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
Aug 03, 2001
WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S
MQE
Needle, Assisted Reproduction
32d
Cleared
Aug 03, 2001
NIDOIL
MQL
Media, Reproductive
28d
Cleared
Jul 30, 2001
MITYVAC
HDB
Extractor, Vacuum, Fetal
73d
Cleared
Jul 22, 2001
HYSTEROSCOPES
HIH
Hysteroscope (and Accessories)
226d
Cleared
Jul 22, 2001
GYNECOLOGICAL LAPAROSCOPES
HET
Laparoscope, Gynecologic (and Accessories)
226d
Cleared
Jul 20, 2001
FLAVORED MALE LATEX CONDOM
HIS
Condom
87d
Cleared
Jul 18, 2001
OIL FOR EMBRYO CULTURE
MQL
Media, Reproductive
27d
Cleared
Jul 12, 2001
PURESPERM BUFFER
MQL
Media, Reproductive
49d
Cleared
Jul 09, 2001
US SENSOR #CG-930P
HEL
Monitor, Heart Rate, Fetal, Ultrasonic
206d
Cleared
Jul 09, 2001
MMODIFICATION TO LAMINARIA
HDY
Dilator, Cervical, Hygroscopic-laminaria
54d
Cleared
Jul 02, 2001
TAMPAX SCENTED & SATIN SCENTED TAMPAX-JUNIOR, REGULAR, SUPER & SUPER PLUS
HIL
Tampon, Menstrual, Scented, Scented-deodorized
76d
Cleared
Jul 02, 2001
10% PVP
MQL
Media, Reproductive
49d
Cleared
Jul 02, 2001
HYALURONIDASE IN HTF MEDIUM
MQL
Media, Reproductive
42d
Cleared
Jun 28, 2001
READYSWIM
MQL
Media, Reproductive
57d
Cleared
Jun 22, 2001
TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
HEL
Monitor, Heart Rate, Fetal, Ultrasonic
87d
Cleared
Jun 15, 2001
MALE NATURAL RUBBER LATEX CONDOM
HIS
Condom
80d
Cleared
Jun 13, 2001
LUNAPADS
NUQ
Pad, Menstrual, Reusable
72d
Cleared
Jun 13, 2001
OIL FOR TISSUE CULTURE
MQL
Media, Reproductive
30d
Cleared
Jun 13, 2001
WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE
MTW
System, Water, Reproduction, Assisted, And Purification
20d
Cleared
Jun 12, 2001
MM-87 MOTOR-DRIVE MANIPULATOR
MQJ
Micromanipulators And Microinjectors, Assisted Reproduction
34d
Cleared
Jun 11, 2001
AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY
KNF
Coagulator-cutter, Endoscopic, Unipolar (and Accessories)
90d
Cleared
May 29, 2001
OB-1 FETAL MONITOR
HGM
System, Monitoring, Perinatal
29d
Cleared
May 24, 2001
VIVA
HIS
Condom
10d
Cleared
May 16, 2001
BALLOON CANNULA, SHORT, MODEL R65-985
HET
Laparoscope, Gynecologic (and Accessories)
84d
Cleared
May 11, 2001
CG-900P FETAL/MATERNAL MONITOR
HGM
System, Monitoring, Perinatal
74d
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