meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
28
Latest Decision
2000-06-20

Clearances · page 22 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K993625 INSUFFLATION NEEDLE- 120MM, MODEL 900-200 Genicon, LC HIF Class II 2000-06-20
K991334 MEDI-CULT HYALURONIDASE; Medicult A/S MQL Class II 2000-06-20
K991331 MEDI-CULT M3 MEDIUM Medicult A/S MQL Class II 2000-06-20
K000433 PBN HYSTERO-SALPINGOGRAPHY CATHETER SET Medical Device Technologies, Inc. LKF Class II 2000-06-16
K001545 PIPET CURET Milex Products, Inc. HHK Class II 2000-06-15
K001068 NBS CONNECTING TUBE SET Nbs Products CO HIF Class II 2000-06-14
K000627 SCANDINAVIAN IVF SCIENCES AB, HYBASE-1 Vitrolife AB/Scandinavian Ivf Sciences AB MQL Class II 2000-06-13
K001113 IVC THREE BLASTOCYST MEDIUM, CAT # 2007 Invitrocare, Inc. MQL Class II 2000-06-13
K993653 MICRO-FRANCE TROCARS AND ACCESSORIES Xomed, Inc. HET Class II 2000-06-09
K001377 SPERMICIDAL LUBRICATED MALE LATEX CONDOM Pleasure Latex Products Sdn. Bhd. LTZ Class II 2000-06-08
K001261 L720 EXAMINATION CHAIR Luneau Gynecologie SA KNC Class II 2000-06-08
K000989 SPERM WASH MEDIUM, CAT# 2003/2005 Invitrocare, Inc. MQL Class II 2000-06-08
K000673 HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241 Richard Wolf Medical Instruments Corp. HIH Class II 2000-05-26
K000937 IVC TWO MEDIUM Invitrocare, Inc. MQL Class II 2000-05-25
K993777 DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES R-Group Intl. HGI Class II 2000-05-25
K000938 IVC ONE MEDIUM Invitrocare, Inc. MQL Class II 2000-05-25
K993484 Q-HTF, CAT# 2001 Invitrocare, Inc. MQL Class II 2000-05-25
K000626 SCANDINAVIAN IVF SCIENCES AB, GAMETE-100 Vitrolife AB/Scandinavian Ivf Sciences AB MQL Class II 2000-05-23
K000974 FOWLER ENDOCURETTE, MODEL CUR-XXX Utah Medical Products, Inc. HHK Class II 2000-05-23
K000625 SCANDINAVIAN IVF SCIENCES AB, G1.2 Vitrolife AB/Scandinavian Ivf Sciences AB MQL Class II 2000-05-23
K001221 MALE LATEX COMDOM WITH DOTTED SURFACE Pleasure Latex Products Sdn. Bhd. HIS Class II 2000-05-19
K001119 ROVERS ENDOCERVEX-BRUSH Rovers Medical Devices B.V. HHT Class II 2000-05-19
K991348 IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500 Vitrolife Sweden AB MQL Class II 2000-05-17
K001115 ULTRA CATHETER SET Lyco Enterprises, Inc. LKF Class II 2000-05-17
K000618 SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1 Vitrolife AB/Scandinavian Ivf Sciences AB MQL Class II 2000-05-17
K993699 THE STRIPPER Mid-Atlantic Diagnostics, Inc. MQH Class II 2000-05-16
K000623 SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1 Vitrolife AB/Scandinavian Ivf Sciences AB MQL Class II 2000-05-16
K001220 ENDOPATH SURESEAL REDUCER CAP Ethicon Endo-Surgery, Inc. HET Class II 2000-05-16
K000621 SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100 Vitrolife AB/Scandinavian Ivf Sciences AB MQL Class II 2000-05-16
K000915 PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75 Humagen Fertility Diagnostics, Inc. MQK Class II 2000-05-12
K000950 EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201 Labotect Labor-Technik Gottingen MQF Class II 2000-05-12
K001212 TROJAN EXTRA LARGE LATEX CONDOM Armkel, LLC HIS Class II 2000-05-09
