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
Mar 20, 2000
LOVE LOCKERS
HIS
Condom
137d
Cleared
Mar 20, 2000
DOUBLE SPRINGERS
HIS
Condom
137d
Cleared
Mar 20, 2000
MIGHTY MAN (DYNAMIC LINKERS)
HIS
Condom
137d
Cleared
Mar 17, 2000
CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF
HET
Laparoscope, Gynecologic (and Accessories)
235d
Cleared
Mar 17, 2000
THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF
HET
Laparoscope, Gynecologic (and Accessories)
235d
Cleared
Mar 17, 2000
UMBILICAL CORD CLAMP
HFW
Clamp, Umbilical
81d
Cleared
Mar 13, 2000
BLASTOCYST FREEZE MEDIUM, BLASTOCYST THAW MEDIUM
MQL
Media, Reproductive
41d
Cleared
Mar 13, 2000
WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633
MQE
Needle, Assisted Reproduction
18d
Cleared
Mar 13, 2000
FERTILOSCOPY KIT FH 1.29/FTO 1.40
HEW
Culdoscope (and Accessories)
217d
Cleared
Mar 09, 2000
EMBRYON GIFT TRANSFER CATHETERS/SETS
MQF
Catheter, Assisted Reproduction
10d
Cleared
Mar 08, 2000
OOCYTE ASPIRATION NEEDLE
MQE
Needle, Assisted Reproduction
330d
Cleared
Mar 07, 2000
MEDI-CULT ACIDIFIED TYRODES SOLUTION- MEDIUM
MQL
Media, Reproductive
328d
Cleared
Mar 01, 2000
OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING
MQE
Needle, Assisted Reproduction
63d
Cleared
Feb 29, 2000
CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT
MQG
Accessory, Assisted Reproduction
22d
Cleared
Feb 28, 2000
MEDI-CULT SPERM FREEZE MEDIUM
MQL
Media, Reproductive
315d
Cleared
Feb 28, 2000
MEDI-CULT FREEZING & THAWING PACKS
MQL
Media, Reproductive
315d
Cleared
Feb 28, 2000
EMBRYON TRANSFER CATHETERS/SETS
MQF
Catheter, Assisted Reproduction
68d
Cleared
Feb 25, 2000
MEDI-CULT PVP MEDIUM, MEDI-CULT PVP CLINICAL GRADE
MQL
Media, Reproductive
312d
Cleared
Feb 25, 2000
MEDI-CULT LIQUID PARAFFIN
MQL
Media, Reproductive
312d
Cleared
Feb 25, 2000
OVOIL-150, MODEL 5002
MQL
Media, Reproductive
312d
Cleared
Feb 24, 2000
PH-100, MODEL 2104
MQL
Media, Reproductive
311d
Cleared
Feb 18, 2000
ASP-100, MODEL 2100
MQL
Media, Reproductive
305d
Cleared
Feb 18, 2000
ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL
MQK
Labware, Assisted Reproduction
53d
Cleared
Feb 15, 2000
QUINN'S HTF MEDIUM, QUINN'S HTF MEDIUM WITH HEPES, QUINN'S BASAL XI HTF MEDIUM, QUINN'S D3+ HTF MEDIUM
MQL
Media, Reproductive
300d
Cleared
Feb 15, 2000
WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L
MQL
Media, Reproductive
300d
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