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
Dec 23, 2015
ENDOPLUS hand-held laparoscopic instruments
HFI
Coagulator, Culdoscopic (and Accessories)
196d
Cleared
Dec 21, 2015
FreezeKit Cleave , ThawKit Cleave
MQL
Media, Reproductive
257d
Cleared
Dec 21, 2015
Electric Double Breast Pumps
HGX
Pump, Breast, Powered
221d
Cleared
Dec 21, 2015
SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT
MQL
Media, Reproductive
87d
Cleared
Dec 21, 2015
Ally Uterine Positioning System
LKF
Cannula, Manipulator/injector, Uterine
56d
Cleared
Dec 18, 2015
Flexipet Denuding Pipette, Flexipet Manipulation Pipette
MQH
Microtools, Assisted Reproduction (pipettes)
270d
Cleared
Dec 18, 2015
O-RING Condom
HIS
Condom
263d
Cleared
Dec 18, 2015
Always/Tampax bladder supports
HHW
Pessary, Vaginal
205d
Cleared
Dec 04, 2015
EmbryoSlide Culture Dish
MQK
Labware, Assisted Reproduction
238d
Cleared
Dec 04, 2015
COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS
HEB
Tampon, Menstrual, Unscented
114d
Cleared
Dec 03, 2015
SYDNEY IVF EMBRYO BIOPSY MEDIUM
MQL
Media, Reproductive
63d
Cleared
Dec 01, 2015
Video Colposcope
HEX
Colposcope (and Colpomicroscope)
145d
Cleared
Nov 23, 2015
MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter
MQF
Catheter, Assisted Reproduction
334d
Cleared
Nov 20, 2015
SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link
HET
Laparoscope, Gynecologic (and Accessories)
263d
Cleared
Nov 19, 2015
Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla
NUC
Lubricant, Personal
307d
Cleared
Nov 13, 2015
MAKO Device
HIH
Hysteroscope (and Accessories)
184d
Cleared
Nov 13, 2015
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
HIH
Hysteroscope (and Accessories)
52d
Cleared
Nov 12, 2015
Water Based Personal Lubricant with Flavours
NUC
Lubricant, Personal
234d
Cleared
Nov 09, 2015
Divine 9
NUC
Lubricant, Personal
264d
Cleared
Nov 06, 2015
Breast Pump
HGX
Pump, Breast, Powered
214d
Cleared
Nov 05, 2015
Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental
HGX
Pump, Breast, Powered
141d
Cleared
Nov 02, 2015
Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency
HEB
Tampon, Menstrual, Unscented
154d
Not Cleared
Nov 02, 2015
INVOcell
OYO
Culture, Intravaginal, Assisted Reproduction
252d
Cleared
Oct 20, 2015
Swiss Navy Premium Silicone Lubricant
NUC
Lubricant, Personal
270d
Cleared
Oct 13, 2015
GelPOINT Transvaginal Access Platform
HEW
Culdoscope (and Accessories)
329d
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