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
29257–29280 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 28, 2017
RFID Localization System- Localizer Reader, RFID Localization System-...
K163667 · PBY
Health Beacons, Inc.
General & Plastic Surgery · 122d
Cleared Apr 28, 2017
VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles
K170070 · FRC
STERIS Corporation
General Hospital · 109d
Cleared Apr 28, 2017
Z-DOSE29
K170273 · JAK
Zetta Medical Technologies, LLC
Radiology · 88d
Cleared Apr 28, 2017
Smith & Nephew SURESHOT Distal Targeting System V4.0
K170280 · OLO
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Apr 28, 2017
van Andel Dilatation Catheter
K170616 · DRE
Cook Incorporated
Cardiovascular · 58d
Cleared Apr 28, 2017
ABL90 FLEX, ABL90 FLEX PLUS
K170882 · MQM
Radiometer Medical Aps
Chemistry · 35d
Cleared Apr 28, 2017
BrainPulse 1100
K170926 · POP
Jan Medical, Inc.
Neurology · 30d
Cleared Apr 28, 2017
Biodesign Staple Line Reinforcement
K170945 · OXE
Cook Biotech Incorporated
General & Plastic Surgery · 29d
Cleared Apr 28, 2017
CardioCel 3D
K170951 · PSQ
Admedus Regen Pty, Ltd.
Cardiovascular · 28d
Cleared Apr 28, 2017
syngo.CT View&GO
K170952 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 28d