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
Jul 13, 2012
MONICA AN24
OSP
Uterine Electromyographic Monitor
330d
Cleared
Jul 13, 2012
RI MSC (MIGRATION SEDIMENTATION CHAMBER)
MQK
Labware, Assisted Reproduction
326d
Cleared
Jul 13, 2012
LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR,
HEB
Tampon, Menstrual, Unscented
148d
Cleared
Jul 11, 2012
POISE PERSONAL LUBRICANT
NUC
Lubricant, Personal
131d
Cleared
Jul 03, 2012
ORANGE COLORED CONDOMS ORANGE SCENT
HIS
Condom
263d
Cleared
Jul 03, 2012
MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
HIF
Insufflator, Laparoscopic
61d
Cleared
Jun 29, 2012
TUBALGATOR
HIN
Coagulator-cutter, Endoscopic, Bipolar (and Accessories)
255d
Cleared
Jun 22, 2012
CARBONAID C02 DIFFUSER
HIF
Insufflator, Laparoscopic
261d
Cleared
Jun 21, 2012
PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS
HIL
Tampon, Menstrual, Scented, Scented-deodorized
146d
Cleared
Jun 20, 2012
MICROMANIPULATOR SET
MQJ
Micromanipulators And Microinjectors, Assisted Reproduction
89d
Cleared
Jun 19, 2012
TROJAN HER PLEASURE (RIBBED) ECSTASY LATEX CONDOM WITH LUBRICANT
HIS
Condom
140d
Cleared
Jun 18, 2012
MATRIXBRUSH ENDOMETRIAL SAMPLER
HFE
Brush, Endometrial
270d
Cleared
Jun 14, 2012
OBIX PERINATAL DATA SYSTEM 7.0
HGM
System, Monitoring, Perinatal
55d
Cleared
Jun 11, 2012
ARTISYN Y-SHAPED MESH
OTO
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
224d
Cleared
Jun 06, 2012
MULTIPURPOSE HANDLING MEDIUM
MQL
Media, Reproductive
54d
Cleared
May 31, 2012
CLOSER TO NATURE
HGX
Pump, Breast, Powered
29d
Cleared
May 24, 2012
RHEA CUP
HHE
Cup, Menstrual
301d
Cleared
May 17, 2012
RESTORELLE POLYPROPYLENE Y MESH
OTO
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
279d
Cleared
May 16, 2012
TROJAN MAGNUM CONDOM WITH FIRE & ICE LUBRICANT
HIS
Condom
106d
Cleared
May 11, 2012
TROJAN MAGNUM CONDOM WITH WARMING LUBRICANT
HIS
Condom
105d
Cleared
May 10, 2012
LUCINA-MELODI
HGX
Pump, Breast, Powered
223d
Cleared
May 10, 2012
VERTESSA
OTO
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
98d
Cleared
May 08, 2012
LIFESTYLES ZERO LUBRICATED LATEX CONDOM
HIS
Condom
90d
Cleared
May 03, 2012
LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES
MQL
Media, Reproductive
287d
Cleared
Apr 24, 2012
HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS
MRX
System, Assisted Reproduction Laser
106d
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