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
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 09, 2005
MULTIPLE EROZONE BODYGLIDE FLUID, EROZONE BODYGLIDE GEL, EROZONE LATEX DRESSING, EROZONE BODYGLIDE NATURAL FOAM
NUC
Lubricant, Personal
537d
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
Cleared
Jun 10, 2005
XENFORM SOFT TISSUE REPAIR MATRIX
PAJ
Mesh, Surgical, Non-synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
31d
Cleared
Jun 08, 2005
ENHANCE CLITORAL STIMULATION AID
NBV
Device, Engorgement, Clitoral
174d
Cleared
May 12, 2005
FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
HEB
Tampon, Menstrual, Unscented
58d
Cleared
May 02, 2005
EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S
MQF
Catheter, Assisted Reproduction
62d
Cleared
Apr 28, 2005
ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4
MRX
System, Assisted Reproduction Laser
34d
Cleared
Apr 21, 2005
MEDELA SINGLE USE SILC CUP, MODEL 077.0791
HDB
Extractor, Vacuum, Fetal
311d
Cleared
Apr 21, 2005
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
HET
Laparoscope, Gynecologic (and Accessories)
63d
Cleared
Apr 14, 2005
CUMULASE
MQL
Media, Reproductive
212d
Cleared
Apr 14, 2005
VACULINK, MODEL VCL 3000
HDB
Extractor, Vacuum, Fetal
105d
Cleared
Apr 08, 2005
DUREX PLAY TINGLING LUBRICANT
NUC
Lubricant, Personal
163d
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