meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
46
Latest Decision
1989-03-13

Clearances · page 38 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K883409 AEGIS(TM) CONDOMS Green Cross Medical Supplies Corp. HIS Class II 1989-03-13
K884402 EXTRA STRENGTH SKIN LESS SKIN CONDOM Okamoto USA, Inc. HIS Class II 1989-03-10
K885274 ROCKET ENDOCERVICAL BRUSH A & A Medical, Inc. HHT Class II 1989-03-09
K884868 OBSTETRICAL SAFETY SYSTEM Buckman Co., Inc. KNC Class II 1989-03-01
K884399 STANDARD LATEX CONDOM Schmid Laboratories, Inc. HIS Class II 1989-03-01
K885194 KOTEX SECURITY TUBE TAMPONS Kimberly-Clark Corp. HEB Class II 1989-03-01
K882080 MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS. Aequitron Medical, Inc. HFM Class II 1989-03-01
K890385 MIDWIFERY/OBSTETRICAL FORCEPS Kinetic Medical Products HDA Class II 1989-03-01
K871358 SENSATIONS BRAND CONDOMS Apex Medical Technologies, Inc. HIS Class II 1989-03-01
K890380 CERVICAL BIOPSY FORCEPS Kinetic Medical Products HFB Class I 1989-02-27
K890387 MALLEABLE PLACENTA CURETTE Kinetic Medical Products HEX Class II 1989-02-27
K890382 COMPRESSION FORCEPS Kinetic Medical Products HFW Class II 1989-02-27
K890376 VAGINAL SPECULUM Kinetic Medical Products HFD Class II 1989-02-27
K885061 SIEMENS INTRAVAGINAL TRANSDUCER Siemens Medical Solutions USA, Inc. HEM Class II 1989-02-23
K884934 JEDMED KP6 COLPOSCOPE Jedmed Instrument Co. HEX Class II 1989-02-23
K890383 HYSTERECTOMY FORCEPS Kinetic Medical Products HCZ Class II 1989-02-16
K890386 PLACENTA AND OVUM FORCEPS Kinetic Medical Products HCZ Class II 1989-02-13
K890379 UTERINE TENTACULUM Kinetic Medical Products HDC Class II 1989-02-13
K890388 CEPHALOTOMY SCISSORS Kinetic Medical Products KNB Class II 1989-02-13
K890389 UMBILICAL SCISSORS Kinetic Medical Products HDJ Class I 1989-02-13
K890384 UTERINE CURETTE Kinetic Medical Products HCY Class I 1989-02-13
K890378 UTERINE DRESSING FORCEPS Kinetic Medical Products HCZ Class II 1989-02-13
K890375 VAGINAL SPECULUM Kinetic Medical Products HDF Class I 1989-02-13
K890377 FIXED-SIZE UTERINE DILATOR Kinetic Medical Products HDQ Class I 1989-02-13
K884873 CERVICAL BRUSH Statlab Medical Products, Inc. HHT Class II 1989-02-09
K881384 INTERLABIAL PAD Xtramedics, Inc. HEB Class II 1989-02-09
K881857 AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU. Spectramed, Inc. KXO Class II 1989-02-01
K884696 RESUBMITTED ARTIFICIAL INSEMINATION INSTRUMENT SET Laboratoire Ccd C/O Washington Regulatory Services HDR Class II 1989-01-27
K884781 OPTI-POINT Plastic Injectors, Inc. HET Class II 1989-01-12
K884401 SKIN LESS SKIN CONDOM W/SPERMICIDAL LUBRICANT Okamoto USA, Inc. HIS Class II 1989-01-12
K884685 ROCKET FETAL BLOOD SAMPLING TRAY A & A Medical, Inc. HGW Class II 1989-01-12
K884950 TAMPAX ULTRAFIT PANTY SHIELDS Tambrands, Inc. HHD Class I 1989-01-10
K884737 PLAYTEX NON-DEODORANT AND DEODORANT TAMPONS Playtex Family Products, Inc. HIL Class II 1989-01-10
