FDA 510(k) Obstetrics & Gynecology Devices
FDA 510(k) Obstetrics & Gynecology Devices - Regulatory Overview
FDA 510(k) obstetrics and gynecology (OB/GYN) devices include diagnostic and therapeutic equipment for women's reproductive health. The FDA review panel code is OB.
Key categories:
- Fetal monitoring systems - CTG monitors, fetal dopplers, scalp electrodes
- Intrauterine devices (IUDs) - hormonal and copper contraceptive devices
- Breast pumps and lactation aids - electric and manual breast pumps
- Gynecological surgical instruments - hysteroscopes, laparoscopic tools, ablation systems
- Pregnancy test systems - hCG detection devices for professional and home use
4525
Total
4511
Cleared
167d
Avg (2y)
1976
Since
4525 Obstetrics & Gynecology devices
Cleared
May 01, 2009
ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM
HIS
Condom
241d
Cleared
Apr 29, 2009
COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS
MQL
Media, Reproductive
254d
Cleared
Apr 29, 2009
MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS
HEB
Tampon, Menstrual, Unscented
14d
Cleared
Apr 24, 2009
LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA
MQL
Media, Reproductive
149d
Cleared
Apr 23, 2009
WALGREEN'S PERSONAL LUBRICATING JELLY
NUC
Lubricant, Personal
381d
Cleared
Apr 09, 2009
PAPCONE
HHT
Spatula, Cervical, Cytological
182d
Cleared
Apr 02, 2009
ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
15d
Cleared
Mar 31, 2009
ASCEND
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
106d
Cleared
Mar 31, 2009
OKAMOTO ULTRA THIN
HIS
Condom
57d
Cleared
Mar 30, 2009
KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1
HIF
Insufflator, Laparoscopic
369d
Cleared
Mar 04, 2009
LABORPRO SYSTEM
NPB
System, Monitoring, For Progress Of Labor
236d
Cleared
Feb 18, 2009
COTTONS 100% NATURAL COTTON TAMPONS
HEB
Tampon, Menstrual, Unscented
341d
Cleared
Feb 13, 2009
AIRSTRIP OB
HGM
System, Monitoring, Perinatal
10d
Cleared
Feb 06, 2009
MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP
HGX
Pump, Breast, Powered
259d
Cleared
Feb 06, 2009
KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED
HIS
Condom
219d
Cleared
Feb 06, 2009
MODEL PC-860 FETAL DOPPLER
KNG
Monitor, Ultrasonic, Fetal
200d
Cleared
Feb 06, 2009
FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN
MQE
Needle, Assisted Reproduction
142d
Cleared
Jan 30, 2009
MAXIM HYGIENE ORGANICALLY GROWN COTTON TAMPON
HEB
Tampon, Menstrual, Unscented
15d
Cleared
Jan 23, 2009
AIRSTRIP OB
HGM
System, Monitoring, Perinatal
14d
Cleared
Jan 22, 2009
ENDEARE BREAST PUMP
HGX
Pump, Breast, Powered
199d
Cleared
Jan 15, 2009
AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
23d
Cleared
Jan 14, 2009
MODIFICATION TO URESTA PESSARY
HHW
Pessary, Vaginal
27d
Cleared
Jan 09, 2009
BIRTHTRACK (A.K.A. CLM)
NPB
System, Monitoring, For Progress Of Labor
115d
Cleared
Jan 07, 2009
NEO-VAGINA SURGERY SET AND ACCESSORIES
HDX
Dilator, Vaginal
559d
Cleared
Dec 23, 2008
ENDOSCOPIC CO2 REGULATION UNIT UCR
HET
Laparoscope, Gynecologic (and Accessories)
243d
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