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
19609–19632 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 15, 2020
EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT...
K201605 · MAX
Eit Emerging Implant Technologies GmbH
Orthopedic · 30d
Cleared Jul 15, 2020
TxTiHA IBF System, AxTiHA Stand-Alone ALIF System
K201614 · MAX
Innovasis, Inc.
Orthopedic · 30d
Cleared Jul 15, 2020
Nalu Neurostimulation SCS system
K201618 · GZB
Boston Scientific Neuromodulation
Neurology · 30d
Cleared Jul 15, 2020
Magicore II System
K201621 · NHA
Innobiosurg Co., Ltd.
Dental · 30d
Cleared Jul 14, 2020
EMBOTRAP III Revascularization Device
K193063 · NRY
Neuravi, Ltd.
Neurology · 253d
Cleared Jul 14, 2020
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit...
K193097 · LNH
Canon Medical Systems Corporation
Radiology · 250d
Cleared Jul 14, 2020
Mako Total Knee Application
K193515 · OLO
Mako Surgical Corp.
Orthopedic · 208d
Cleared Jul 14, 2020
Orbit Subretinal Delivery System
K200325 · FMF
Orbit Biomedical
Ophthalmic · 155d
Cleared Jul 13, 2020
TRAUS SUS20
K192561 · DZI
Saeshin Precision Co., Ltd.
Dental · 300d
Cleared Jul 13, 2020
Digiscan FDX
K200218 · OWB
Allengers Medical Systems Limited
Radiology · 167d