K884951 TAMPAX ULTRAFIT PANTY SHIELDS, DEODORANT Tambrands, Inc. HHL Class II 1989-01-10
K884305 KOTEX STICK TAMPONS, REGULAR AND SUPER Kimberly-Clark Corp. HEB Class II 1988-12-20
K884446 MAXITHINS SUPER PADS, DEODORANT Tambrands, Inc. HHL Class II 1988-12-20
K880587 AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH MEDIUM #3 C.I.S.A. Import Export C/O Larson and Taylor HIB Class II 1988-12-20
K880586 AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH SMALL #2 C.I.S.A. Import Export C/O Larson and Taylor HIB Class II 1988-12-20
K880588 AUTOEXPANDABLE SPECULUM MODEL LEIBOVIC LARGE #4 C.I.S.A. Import Export C/O Larson and Taylor HIB Class II 1988-12-20
K884684 ROCKET INTRAUTERINE DEPTH SOUND A & A Medical, Inc. HHM Class I 1988-12-20
K883334 BIODOP(TM) Diagnosis Related Systems, Inc. HEK Class II 1988-12-15
K883832 CATHETER, INTRAUTERINE AND INTRODUCER Telos Medical Corp. KXO Class II 1988-12-13
K884291 COOK HYSTEROCATH(TM) Cook, Inc. KNA Class II 1988-12-08
K884290 BAXTER DISPOSABLE CIRCUMCISION TRAY Baxter Healthcare Corp HFX Class II 1988-12-08
K883413 TROJAN EXTRA STRENGTH LUBRICATED Carter Products HIS Class II 1988-12-08
K884444 MAXITHINS REGULAR PADS, DEODORANT Tambrands, Inc. HHL Class II 1988-12-05
K884445 MAXITHINS PANTY SHIELDS, DEODORANT Tambrands, Inc. HHL Class II 1988-12-05
K884428 ALWAYS UNSCENTED MENSTRUAL PADS Procter & Gamble Co. HHD Class I 1988-12-02
K884429 ALWAYS SCENTED OR SCENTED DEODORIZED MENSTRUAL PAD Procter & Gamble Co. HHL Class II 1988-12-02
K883867 CERVICAL BIOPSY INSTRUMENT Mend Technologies, Inc. HEB Class II 1988-11-29
K883806 ROCKET INTRAUTERINE SOUND A & A Medical, Inc. HHM Class I 1988-10-31
K882893 CONDOMS (RAMSES, SHEIK AND KOROMEX) Schmid Laboratories, Inc. HIS Class II 1988-10-26
K883467 THE SAXON SPERMICIDAL CONDOM Circle Rubber Corp. HIS Class II 1988-10-26
K882389 KISS OF MINT(TM) NON-LUBRICATED CONDOM Ansell, Inc. HIS Class II 1988-10-20
K883283 DISPOSABLE AMNIOTOME Galenica Enterprises, Inc. HGG Class II 1988-10-18
K881456 PIPELLE DE CORNIER ENDOMETRIAL SUCTION CURETTE Laboratoire Ccd C/O Washington Regulatory Services HHK Class II 1988-10-14
K884042 ROCKET CERVICAL SPATULA A & A Medical, Inc. HHT Class II 1988-10-07
K882966 MODEL 320 FETAL/MATERNAL TELEMETRY SYSTEM Ge Medical Systems Information Technologies HGM Class II 1988-10-05
K883721 FEMALE CONTINENCE DEVICE Cook Ob/Gyn HHW Class II 1988-10-03
K882054 HYSTERO KIT Zinnanti Surgical Instruments, Inc. HDP Class II 1988-09-29
K882094 GARDS DEODORANT SANITARY NAPKIN Hospital Specialty Co. HHL Class II 1988-09-22
K882009 KING KONDOM (CONDOM) King Kondom Products, Inc. HIS Class II 1988-09-21
K882761 TRANSERVICAL ENDOSCOPE (HYSTEROSCOPE) Intramed Laboratories, Inc. HIH Class II 1988-09-20
K882605 EURO-MED CLEAR-VUE DISPOSABLE VAGINAL SPECULUM Buckman Co., Inc. HIB Class II 1988-09-15
K880314 HYSTEROSCOPE AUTONOM 4992 Richard Wolf Medical Instruments Corp. HIH Class II 1988-08-25
