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
3155 Obstetrics & Gynecology devices
Cleared
Dec 15, 2005
YUSHENG DISPOSABLE VAGINAL SPECULUM
HIB
Speculum, Vaginal, Nonmetal
59d
Cleared
Dec 12, 2005
LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP
HGX
Pump, Breast, Powered
147d
Cleared
Nov 22, 2005
IUI CATHETER, MODEL 9057
MQF
Catheter, Assisted Reproduction
116d
Cleared
Nov 09, 2005
DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE
HIB
Speculum, Vaginal, Nonmetal
76d
Cleared
Nov 01, 2005
EVENFLO ELAN BREAST PUMP
HGX
Pump, Breast, Powered
15d
Cleared
Oct 17, 2005
CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE
HEE
Set, Anesthesia, Paracervical
49d
Cleared
Oct 07, 2005
OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH
MQE
Needle, Assisted Reproduction
101d
Cleared
Oct 04, 2005
FETAL MONITOR, MODELS BT-300 AND BT-200
HGM
System, Monitoring, Perinatal
54d
Cleared
Sep 22, 2005
ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101
HGX
Pump, Breast, Powered
55d
Cleared
Sep 08, 2005
ZIVF-AIRE
MQG
Accessory, Assisted Reproduction
415d
Cleared
Sep 07, 2005
WHITTLESTONE EXPRESSER
HGX
Pump, Breast, Powered
128d
Cleared
Sep 02, 2005
MANIPUSEAL
HEW
Culdoscope (and Accessories)
120d
Cleared
Sep 02, 2005
MCCARTNEY ACCESS TUBE
HEW
Culdoscope (and Accessories)
78d
Cleared
Aug 31, 2005
O'MY NATURAL LUBRICANT, O'MY NATURAL FLAVORED LUBRICANT
NUC
Lubricant, Personal
314d
Cleared
Aug 29, 2005
ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100
HGX
Pump, Breast, Powered
90d
Cleared
Aug 25, 2005
REMOTE CARE
HGM
System, Monitoring, Perinatal
205d
Cleared
Aug 19, 2005
DIVAS DUAL PLEASURE MALE LATEX CONDOM
HIS
Condom
94d
Cleared
Aug 18, 2005
TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
HGM
System, Monitoring, Perinatal
283d
Cleared
Aug 05, 2005
UGYTEX SUAL KNIT MESH
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
59d
Cleared
Aug 03, 2005
AMS PELVIC FLOOR REPAIR SYSTEM
OTO
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
58d
Cleared
Jul 14, 2005
FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS
HIL
Tampon, Menstrual, Scented, Scented-deodorized
42d
Cleared
Jul 11, 2005
GONGDONG DISPOSABLE VAGINAL SPECULUM
HIB
Speculum, Vaginal, Nonmetal
95d
Cleared
Jul 08, 2005
THE ART OF INTIMACY RESPONSE PERSONAL LUBRICANT
NUC
Lubricant, Personal
16d
Cleared
Jun 21, 2005
MODEL 250 SERIES MATERNAL/FETAL MONITOR
HGM
System, Monitoring, Perinatal
106d
Cleared
Jun 17, 2005
POLYFORM SYNTHETIC MESH
OTO
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
32d
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