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
19009–19032 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 2020
myQA iON
K201798 · LHN
Iba Dosimetry GmbH
Radiology · 17d
Cleared Jul 16, 2020
ZCA All-Poly Acetabular Cups
K191449 · JDI
Zimmer, Inc.
Orthopedic · 412d
Cleared Jul 16, 2020
TiN Coated Humeral Head
K191698 · KWT
Fx Shoulder USA, Inc.
Orthopedic · 387d
Cleared Jul 16, 2020
KeraStat Cream
K192386 · KGN
Keranetics
General & Plastic Surgery · 317d
Cleared Jul 16, 2020
Arm Blood Pressure Monitor
K193456 · DXN
Ningbo Ranor Medical Science &...
Cardiovascular · 216d
Cleared Jul 16, 2020
Vivid S60N, Vivid S70N
K200497 · IYN
GE Medical Systems Ultrasound and...
Radiology · 139d
Cleared Jul 16, 2020
Infrared Thermometer Model Number RN-50A,RN-50B
K200578 · FLL
Ningbo Ranor Medical Science &...
General Hospital · 133d
Cleared Jul 16, 2020
FibroScan® 630
K200655 · IYO
Echosens
Radiology · 126d
Cleared Jul 16, 2020
HealthMammo
K200905 · QFM
Zebra Medical Vision, Ltd.
Radiology · 101d
Cleared Jul 16, 2020
Geneva
K201272 · JAQ
Nucletron B.V.
Radiology · 65d
Cleared Jul 16, 2020
KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular...
K201660 · OQG
Kyocera Medical Technologies, Inc.
Orthopedic · 28d
Cleared Jul 16, 2020
REDUCT® Headless Compression Screw System
K201662 · HWC
Skeletal Dynamics, Inc.
Orthopedic · 27d
Cleared Jul 16, 2020
AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
K201663 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 27d
Cleared Jul 16, 2020
Barricaid Instrument Tray
K201676 · QHG
Intrinsic Therapeutics, Inc.
Orthopedic · 27d
Cleared Jul 15, 2020
Humelock TiN Coated Glenosphere
K191146 · PHX
Fx Shoulder USA, Inc.
Orthopedic · 442d
Cleared Jul 15, 2020
iHealth Infrared No-Touch Forehead Thermometer
K200531 · FLL
Andon Health Co, Ltd.
General Hospital · 135d
Cleared Jul 15, 2020
LifeSignals ECG Remote Monitoring Patch Platform
K200690 · DRG
Lifesignals, Inc.
Cardiovascular · 121d
Cleared Jul 15, 2020
FullFocus
K201005 · QKQ
Paige.Ai, Inc.
Pathology · 90d
Cleared Jul 15, 2020
Encision AEM enTouch 2X Scissor
K201018 · GEI
Encision, Inc.
General & Plastic Surgery · 89d
Cleared Jul 15, 2020
V30 System, V20 System, V10 System, V-FR Handpiece
K201064 · PBX
Viora , Ltd.
General & Plastic Surgery · 85d
Cleared Jul 15, 2020
Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens,...
K201080 · LPL
Visco Vision, Inc.
Ophthalmic · 84d
Cleared Jul 15, 2020
CO2 Laser Therapy System
K201109 · GEX
Shanghai Apolo Medical Technology...
General & Plastic Surgery · 79d
Cleared Jul 15, 2020
CoLink Plating System
K201149 · HRS
In2bones USA, LLC
Orthopedic · 77d
Cleared Jul 15, 2020
BD SoloShot Mini Syringe/ BD Auto Disable Syringe
K201234 · FMF
Becton, Dickinson and Company
General Hospital · 69d