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
Oct 23, 2009
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
HIH
Hysteroscope (and Accessories)
190d
Cleared
Oct 22, 2009
DEBP
HGX
Pump, Breast, Powered
42d
Cleared
Oct 16, 2009
THAI NIPPON MALE LATEX CONDOM
HIS
Condom
529d
Cleared
Oct 09, 2009
SIMPLYGO HANDS FREE BREAST PUMP
HGX
Pump, Breast, Powered
30d
Cleared
Sep 29, 2009
GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4
HIH
Hysteroscope (and Accessories)
63d
Cleared
Sep 25, 2009
ALPHA DUO LAP INSUFFLATOR
HIF
Insufflator, Laparoscopic
198d
Cleared
Sep 18, 2009
NUNC IVF CENTERWELL AND ICSI DISHES
MQK
Labware, Assisted Reproduction
211d
Cleared
Sep 16, 2009
M. DIOR BRAND
HIS
Condom
268d
Cleared
Sep 09, 2009
OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM
HIB
Speculum, Vaginal, Nonmetal
71d
Cleared
Sep 03, 2009
COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400
KNA
Instrument, Manual, Specialized Obstetric-gynecologic
336d
Cleared
Sep 03, 2009
INSUFLOW DEWHEART
HIF
Insufflator, Laparoscopic
118d
Cleared
Aug 26, 2009
INSUFLOW
HIF
Insufflator, Laparoscopic
184d
Cleared
Aug 25, 2009
SATURN ACTIVE LASER SYSTEM
MRX
System, Assisted Reproduction Laser
298d
Cleared
Aug 25, 2009
CERNER FETALINK (VERSION 1.0)
HGM
System, Monitoring, Perinatal
118d
Cleared
Aug 21, 2009
MYOSURE ROD LENS HYSTEROSCOPE
HIH
Hysteroscope (and Accessories)
95d
Cleared
Aug 07, 2009
PHARMAPAC PERSONAL LUBRICANT
NUC
Lubricant, Personal
72d
Cleared
Aug 04, 2009
RESTORELLE POLYPROPYLENE MESH
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
13d
Cleared
Jul 29, 2009
MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON
HEB
Tampon, Menstrual, Unscented
22d
Cleared
Jul 21, 2009
EZ HSG CATHETER.FOAMSEAL CATHETER
LKF
Cannula, Manipulator/injector, Uterine
228d
Cleared
Jul 15, 2009
SONICAID FM820 AND FM830 ENCORE
HGM
System, Monitoring, Perinatal
160d
Cleared
Jun 29, 2009
MORCE POWER PLUS AND VARIOCARVE MORCELLATOR
HET
Laparoscope, Gynecologic (and Accessories)
504d
Cleared
Jun 23, 2009
FEMVUE(TM) CATHETER SYSTEM
LKF
Cannula, Manipulator/injector, Uterine
193d
Cleared
May 28, 2009
ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS
HEB
Tampon, Menstrual, Unscented
136d
Cleared
May 08, 2009
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
164d
Cleared
May 08, 2009
PELVIC FLOOR REPAIR SYSTEM
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
18d
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