K991472 MEDI-CULT EMBRYO FREEZING MEDIUM INTERNAL CATAGLOG NUMBERS 1079 Medicult A/S MQL Class II 2000-05-09
K991471 MEDI-CULT BLASTOCYST FREEZING & THAWING PACKS, INTERNAL CATALOG NUMBERS (1012, 1015) Medicult A/S MQL Class II 2000-05-09
K000940 HUMAN SERUM ALBUMIN (HSA) Invitrocare, Inc. MQL Class II 2000-05-04
K991327 MEDI-CULT FLUSHING MEDIUM Medicult A/S MQL Class II 2000-05-04
K991332 MEDI-CULT SPERM PREPARATION - MEDIUM; Medicult A/S MQL Class II 2000-05-04
K000939 HTF-HEPES Invitrocare, Inc. MQL Class II 2000-05-04
DEN000006 EROS-CLITORAL THERAPY DEVICE (CTD) Urometrics, Inc. NBV Class II 2000-04-28
K000227 UMBICUT Pollak (Intl.), Ltd. HFW Class II 2000-04-27
K000444 MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM Prism Enterprises, Inc. HIB Class II 2000-04-21
K001130 3D MANUAL COARSE MANIPULATOR MN-188NE Narishige Co., Ltd. MQJ Class II 2000-04-21
K000212 KSEA CHARDONNES MORCELLATION KNIFE KARL STORZ Endoscopy-America, Inc. KOH Class I 2000-04-21
K001131 3D HDRAULIC FINE MICROMANIPULATOR MO-188NE Narishige Co., Ltd. MQJ Class II 2000-04-21
K000340 HYSTALOG HSG CATHETER Rocket Medical Plc HES Class II 2000-04-19
K991380 OIL FOR TISSUE CULTURE Advanced Reproductive Technologies MQL Class II 2000-04-19
K000408 LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM Suretex Prophylactics , Ltd. HIS Class II 2000-04-19
K000205 EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES Rocket Medical Plc MQE Class II 2000-04-19
K000117 AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE Avid Medical, Inc. HEE Class II 2000-04-13
K000199 CORTEK MINI LAPAROSCOPE Cortek Endoscopy, Inc. HET Class II 2000-04-13
K000748 TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT Armkel, LLC HIS Class II 2000-04-06
K000414 MEDISUL DISPOSABLE VAGINAL SPECULUM Marketing Perspectives HIB Class II 2000-04-04
K000027 INSUFFLATION NEEDLE, MODEL R65-933 A & A Medical, Inc. HIF Class II 2000-04-03
K000026 APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER Apple Medical Corp. HHK Class II 2000-03-31
K994353 SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 Precision Dynamics Corp. HFM Class II 2000-03-22
K994312 MALE LATEX CONDOM 56MM Pleasure Latex Products Sdn. Bhd. HIS Class II 2000-03-21
K000039 INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED Indus Medicare , Ltd. HIS Class II 2000-03-21
K994311 MALE LATEX CONDOM WITH VANILLA FLAVOR Pleasure Latex Products Sdn. Bhd. HIS Class II 2000-03-21
K000040 INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED Indus Medicare , Ltd. HIS Class II 2000-03-21
K000038 INVIGRA MALE LATEX CONDOM GREEN COLORED AND MINT FLAVORED Indus Medicare , Ltd. HIS Class II 2000-03-21
K993953 OVES CERVICAL CAP Veos , Ltd. HDR Class II 2000-03-21
K993733 LOVE LOCKERS Medtech Products , Ltd. HIS Class II 2000-03-20
K993735 DOUBLE SPRINGERS Medtech Products , Ltd. HIS Class II 2000-03-20
K993737 MIGHTY MAN (DYNAMIC LINKERS) Medtech Products , Ltd. HIS Class II 2000-03-20
K992513 THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh HET Class II 2000-03-17
K992481 CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh HET Class II 2000-03-17
K994367 UMBILICAL CORD CLAMP Medical Sales Co. HFW Class II 2000-03-17
