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
17521–17544 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 2021
Piccolo Medical SmartPICC System
K200037 · LJS
Piccolo Medical, Inc.
Cardiovascular · 380d
Cleared Jan 22, 2021
ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue...
K201066 · GEI
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 275d
Cleared Jan 22, 2021
Simply Iconic Implants
K201553 · DZE
Implant Direct Sybron Manufacturing, LLC
Dental · 226d
Cleared Jan 22, 2021
ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue...
K201696 · GEI
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 214d
Cleared Jan 22, 2021
NuFace Trinity Plus Device
K201782 · NFO
Carol Cole Company Dba Nuface
Neurology · 206d
Cleared Jan 22, 2021
VirtueRF
K202415 · GEI
ShenB Co., Ltd.
General & Plastic Surgery · 151d
Cleared Jan 22, 2021
ClearPoint Array System
K202575 · HAW
ClearPoint Neuro, Inc.
Neurology · 140d
Cleared Jan 22, 2021
Surgical Mask
K202640 · FXX
Jiangsu Medpure Biological Technology...
General Hospital · 133d
Cleared Jan 22, 2021
SPRINT PNS System
K202660 · NHI
Spr Therapeutics, Inc.
Neurology · 130d
Cleared Jan 22, 2021
BRIUS Clear Aligners
K202792 · NXC
Brius Technologies, Inc.
Dental · 122d
Cleared Jan 22, 2021
Flex-ThreadTM Distal Fibula Intramedullary Nail System
K202858 · HSB
Conventus Orthopaedics, LLC
Orthopedic · 116d
Cleared Jan 22, 2021
Platinum dRF Imaging System
K203010 · JAA
Apelem-Dms Group
Radiology · 113d
Cleared Jan 22, 2021
EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000...
K203131 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 95d
Cleared Jan 22, 2021
Nerivio, FGD000075-4.7
K203181 · QGT
Theranica Bioelectronics , Ltd.
Neurology · 88d
Cleared Jan 22, 2021
Advanced Research Medical Trident SI Screw System
K203373 · OUR
Advanced Research Medical, LLC
Orthopedic · 67d
Cleared Jan 22, 2021
Non-Contact Forehead Thermometer (UT30H)
K203656 · FLL
Uni-Trend Technology (China) Co., Ltd.
General Hospital · 38d
Cleared Jan 21, 2021
pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK...
K200731 · NUC
Pjur Group Luxembourg S.A.
Obstetrics & Gynecology · 307d
Cleared Jan 21, 2021
Forwarts
K201366 · GEH
Pronova Laboratories BV
General & Plastic Surgery · 244d
Cleared Jan 21, 2021
EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III...
K201758 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 206d
Cleared Jan 21, 2021
DIR 800
K202391 · IZI
Aesculap, Inc.
Neurology · 153d
Cleared Jan 21, 2021
cobas CTNG for use on cobas 6800/8800 systems
K202408 · QEP
Roche Molecular Systems, Inc.
Microbiology · 153d
Cleared Jan 21, 2021
EEA Circular Stapler with Tri-Staple Technology
K202507 · GDW
Covidien
General & Plastic Surgery · 143d
Cleared Jan 21, 2021
Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask
K202595 · FXX
Premier Guard USA, LLC
General Hospital · 135d
Cleared Jan 21, 2021
Precision Delivery Infusion Set
K202672 · FPA
Quest Medical, Inc.
General Hospital · 128d