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
4507
Total
4493
Cleared
168d
Avg (2y)
1976
Since
3149 Obstetrics & Gynecology devices
Cleared
Jul 20, 2015
Medline Natural Lubricating Liquid
NUC
Lubricant, Personal
243d
Cleared
Jul 20, 2015
Micro well group culture dish, 9-well
MQK
Labware, Assisted Reproduction
119d
Cleared
Jul 20, 2015
Trojan Riviera Personal Lubricant
NUC
Lubricant, Personal
109d
Cleared
Jul 09, 2015
Model BT-220L and BT-220C
HGM
System, Monitoring, Perinatal
283d
Cleared
Jul 08, 2015
JO H20 Water Based Personal Lubricant
NUC
Lubricant, Personal
134d
Cleared
Jul 02, 2015
Tosama 100% Organic Cotton Menstrual Tampon
HEB
Tampon, Menstrual, Unscented
62d
Cleared
Jul 01, 2015
Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express
HGM
System, Monitoring, Perinatal
89d
Cleared
Jun 23, 2015
Ontex Unscented Tampons with Colored Plastic Applicators
HEB
Tampon, Menstrual, Unscented
270d
Cleared
Jun 17, 2015
ARDO Calypso Pro Powered Breast Pump
HGX
Pump, Breast, Powered
90d
Cleared
May 20, 2015
K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant
NUC
Lubricant, Personal
160d
Cleared
May 14, 2015
DISPOSABLE CERVICAL BRUSH
HHT
Spatula, Cervical, Cytological
385d
Cleared
May 06, 2015
Electric Breast Pump
HGX
Pump, Breast, Powered
139d
Cleared
May 01, 2015
Vaginal Moisturizing Gel
NUC
Lubricant, Personal
52d
Cleared
Apr 23, 2015
iBreastExam
NKA
System, Documentation, Breast Lesion
197d
Cleared
Apr 21, 2015
Melodi Prime Breast Pump
HGX
Pump, Breast, Powered
125d
Cleared
Apr 21, 2015
Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty
HGX
Pump, Breast, Powered
54d
Cleared
Apr 20, 2015
MALE CIRCUMCISION KITS:RAPIDECLAMP
HFX
Clamp, Circumcision
257d
Cleared
Apr 20, 2015
Tosama 100% Cotton Menstrual Tampon
HEB
Tampon, Menstrual, Unscented
18d
Cleared
Apr 17, 2015
JOY DROPS (TM) NATURAL PERSONAL LUBRICANT GEL
NUC
Lubricant, Personal
414d
Cleared
Apr 17, 2015
MindChild Meridian M100 Fetal Heart Rate Monitor
HGM
System, Monitoring, Perinatal
197d
Cleared
Apr 17, 2015
Dilapan-S
PKN
Dilator, Cervical, Synthetic, Osmotic
136d
Cleared
Apr 14, 2015
TheyFit Male Condom
HIS
Condom
90d
Cleared
Apr 06, 2015
PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME!
NUC
Lubricant, Personal
265d
Cleared
Apr 06, 2015
Vertessa Lite
OTO
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
91d
Cleared
Apr 06, 2015
Vertessa Lite Y-Mesh
OTO
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
90d
Looking for a specific obstetrics & gynecology device? Search by device name, K-number or manufacturer.
Search all Obstetrics & Gynecology 510(k) devices