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
Apr 28, 2014
BRELLA-SPEC(TM) VAGINAL SPECULUM
HIB
Speculum, Vaginal, Nonmetal
130d
Cleared
Apr 24, 2014
ELECTRIC BREAST PUMP
HGX
Pump, Breast, Powered
223d
Cleared
Apr 23, 2014
EUM 100PRO
OSP
Uterine Electromyographic Monitor
302d
Cleared
Apr 23, 2014
ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS
HEB
Tampon, Menstrual, Unscented
247d
Cleared
Apr 23, 2014
XQ-1 INCUBATOR
MQG
Accessory, Assisted Reproduction
135d
Cleared
Apr 22, 2014
INSTINCT
HIS
Condom
264d
Cleared
Apr 21, 2014
KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA
HES
Insufflator, Carbon-dioxide, Uterotubal (and Accessories)
26d
Cleared
Apr 16, 2014
SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS
MQL
Media, Reproductive
133d
Cleared
Apr 11, 2014
JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS
HCZ
Forceps, Surgical, Gynecological
101d
Cleared
Apr 10, 2014
ONTEX AND OTHERS PROPRIETARY NAMES
HIL
Tampon, Menstrual, Scented, Scented-deodorized
268d
Cleared
Apr 08, 2014
THE GYNOCULAR
HEX
Colposcope (and Colpomicroscope)
246d
Cleared
Apr 03, 2014
CRYOTOP(R) SC
MQK
Labware, Assisted Reproduction
80d
Not Cleared
Mar 28, 2014
IOGYN SYSTEM
PGT
Insufflator, Hysteroscopic, Fluid, Closed-loop Recirculation With Cutter-coagulator, Endoscopic, Bipolar
210d
Cleared
Mar 19, 2014
SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE
PGK
Cannula, Injector, Uterine, Endometrial Biopsy
153d
Cleared
Mar 07, 2014
MALE LATEX CONDOM
HIS
Condom
242d
Cleared
Mar 05, 2014
INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT
HIF
Insufflator, Laparoscopic
30d
Cleared
Feb 24, 2014
EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES
NAJ
Agents, Embolic, For Treatment Of Uterine Fibroids
104d
Cleared
Feb 20, 2014
PROINSERT
MQK
Labware, Assisted Reproduction
303d
Cleared
Feb 12, 2014
RESTORELLE Y CONTOUR MESH
OTO
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
27d
Cleared
Feb 07, 2014
SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM
HGM
System, Monitoring, Perinatal
165d
Cleared
Jan 31, 2014
LINA GOLD LOOP HC
KNF
Coagulator-cutter, Endoscopic, Unipolar (and Accessories)
205d
Cleared
Jan 24, 2014
FETAL ULTRASONIC MONITOR AND ACCESSORIES
KNG
Monitor, Ultrasonic, Fetal
249d
Cleared
Jan 17, 2014
IOB DISPOSABLE SPECULUM
HIB
Speculum, Vaginal, Nonmetal
143d
Cleared
Jan 10, 2014
PANPAC WORD/BARTHOLIN CATHETER
KNA
Instrument, Manual, Specialized Obstetric-gynecologic
361d
Cleared
Jan 09, 2014
CRYOLOCK
MQK
Labware, Assisted Reproduction
470d
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