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
20377–20400 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 06, 2020
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
K200023 · LSR
Gold Standard Diagnostics
Microbiology · 91d
Cleared Apr 06, 2020
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
K200025 · LSR
Gold Standard Diagnostics
Microbiology · 91d
Cleared Apr 06, 2020
ADVIA Centaur CA 125II
K200199 · LTK
Siemens Healthcare Diagnostics, Inc.
Immunology · 70d
Cleared Apr 06, 2020
Stat Profile Prime Plus Analyzer System
K200204 · GGZ
Nova Biomedical Corporation
Chemistry · 69d
Cleared Apr 06, 2020
MTS Lefamulin 0.016- 256 µg/mL
K200308 · JWY
Liofilchem S. R. 1.
Microbiology · 60d
Cleared Apr 06, 2020
Tryptik Ti
K200312 · ODP
Spineart
Orthopedic · 60d
Cleared Apr 06, 2020
Akros Scruture Anchor LisFranc Repair Kit
K200361 · HTN
Akros Medical
Orthopedic · 52d
Cleared Apr 06, 2020
ClearMask Transparent Surgical Face Mask
K200576 · FXX
Clearmask, LLC
General Hospital · 32d
Cleared Apr 06, 2020
Eko CORE
K200776 · DQD
Eko Devices, Inc.
Cardiovascular · 12d
Cleared Apr 03, 2020
Faico Dental Implant System
K192015 · DZE
Faico Medical, LLC
Dental · 249d
Cleared Apr 03, 2020
Osom Ultra Plus Flu A&B Test Kit
K192719 · PSZ
SEKISUI Diagnostics, LLC
Microbiology · 190d
Cleared Apr 03, 2020
Diode Laser Hair Removal Machine
K192735 · GEX
Beijing Lead Beauty S & T Co., Ltd.
General & Plastic Surgery · 189d
Cleared Apr 03, 2020
Visera Elite II Video System Center, Visera Elite II Endoeye 3D
K193026 · GCJ
Olympus Medical Systems Corp.
Obstetrics & Gynecology · 156d
Cleared Apr 03, 2020
FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System
K200022 · OWB
Livermoretech, Inc.
Radiology · 88d
Cleared Apr 03, 2020
Aria System
K200564 · JOW
Inova Labs
Cardiovascular · 30d
Cleared Apr 03, 2020
ADAPT Tissue
K200566 · PSQ
Admedus Regen Pty, Ltd.
Cardiovascular · 30d
Cleared Apr 03, 2020
RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single...
K200577 · NVE
STERIS Corporation
General Hospital · 29d
Cleared Apr 03, 2020
Eclipse Treatment Planning System v16.0
K200608 · MUJ
Varian Medical Systems, Inc.
Radiology · 25d
Cleared Apr 03, 2020
LAP-iX Suction Irrigation
K200638 · HET
Sejong Medical Co., Ltd.
General & Plastic Surgery · 24d
Cleared Apr 02, 2020
SIRION Lateral Lumbar Interbody System
K192006 · MAX
Astura Medical, LLC
Orthopedic · 248d
Cleared Apr 02, 2020
MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle,...
K192099 · KNW
Medax Srl Unipersonale
General & Plastic Surgery · 241d
Cleared Apr 02, 2020
Medone Ultra, Medextra
K192101 · KNW
Medax Srl Unipersonale
General & Plastic Surgery · 241d
Cleared Apr 02, 2020
IntelePACS
K192176 · LLZ
Intelerad Medical Systems Incorporated
Radiology · 234d
Cleared Apr 02, 2020
QwikCheck Chemical Indicators
K192445 · JOJ
Serim Research Corporation
General Hospital · 209d