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
Feb 03, 2011
MONICA AN24
OSP
Uterine Electromyographic Monitor
220d
Cleared
Jan 25, 2011
SURECALL EMG LABOR MONITOR
OSP
Uterine Electromyographic Monitor
734d
Cleared
Jan 14, 2011
GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3
MQL
Media, Reproductive
476d
Cleared
Jan 13, 2011
FETAL MONITORS, MODELS F2 AND F3
HGM
System, Monitoring, Perinatal
168d
Not Cleared
Jan 13, 2011
HEM-AVERT PERIANAL STABILIZER
OOA
Hemorrhoid Prevention Pressure Wedge
513d
Cleared
Jan 11, 2011
EMBRYOSCOPE AND EMBRYOSLIDE
MQG
Accessory, Assisted Reproduction
539d
Cleared
Jan 11, 2011
BT-CATH
OQY
Intrauterine Tamponade Balloon
222d
Cleared
Jan 06, 2011
CENTRAL MONITORING SYSTEM
HGM
System, Monitoring, Perinatal
328d
Cleared
Dec 22, 2010
SIMPLYGO BREAST PUMP
HGX
Pump, Breast, Powered
103d
Cleared
Dec 20, 2010
ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY
HEX
Colposcope (and Colpomicroscope)
679d
Cleared
Dec 10, 2010
RAPIDVIT BLAST, RAPIDWARM BLAST
MQL
Media, Reproductive
242d
Cleared
Dec 10, 2010
U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS
HEB
Tampon, Menstrual, Unscented
30d
Cleared
Dec 06, 2010
CRYOPETTE
MQK
Labware, Assisted Reproduction
279d
Cleared
Dec 06, 2010
MEDICON MOGEN CLAMP
HFX
Clamp, Circumcision
248d
Cleared
Nov 10, 2010
FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS
HGM
System, Monitoring, Perinatal
233d
Cleared
Nov 10, 2010
ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS
HEB
Tampon, Menstrual, Unscented
76d
Cleared
Nov 05, 2010
HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)
HGY
Pump, Breast, Non-powered
155d
Cleared
Oct 15, 2010
MYOSURE ROD LENS SCOPE SEALS
HIH
Hysteroscope (and Accessories)
28d
Cleared
Oct 06, 2010
HSV STRAW
MQK
Labware, Assisted Reproduction
426d
Cleared
Oct 01, 2010
MICROMED PD-8K INSULATION DEFECT DETECTOR
HFG
Coagulator, Laparoscopic, Unipolar (and Accessories)
115d
Cleared
Sep 27, 2010
VESSEL GUARDIAN
HIF
Insufflator, Laparoscopic
60d
Cleared
Sep 17, 2010
E-BASIC SINGLE BREAST PUMP
HGX
Pump, Breast, Powered
144d
Cleared
Aug 27, 2010
MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229
MQL
Media, Reproductive
196d
Cleared
Aug 17, 2010
REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUSABLE APPLICATOR) MODEL: 83035
NUC
Lubricant, Personal
119d
Cleared
Aug 17, 2010
REPLENS LONG-LASTING VAGINAL MOISTURIZER (PRE-FILLED APPLICATOR)
NUC
Lubricant, Personal
105d
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