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
17929–17952 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 18, 2021
4CIS SARA Spine System, 4CIS VERTU Spine System
K202498 · NKB
Solco Biomedical Company India...
Orthopedic · 171d
Cleared Feb 18, 2021
LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus
K202573 · LSR
DiaSorin, Inc.
Microbiology · 167d
Cleared Feb 18, 2021
LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus
K202574 · LSR
DiaSorin, Inc.
Microbiology · 167d
Cleared Feb 18, 2021
Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60
K202687 · FLL
Shenzhen Lepu Intelligent Medical...
General Hospital · 156d
Cleared Feb 18, 2021
Surgical Face Mask (non-sterile)
K203426 · FXX
Nantong Taiweishi Medical Technology...
General Hospital · 90d
Cleared Feb 18, 2021
PhantomMSK Hip
K210136 · LLZ
OrthoGrid Systems, Inc.
Radiology · 30d
Cleared Feb 18, 2021
EsoCheck Cell Collection Device
K210137 · EOX
Lucid Diagnostics, Inc.
Gastroenterology & Urology · 30d
Cleared Feb 18, 2021
Green X 18(Model : PHT-75CHS)
K210329 · OAS
VATECH Co., Ltd.
Radiology · 14d
Cleared Feb 17, 2021
SpaceFlex Shoulder
K202338 · MBB
G21, S.R.L.
Orthopedic · 184d
Cleared Feb 17, 2021
Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling...
K202401 · KGO
Eco Medi Glove Sdn. Bhd.
General Hospital · 180d
Cleared Feb 17, 2021
VIOLA
K203307 · DXC
Vascular Graft Solutions, Ltd.
Cardiovascular · 100d
Cleared Feb 17, 2021
FITBONE(R) TAA
K203399 · HSB
Wittenstein Intens GmbH
Orthopedic · 90d
Cleared Feb 17, 2021
s-Clean SQ-SL Implant System Regular
K210132 · DZE
Dentis Co., Ltd.
Dental · 29d
Cleared Feb 17, 2021
iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal...
K210252 · JWH
Conformis, Inc.
Orthopedic · 19d
Cleared Feb 16, 2021
VesselIQ Xpress
K200626 · JAK
GE Medical Systems SCS
Radiology · 343d
Cleared Feb 16, 2021
Easytech® Anatomical Shoulder System
K201391 · PKC
Fx Shoulder USA, Inc.
Orthopedic · 265d
Cleared Feb 16, 2021
Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal...
K201732 · FXX
Dukal Corporation
General Hospital · 236d
Cleared Feb 16, 2021
Vitrea Software Package, VSTP-001A
K203312 · LLZ
Canon Medical Systems Corporation
Radiology · 98d
Cleared CT Feb 16, 2021
Relivion
K203419 · PCC
Neurolief , Ltd.
Neurology · 89d
Cleared Feb 16, 2021
Extra Large Check-Flo Introducer
K203670 · DYB
Cook Incorporated
Cardiovascular · 62d
Cleared Feb 16, 2021
ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System,...
K210035 · OUR
Aegis Spine
Orthopedic · 41d
Cleared Feb 16, 2021
Rebar Micro Catheter
K210114 · KRA
Micro Therapeuatics, Inc. D/B/A Ev3...
Neurology · 28d
Cleared Feb 16, 2021
cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System
K210234 · OCC
Roche Molecular Systems, Inc.
Microbiology · 19d
Cleared Feb 16, 2021
PLPT LDV (Low Dead Volume) Sterile Syringe
K210443 · QNQ
Poonglim Pharmatech, Inc.
General Hospital