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 10, 2008
MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS
HEB
Tampon, Menstrual, Unscented
175d
Cleared
Sep 03, 2008
EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED
MQL
Media, Reproductive
195d
Cleared
Sep 02, 2008
G-IVF G5 SERIES
MQL
Media, Reproductive
137d
Cleared
Aug 25, 2008
ORTHO ALL-FLEX DIAPHRAGM
HDW
Diaphragm, Contraceptive (and Accessories)
231d
Cleared
Aug 22, 2008
PINNACLE PELVIC FLOOR REPAIR KIT II
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
130d
Cleared
Aug 20, 2008
BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH
MQK
Labware, Assisted Reproduction
48d
Cleared
Aug 13, 2008
SUNIVF DISHES
MQK
Labware, Assisted Reproduction
182d
Cleared
Aug 07, 2008
LOVE GUARD MALE LATEX CONDOM
HIS
Condom
135d
Cleared
Jul 23, 2008
INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM
HIH
Hysteroscope (and Accessories)
99d
Cleared
Jul 16, 2008
PRE-VA VAGINAL LUBRICANT
PEB
Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
293d
Cleared
Jul 10, 2008
WATER WORKS DOUCHING DEVICE
HED
Douche Apparatus, Vaginal, Therapeutic
167d
Cleared
Jul 08, 2008
BIRTHTRACK
NPB
System, Monitoring, For Progress Of Labor
120d
Cleared
Jun 27, 2008
TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED
HIL
Tampon, Menstrual, Scented, Scented-deodorized
24d
Cleared
Jun 19, 2008
DUREX SYNTHETIC POLYISOPRENE MALE CONDOM
MOL
Condom, Synthetic
318d
Cleared
May 28, 2008
OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00
HGM
System, Monitoring, Perinatal
30d
Cleared
May 19, 2008
INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES
MQH
Microtools, Assisted Reproduction (pipettes)
248d
Cleared
May 15, 2008
GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
346d
Cleared
May 14, 2008
CONCEIVEX LATEX-FREE SEMEN COLLECTOR
OBB
Kit, Conception-assist, Home Use
58d
Cleared
May 07, 2008
DUREX PLAY TINGLING AQUEOUS BASED LUBRICANT
NUC
Lubricant, Personal
271d
Cleared
May 02, 2008
PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK
GEI
Electrosurgical, Cutting & Coagulation & Accessories
109d
Cleared
Apr 17, 2008
INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEM
HIH
Hysteroscope (and Accessories)
111d
Cleared
Apr 10, 2008
ELEGANCE WOMAN'S LUBRICANT
NUC
Lubricant, Personal
406d
Cleared
Apr 10, 2008
AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
76d
Cleared
Apr 09, 2008
NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912
HGM
System, Monitoring, Perinatal
71d
Cleared
Apr 01, 2008
DUREX PLAY SOFT & SENSUAL LUBRICANT
NUC
Lubricant, Personal
292d
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