K000309 BLASTOCYST FREEZE MEDIUM, BLASTOCYST THAW MEDIUM Irvine Scientific Sales Co., Inc. MQL Class II 2000-03-13
K992655 FERTILOSCOPY KIT FH 1.29/FTO 1.40 Soprane S.A. HEW Class II 2000-03-13
K000628 WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733 Sims Portex , Ltd. MQE Class II 2000-03-13
K000656 EMBRYON GIFT TRANSFER CATHETERS/SETS Rocket Medical Plc MQF Class II 2000-03-09
K991271 OOCYTE ASPIRATION NEEDLE Casmed UK MQE Class II 2000-03-08
K991470 MEDI-CULT ACIDIFIED TYRODES SOLUTION- MEDIUM; INTERNAL CATALOG NUMBERS (1060) Medicult A/S MQL Class II 2000-03-07
K994417 OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING Cook Urological, Inc. MQE Class II 2000-03-01
K994079 REFLEX TREATMENT SYSTEM Deschutes Medical Products, Inc. HIR Class II 2000-03-01
K000394 CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT Rocket Medical Plc MQG Class II 2000-02-29
K994327 EMBRYON TRANSFER CATHETERS/SETS Rocket Medical Plc MQF Class II 2000-02-28
K991333 MEDI-CULT SPERM FREEZE MEDIUM Medicult A/S MQL Class II 2000-02-28
K991335 MEDI-CULT FREEZING & THAWING PACKS Medicult A/S MQL Class II 2000-02-28
K991329 MEDI-CULT PVP MEDIUM, MEDI-CULT PVP CLINICAL GRADE Medicult A/S MQL Class II 2000-02-25
K991351 OVOIL-150, MODEL 5002 Vitrolife Sweden AB MQL Class II 2000-02-25
K991330 MEDI-CULT LIQUID PARAFFIN Medicult A/S MQL Class II 2000-02-25
K991346 PH-100, MODEL 2104 Vitrolife Sweden AB MQL Class II 2000-02-24
K991345 ASP-100, MODEL 2100 Vitrolife Sweden AB MQL Class II 2000-02-18
K994361 ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL Genesis Industries, Inc. MQK Class II 2000-02-18
K993396 REMED MALE EXTRA STRENGTH CONDOM PREVENTOR, LUCKY BOY, SUMMIT Remed Pharma HIS Class II 2000-02-15
K991395 QUINN'S HTF MEDIUM, QUINN'S HTF MEDIUM WITH HEPES, QUINN'S BASAL XI HTF MEDIUM, QUINN'S D3+ HTF MEDIUM Advanced Reproductive Technologies MQL Class II 2000-02-15
K993395 REMED MALE LATEX CONDOM (DOUBLE WHOOPER) PREVENTOR, LUCKY BOY AND SUMMIT Remed Pharma HIS Class II 2000-02-15
K993404 REMED MALE LATEX CONDOM (CLASSIC) PREVENTOR, LUCKY BOY, AND SUMMIT Remed Pharma HIS Class II 2000-02-15
K993405 REMED MALE DOTTED CONDOM PREVENTOR, LUCKY BOY, SUMMIT Remed Pharma HIS Class II 2000-02-15
K991396 WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L Sage Biopharma MQL Class II 2000-02-15
K993408 REMED MALE RIBBED CONDOM PREVENTOR, LUCKY BOY SUMMIT Remed Pharma HIS Class II 2000-02-15
K993390 REMED MALE LATEX CONDOM (SUPER DUPER) PREVENTOR, LUCKY BOY, AND SUMMIT Remed Pharma HIS Class II 2000-02-14
K993881 GENX CULTURE DISH <Genx> Intl., Inc. MQK Class II 2000-02-14
K993884 GENX MICROTOOLS <Genx> Intl., Inc. MQJ Class II 2000-02-14
K993801 GYNECARE LAPAROSCOPIC MORCELLATOR ETHICON, Inc. HET Class II 2000-02-07
K993804 KSEA RIGID CULDOSCOPE AND ACCESSORIES KARL STORZ Endoscopy-America, Inc. HEW Class II 2000-02-07
K991392 HUMAN SERUM ALBUMIN Advanced Reproductive Technologies MQL Class II 2000-02-07
K993794 PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS Playtime Products, Inc. HEB Class II 2000-02-07
K991379 QUINN'S SPERM WASHING MEDIUM Advanced Reproductive Technologies MQL Class II 2000-02-02

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