FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
28585–28608 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 14, 2017
Vitality® Spinal Fixation System
K171907 · NKB
Zimmer Biomet Spine, Inc.
Orthopedic · 18d
Cleared Jul 13, 2017
SterilContainer S System
K162815 · KCT
Aesculap, Inc.
General Hospital · 280d
Cleared Jul 13, 2017
Kitazato ET Catheters
K162878 · MQF
Kitazato Corporation
Obstetrics & Gynecology · 272d
Cleared Jul 13, 2017
Coveris Cervical Cage System
K170550 · ODP
Camber Spine Technologies
Orthopedic · 139d
Cleared Jul 13, 2017
Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula
K170660 · HIH
CooperSurgical, Inc.
Obstetrics & Gynecology · 132d
Cleared Jul 13, 2017
HD Lumbar Interbody System
K170676 · MAX
Hd Lifesciences, LLC
Orthopedic · 129d
Cleared Jul 13, 2017
Unity Total Knee System
K170808 · JWH
Corin U.S.A. Limited
Orthopedic · 118d
Cleared Jul 13, 2017
KATANA Zirconia Block
K170986 · EIH
Kuraray Noritake Dental, Inc.
Dental · 101d
Cleared Jul 13, 2017
Axis Charcot Fixation System, 4.5 to 8.5mm Screw System
K171018 · HWC
Extremity Medical, LLC
Orthopedic · 99d
Cleared Jul 13, 2017
Genesys Spine Apache Interbody Fusion System
K171656 · MAX
Genesys Spine
Orthopedic · 38d
Cleared Jul 13, 2017
Velofix(tm) Interbody Fusion System
K171749 · ODP
U&I Corporation
Orthopedic · 30d
Cleared Jul 13, 2017
OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System
K171813 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 24d
Cleared CT Jul 12, 2017
Relizorb
K163057 · PLQ
Alcresta Therapeutics, Inc.
Gastroenterology & Urology · 253d
Cleared Jul 12, 2017
NIRA Beauty Skin Laser
K163137 · OHS
Dermal Photonics Corporation
General & Plastic Surgery · 245d
Cleared Jul 12, 2017
Borrelia B31 ViraChip IgG Test Kit
K163504 · LSR
Viramed Biotech AG
Microbiology · 210d
Cleared Jul 12, 2017
Reprocessed AcuNav Diagnostic Ultrasound Catheter
K163560 · OWQ
Innovative Health, LLC
Cardiovascular · 205d
Cleared Jul 12, 2017
Great Basin Stool Bacterial Pathogens Panel
K163571 · PCI
Great Basin Scientific, Inc.
Microbiology · 205d
Cleared Jul 12, 2017
NeoFuse Ti3D PLIF/TLIF/Cervical Interbody
K170318 · ODP
Ht Medical, LLC
Orthopedic · 161d
Cleared Jul 12, 2017
NerveGuard NRFit, NerveGuard LUER
K170435 · BSP
PAJUNK GmbH Medizintechnologie
Anesthesiology · 149d
Cleared Jul 12, 2017
Invacare® TDX® SP2 Power Wheelchair
K170507 · ITI
Invacare Corporation
Physical Medicine · 141d
Cleared Jul 12, 2017
P50 Series Digital Color Doppler Ultrasound System
K170999 · IYN
Sonoscape Medical Corp.
Radiology · 100d
Cleared Jul 12, 2017
TrueBeam, TrueBeam STx, Edge
K171733 · IYE
Varian Medical Systems, Inc.
Radiology · 30d
Cleared Jul 12, 2017
Acuson SC2000 Diagnostic Ultrasound System
K171766 · IYO
Siemens Medi Cal Solutions, Inc.
Radiology · 28d
Cleared Jul 12, 2017
OEC Elite MiniView
K171800 · OXO
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 26d