K871875 MODEL 5050 SURGILASER FOR OB-GYN USE Lasermatic, Inc. HHR Class II 1988-08-22
K881295 LAMINARIA CUREX Harold W. Berger Co. HDY Class II 1988-08-10
K882768 LAURIER SANITARY NAPKIN Kao Corp. HHD Class I 1988-08-05
K875314 GL-35 COLPOSCOPIC LASER SYSTEM Laser Engineering, Inc. HHR Class II 1988-08-05
K881405 SIEMENS INTRAVAGINAL TRANSDUCER Siemens Medical Solutions USA, Inc. HGL Class II 1988-08-02
K882364 KOTEX LIGHTDAYS LONGS DEODORANT & REG. PANTILINERS Kimberly-Clark Corp. HHD Class I 1988-08-02
K881249 BAGGISH, HYSTEROSCOPE Bryan Corp. HIH Class II 1988-07-28
K882109 DISPOSEABLE MENSTRUAL PANTY Glamor Plus Co. HHD Class I 1988-07-26
K882606 EURO-MED ENDO-CURETTE Buckman Co., Inc. PCF Class II 1988-07-25
K882628 ENDO C BRUSH Milex Products, Inc. HHT Class II 1988-07-25
K881921 C-E BRUSH Surgipath Medical Industries, Inc. HHT Class II 1988-07-19
K881680 ACKRAD H/S PROCEDURE TRAY Ackrad Laboratories HIG Class II 1988-07-15
K882404 KEVOR-CURETTE Euro-Med Intl. PCF Class II 1988-07-08
K881794 IVORY FINDER SET Ivory Instruments Co. HCY Class I 1988-07-08
K881100 CONDOM Glnic Corp. HIS Class II 1988-07-08
K881735 CONDOM Iris Medical Ent., Inc. HIS Class II 1988-07-05
K874236 APOLLO CONDOM Apollo Enterprise, Ltd. Co. HIS Class II 1988-07-01
K880919 (CHOICE) ALSO (KONDUM) Select Sources, Inc. HIS Class II 1988-06-29
K880189 NEW JELLIACOAT K&G Import/Export Co. HIS Class II 1988-06-27
K874615 LASER CANNISTER FILTER Medical Marketing, Inc. HHR Class II 1988-06-23
K874612 TITANIUM RODS Medical Marketing, Inc. HET Class II 1988-06-23
K874611 TITANIUM BACKSTOP WITH SUCTION Medical Marketing, Inc. HET Class II 1988-06-23
K874614 SUCTION AND LAVAGE PROBE Medical Marketing, Inc. HET Class II 1988-06-23
K882185 ELECTRONIC INSUFFLATOR, MODEL NO. 2054.60 Richard Wolf Medical Instruments Corp. HIF Class II 1988-06-22
K875123 ORCEPAD Alton Dean Medical, Inc. HDD Class II 1988-06-21
K880820 OKAMOTO CONDOMS SPERMICIDALLY LUBRICATED Schmid Laboratories, Inc. HIS Class II 1988-06-21
K880185 DUET (CONDOMS) American Laboratories, Inc. HIS Class II 1988-06-17
K881414 CERVICATH Epcom Medical Systems, Inc. HDR Class II 1988-06-14
K881220 ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER Laboratoire Ccd C/O Washington Regulatory Services HFE Class II 1988-06-14
K881967 CMI VACUUM PUMP #001C - VACUUM PUMP (NON-ELECTRI.) Challenge Mfg., Inc. HDB Class II 1988-06-13
K880463 CONDOM (PROPHYLACTIC) Health Technologies Intl. HIS Class II 1988-06-13
K881306 CMI VACUUM DELIVERY SYSTEM #003C AND #004C Challenge Mfg., Inc. HDB Class II 1988-06-13
K880419 MODEL 800 O.B. DATA ARCHIVAL SYSTEM Ge Medical Systems Information Technologies HGM Class II 1988-06-10
K881216 GENT-L-KARE VAGINAL IRRIGATION SET Geneva Laboratories, Inc. HED Class I 1988-06-07
K881185 ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA. Philips Medical Systems (Cleveland), Inc. HEM Class II 1988-06-01

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