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
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
Cleared
Mar 30, 2015
CENTRAL MONITORING SYSTEM
HGM
System, Monitoring, Perinatal
96d
Cleared
Mar 25, 2015
DISPOSABLE ENDOSCOPIC CANNULA
HGH
Cannula, Suction, Uterine
421d
Cleared
Mar 25, 2015
ebb Complete Tamponade System
OQY
Intrauterine Tamponade Balloon
19d
Cleared
Mar 20, 2015
SonoFlow Sonohysterography and Sonohysterosalpingography Device
LKF
Cannula, Manipulator/injector, Uterine
191d
Cleared
Mar 20, 2015
Fetal Doppler
HEK
Monitor, Heart Sound, Fetal, Ultrasonic
176d
Cleared
Mar 20, 2015
SurgiQuest AirSeal iFS System
HIF
Insufflator, Laparoscopic
112d
Cleared
Mar 10, 2015
Sense4Baby System Model B+ (MSA)
LQK
Home Uterine Activity Monitor
131d
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