRICATED CONDOM Ansell, Inc. HIS Class II 1995-01-30
K931122 OVAMED HSG CATHETER Ovamed Corp. LKF Class II 1995-01-30
K940045 CONDOM Ansell, Inc. HIS Class II 1995-01-30
K944268 CIT TWO WAY SUCTIN AND IRRIGATION TUBES Chirurgische Instrumente HET Class II 1995-01-26
K943810 IMAGYN MICROLAP INTRODUCER Imagyn Medical, Inc. HET Class II 1995-01-26
K932394 BERNSTEIN(TM) UTERINE MANIPULATOR Gm Engineering, Inc. LKF Class II 1995-01-26
K945179 BOTTLE COLLECTION SET Medgyn Products, Inc. HGF Class II 1995-01-26
K941458 UTERINE MANIPULATOR/INJECTOR WITH SPRING Zinnanti Surgical Instruments, Inc. LKF Class II 1995-01-25
K944269 CIT GRASPING AND DISSECTING FORCEPS Chirurgische Instrumente HET Class II 1995-01-24
K945100 KARL STORZ SUCTION/IRRIGATION TUBES, CANNULAE KARL STORZ Endoscopy-America, Inc. HET Class II 1995-01-24
K944793 KARL STORZ MONOPOLAR COAGULATION, NEEDLE, LOOP ELECTRODES KARL STORZ Endoscopy-America, Inc. KNF Class II 1995-01-24
K941207 MONOPOLAR SUCTION CANNULA; MONOPOLAR ELECTRODES New Eder Corp. KNF Class II 1995-01-24
K941457 UTERINE INJECTOR WITH SPRING Zinnanti Surgical Instruments, Inc. LKF Class II 1995-01-24
K936231 THE KARL STORZ HAMOU ENDOMAT Karl Storz Endoscopy HIG Class II 1995-01-24
K944079 IMAGYN MICROLAP(TM) LAPAROSCOPE Imagyn Medical, Inc. HET Class II 1995-01-20
K936273 STEREO OPSIS CAMERA SYSTEM 3-D DISTAL CAM AND 3-D DISTAL CAM 360 Baxter Healthcare Corp HET Class II 1995-01-06
K932993 INTRAUTERINE CATHETER AND INTRODUCER Conceptus, Inc. MFD Class II 1995-01-06
K933870 VIBA-BRUSH Rovers B.V. HHT Class II 1995-01-05
K935023 GODAT UTERINE MANIPULATOR INJECTOR Ideas For Medicine, Inc. LKF Class II 1995-01-04
K941831 LUBRICATING JELLY Barre-National, Inc. HIS Class II 1995-01-03
K940191 ELECTROSURGICAL LOOP ELECTRODE National Wire & Stamping, Inc. HGI Class II 1994-12-30
K934732 PELVIC EXAM TRAY Medcare Custom Packaging, Inc. HHT Class II 1994-12-30
K944555 ENDOSCOPE United States Surgical, A Division of Tyco Healthc HET Class II 1994-12-30
K933384 BARD HYSTERO-FLO II PUMP Davol Inc., Sub. C. R. Bard, Inc. HIG Class II 1994-12-30
K940907 MADDEN SURGICAL THIMBLE Kelley-Gilmer Medical Corp. KNA Class II 1994-12-29
K940091 INNOVA VAGINAL EMG SENSING ELECTRODE Empi HIR Class II 1994-12-29
K933873 CONCEPT UNIVERSAL PUMP SYSTEM Linvatec Corp. HIG Class II 1994-12-29
K933981 CERVICAL CATHETER Conceptus, Inc. LKF Class II 1994-12-27
K944563 FAMILY OF PRIMUS FORCEPS: GRASPERS/DISSECTORS/SUTURERS/NEEDLE DRIVERS Marlow Surgical Technologies, Inc. HET Class II 1994-12-27
K911431 TACTYLON(TM) CONDOM Tactyl Technologies, Inc. HIS Class II 1994-12-27

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