FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
28657–28680 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 2017
CAPTIVATE™ Compression Screws
K162825 · HWC
Globus Medical, Inc.
Orthopedic · 206d
Cleared May 01, 2017
NaviSuite SSI Edition
K163119 · LLZ
Medcom GmbH
Radiology · 174d
Cleared May 01, 2017
NuVasive CoRoent Ti-C System
K163707 · MAX
Nu Vasive, Incorporated
Orthopedic · 123d
Cleared May 01, 2017
StealthStation S8 Spine Software v1.0.0
K170011 · OLO
Medtronic Navigation
Orthopedic · 118d
Cleared May 01, 2017
MagVita TMS Therapy - w/MagPro R20
K170114 · OBP
Tonica Elektronik A/S
Neurology · 109d
Cleared May 01, 2017
IontoDC
K170291 · EGJ
Soterix Medical, Inc.
Physical Medicine · 90d
Cleared May 01, 2017
VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle,...
K170294 · FTL
C. R. Bard
General & Plastic Surgery · 90d
Cleared May 01, 2017
XSTAT 30, 3-Pack
K170334 · PGZ
Revmedx, Inc.
General & Plastic Surgery · 88d
Cleared May 01, 2017
ScanX Intraoral View
K170733 · MUH
Duerr Dental AG
Radiology · 52d
Cleared May 01, 2017
Bovie J-Plasma Precise FLEX Handpiece
K170777 · GEI
Bovie Medical Corporation
General & Plastic Surgery · 47d
Cleared May 01, 2017
Televere Digital Imaging System
K170975 · MQB
Televere Systems
Radiology · 28d
Cleared Apr 29, 2017
Digital TENS Unit
K170145 · NUH
Shenzhen Eapply Technology Co., Ltd.
Neurology · 102d
Cleared Apr 28, 2017
Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters
K161596 · DQO
AngioDynamics, Inc.
Cardiovascular · 323d
Cleared Apr 28, 2017
Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)
K161724 · IYE
Radiomed Corporation
Radiology · 310d
Cleared Apr 28, 2017
Salvin Tenting Screw System
K161857 · DZL
Salvin Dental Specialties
Dental · 296d
Cleared Apr 28, 2017
Scope-Assist Flushing Sink
K162120 · FEB
Custom Ultrasonics, Inc.
General Hospital · 270d
Cleared Apr 28, 2017
VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing
K162159 · OMP
Vr Medical Technologies, LLC
General & Plastic Surgery · 269d
Cleared Apr 28, 2017
Randox RX Daytona Plus Magnesium (MG)
K162200 · JGJ
Randox Laboratories, Ltd.
Chemistry · 266d
Cleared Apr 28, 2017
Self Sealing Sterilization Pouches
K162258 · FRG
Tianchang Jiarui Packaging Material...
General Hospital · 260d
Cleared Apr 28, 2017
BabyDance Fertility Lubricant
K162319 · PEB
Fairhaven Health, LLC
Obstetrics & Gynecology · 252d
Cleared Apr 28, 2017
WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts
K162460 · GXY
Wavi Co.
Neurology · 238d
Cleared Apr 28, 2017
IOB Temperature Management System
K162679 · DWJ
Iob Medical, Inc.
Cardiovascular · 214d
Cleared Apr 28, 2017
VERIFY ASSERT STEAM Process Challenge Device
K162945 · OWP
STERIS Corporation
General Hospital · 189d
Cleared Apr 28, 2017
Introcan Safety 3 Closed IV Catheter
K163358 · FOZ
B.Braun Melsungen AG
General Hospital · 149d