Atlas FDA

Obstetrics/Gynecology

4,608 FDA 510(k) clearances · Medical specialty

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE (K111614)Ge Healthcare Integrated IT Solutions2011-09-26
PD-100 SERIES ULTRASONIC POCKET DOPPLER (K111934)Advanced Instrumentations, Inc.2011-09-22
FM-1000 PLUS FETAL MONITOR (K112187)Advanced Instrumentations, Inc.2011-09-21
CMS-1000FM CENTRAL MONITORING SYSTEM (K112159)Advanced Instrumentations, Inc.2011-09-21
KOLPLUX SYSTEM (K110766)Kolplast CI Ltda2011-09-15
LITE PELVIC FLOOR REPAIR KITS (K103426)Boston Scientific Corp2011-09-14
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM (K112386)Coloplast Corp.2011-09-08
ROMA (HE4 EIA + ARCHITECT CA 125 II) (K103358)Fujirebio Diagnostics,Inc.2011-09-01
GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) (K111059)Gyrus Acmi, Inc.2011-09-01
MONICA IF24 (K112163)Monica Healthcare2011-08-30
UNIMAX VERESS NEEDLE (K111441)Unimax Medical Systems, Inc.2011-08-19
PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50 (K111083)Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011-08-17
EMBRYOSCOPE (K111715)Unisense Fertilitech A/S2011-08-11
LUCINA MODEL MELODI (K102516)Genadyne Biotechnologies, Inc.2011-08-11
EEVATM PETRI DISH (K103028)Auxogyn, Inc.2011-08-11
DOLPHIN 3 FLUID MANAGEMENT SYSTEM (K110852)Gyrus Acmi, Inc.2011-07-19
MINI TELEMETRY SYSTEM (K110556)Wipro GE Healthcare Private, Ltd.2011-07-19
SURELIFT PROLAPSE SYSTEM (K102815)Neomedic International2011-07-07
AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE (K111118)American Medical Systems2011-07-01
VIBERECT PENILE VIBRATORY STIMULATION DEVICE (K110566)Reflexonic, LLC2011-06-24
F10 (K110630)Mediana Co., Ltd.2011-06-24
AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301 (K101641)Ag Digital Technology Corp.2011-06-16
BILLY BOY MALE LATEX CONDOM (K111093)Mapa GmbH2011-06-03
TAMPAX C PLASTIC TAMPONS, UNSCENTED (K110669)The Procter & Gamble Co.2011-06-02
SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 (K103692)Surgiquest, Inc.2011-05-25
BT-350 (K103545)Bistos Co., Ltd.2011-05-13
K-Y BRAND LONG LASTING VAGINAL MOISTURIZER (K101585)Johnson & Johnson Consumer & Personal Products Wor2011-05-10
COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) (K102141)Cook Urological, Inc.2011-05-06
HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0 (K102263)Mckesson Information Solutions, LLC2011-05-05
FEMVUE SALINE-AIR DEVICE (K110288)Femasys, Inc.2011-04-28
INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA (K102480)Jieying Laboratory, Inc.2011-04-19
DISPOSABLE ENDOMETRIAL SUCTION CURETTE (K102847)Jiangsu Suyun Medical Materials Co., Ltd.2011-04-14
ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE (K110147)Sti Medical Systems, LLC2011-04-08
TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM (K100767)Church & Dwight Co., Inc.2011-04-05
TRUCLEAR MORCELLATOR SYSTEM (K110038)Smith & Nephew, Inc.2011-03-30
TRUCLEAR INCISOR PLUS BLADE 2.9 (K103389)Smith & Nephew, Inc.2011-03-25
PHILIPS AVALON FETAL MONITOR (K102958)Philips Medizin Systeme Boblingen GmbH2011-03-18
LINA XCISE MODEL MOR-1515 (K101458)Lina Medical Aps2011-03-11
TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP (K110343)Mayborn Baby and Child / Jackel International, Ltd.2011-03-11
CIV-OB (PLUS) (K103172)Civnet Communication, Ltd.2011-03-11
DYSIS (K092433)Forth Photonics Hellas SA2011-03-10
TROKAMED MORCELLATOR (K091010)Trokamed GmbH2011-03-01
BILLY BOY MALE LATEX CONDOM (K103119)Sheila Pickering PHD2011-02-24
HEAL FORCE CO2 INCUBATOR (K101988)Shanghai Lishen Scientific Equipment Co., Ltd.2011-02-08
FETAL DOPPLER JPD-100S (K110124)Shenzhen Jumper Medical Equipment Co., Ltd.2011-02-04
MONICA AN24 (K101801)Monica Healthcare2011-02-03
SURECALL EMG LABOR MONITOR (K090145)Reproductive Research Technologies, LP2011-01-25
GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3 (K092963)Genx Intl., Inc.2011-01-14
HEM-AVERT PERIANAL STABILIZER (DEN090011)Plexus Biomedical, Inc.2011-01-13
FETAL MONITORS, MODELS F2 AND F3 (K102140)Edan Instruments, Inc.2011-01-13
EMBRYOSCOPE AND EMBRYOSLIDE (K092183)Unisense Fertilitech A/S2011-01-11
