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
27289–27312 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 06, 2017
Boundary Anterior Lumbar Buttress Plate
K173091 · KWQ
Nvision Biomedical Technologies, LLC
Orthopedic · 68d
Cleared Dec 06, 2017
Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System
K173153 · MAX
Nu Vasive, Incorporated
Orthopedic · 68d
Cleared Dec 05, 2017
OxyPure Color Silicone Hydrogel Soft Contact Lenses
K171447 · LPL
Visco Vision, Inc.
Ophthalmic · 203d
Cleared CT Dec 05, 2017
Vivaer ARC Stylus
K172529 · GEI
Aerin Medical, Inc.
General & Plastic Surgery · 106d
Cleared Dec 05, 2017
Disposable Circular Stapler
K172561 · GDW
Changzhou Kangdi Medical Stapler Co.,...
General & Plastic Surgery · 102d
Cleared Dec 05, 2017
SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4...
K172618 · GCJ
Olympus Medical Systems Corp.
General & Plastic Surgery · 96d
Cleared Dec 05, 2017
Renamel Microfill
K172707 · EBF
Cosmedent, Inc.
Dental · 88d
Cleared Dec 05, 2017
P20 Series Digital Color Doppler Ultrasound System
K172993 · IYN
Sonoscape Medical Corp.
Radiology · 69d
Cleared Dec 05, 2017
Arisstos™ Spinal System
K173126 · NKB
Ingenium Spine
Orthopedic · 67d
Cleared Dec 04, 2017
ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay
K171771 · PDJ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 173d
Cleared Dec 04, 2017
PhotoFix Decellularized Bovine Pericardium
K172085 · PSQ
Cryolife, Inc.
Cardiovascular · 146d
Cleared Dec 04, 2017
Velofix™ TLIF Cage
K172419 · MAX
U&I Corporation
Orthopedic · 116d
Cleared Dec 04, 2017
Panther Fusion AdV/hMPV/RV Assay
K172629 · OCC
Hologic, Inc.
Microbiology · 94d
Cleared Dec 04, 2017
PowerDot PD-01M
K172876 · NGX
Smartmissimo Technologies Pte, Ltd.
Physical Medicine · 74d
Cleared Dec 04, 2017
SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura,...
K173260 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 55d
Cleared Dec 04, 2017
ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath
K173470 · QEW
Inari Medical
Cardiovascular · 26d
Cleared Dec 04, 2017
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
K173538 · LRX
Alcon Laboratories, Inc.
Ophthalmic · 19d
Cleared Dec 01, 2017
S.I.N. Implant System
K170392 · DZE
S.I.N. ? Sistema DE Implante Nacional...
Dental · 296d
Cleared Dec 01, 2017
Altus Spine Interbody Fusion System
K170553 · MAX
Altus Partners, LLC
Orthopedic · 280d
Cleared Dec 01, 2017
IR Type Implant System
K171185 · DZE
Biotem Co., Ltd.
Dental · 221d
Cleared Dec 01, 2017
EZFluence
K171352 · IYE
Radformation, Inc.
Radiology · 206d
Cleared Dec 01, 2017
Straumann n!ce Glass Ceramic A14 Blocks
K171773 · NHA
Institut Straumann AG
Dental · 170d
Cleared Dec 01, 2017
Alevicyn SG Antimicrobial Gel
K171935 · FRO
Sonoma Pharmaceuticals, Inc.
General & Plastic Surgery · 156d
Cleared Dec 01, 2017
ARIX Humerus System
K172008 · HRS
Jeil Medical Corporation
Orthopedic · 151d