BT-CATH (K101535)Utah Medical Products, Inc.2011-01-11
CENTRAL MONITORING SYSTEM (K100358)Edan Instruments, Inc.2011-01-06
SIMPLYGO BREAST PUMP (K102600)Evenflo Company, Inc.2010-12-22
ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY (K090324)Sti Medical Systems2010-12-20
U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS (K103311)Kimberly Clark Corporation2010-12-10
RAPIDVIT BLAST, RAPIDWARM BLAST (K101003)Vitrolife Sweden AB2010-12-10
MEDICON MOGEN CLAMP (K100916)Medicon EG2010-12-06
CRYOPETTE (K100596)Mid-Atlantic Diagnostics, Inc.2010-12-06
FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS (K100797)Edan Instruments, Inc.2010-11-10
ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS (K102445)Rostam , Ltd.2010-11-10
HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) (K101538)Philips Electronics UK Limited2010-11-05
ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER (K102138)Edan Instruments, Inc.2010-10-28
MYOSURE ROD LENS SCOPE SEALS (K102686)Interlace Medical, Inc.2010-10-15
HSV STRAW (K092398)Cryo Bio System2010-10-06
MICROMED PD-8K INSULATION DEFECT DETECTOR (K101606)Mcgan Technology, LLC2010-10-01
VESSEL GUARDIAN (K102136)Lexion Medical, LLC2010-09-27
E-BASIC SINGLE BREAST PUMP (K101157)Mapa GmbH2010-09-17
MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229 (K100367)Origio A/S2010-08-27
REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUSABLE APPLICATOR) MODEL: 83035 (K101098)Lil Drug Store Products, Inc.2010-08-17
REPLENS LONG-LASTING VAGINAL MOISTURIZER (PRE-FILLED APPLICATOR) (K101241)Lil Drug Store Products, Inc.2010-08-17
SPECTRA SERIES BREAST PUMP (K093145)Uzinmedicare Co.2010-08-13
SONOTRAX SERIES ULTRASONIC POCKET DOPPLER (K101960)Edan Instruments, Inc.2010-08-10
SEILER COLPOSCOPE, MODELS 935, 955 AND 985 (K101141)Seiler Precision Microscopes2010-08-06
PHILIPS OBTRACEVUE MODEL SW REV. G.00 (K100420)Philips Medizin Systeme Boeblingen GmbH2010-07-26
THE PANPAC SUCTION CURETTE (K092982)Panpac Medical Corporation2010-07-26
THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 (K091939)Thermedx, LLC2010-07-23
PANPAC VAGINAL PESSARY (K092981)Panpac Medical Corporation2010-07-22
SIMPLISSE ELECTRIC BREASTFEEDING COMPANION (K093648)Simplisse, Inc.2010-07-14
ECLERIS MICROSTAR COLPOSCOPE (K100595)Ecleris USA2010-07-09
BELLECUP (K092985)Librette, Inc.2010-06-28
VASOVAPOR (K101320)Lexion Medical, LLC2010-06-24
UNIMOM ALLEGRO (K100929)Blue Egg CO2010-06-16
VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010 (K092107)Nidacon International AB2010-06-15
FETAL MONITOR MODEL: BT-200T (K100885)Bistos Co., Ltd.2010-06-07
PANPAC HSG CATHETER SET (K092983)Panpac Medical Corporation2010-06-07
GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT (K092667)Genx Intl., Inc.2010-06-03
TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA (K091281)Procter & Gamble Co.2010-06-01
AMEDA PLATINUM BREAST PUMP (K100435)Evenflo Company, Inc.2010-05-28
DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200 (K100626)Shenzhen Biocare Electronics Co., Ltd.2010-05-21
FEMEYE TWO (K093218)Fem Suite, LLC2010-05-18
MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU (K092586)Innolatex (Thailand) Limited2010-05-12
HYALO GYN (K094039)Fidia Farmaceutici S.P.A.2010-05-07
H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET 7 FRENCH, MODEL 61-5007F (K092969)Sterling Medical, Inc.2010-04-30
BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM (K091958)Glenveigh Surgical, LLC2010-04-30
BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES (K092554)Sunlight Medical, Inc.2010-04-30
INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX (K100517)Instrumed International, Inc.2010-04-29
DOPPLER FETAL HEARTBEAT RATE DETECTOR (K090510)Shenzhen Bestman Instrument Co., Ltd.2010-04-29
GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER (K093904)Glenveigh Surgical, LLC2010-04-14
FEMVUE CORNUAL BALLOON CATHETER (K100662)Femasys, Inc.2010-04-07
← Previous Next →

Track Obstetrics/Gynecology automatically

Every clearance here is in the API, with alerts when new ones post.