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

Filters: Cleared only ×
175,820 results
24193–24216 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 2018
EVOLUX CAD/CAM PMMA BLOCKS
K182065 · EBG
Blue Dent Dental
Dental · 134d
Cleared Dec 13, 2018
Erran Dental Zirconia
K182068 · EIH
Hangzhou Erran Technology Co., Ltd.
Dental · 134d
Cleared Dec 13, 2018
neoBLUE blanket LED Phototherapy System
K182178 · LBI
Natus Medical Incorporated
General Hospital · 122d
Cleared Dec 13, 2018
HipCheck
K182359 · LLZ
Stryker Corp.
Radiology · 105d
Cleared Dec 13, 2018
Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
K182397 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 100d
Cleared Dec 13, 2018
LaparoGuard
K182434 · GCJ
Mariner Endosurgery, Inc.
General & Plastic Surgery · 98d
Cleared Dec 13, 2018
StatStrip Xpress 2 Glucose Hospital Meter System
K182549 · PZI
Nova Biomedical Corporation
Chemistry · 87d
Cleared Dec 13, 2018
StatStrip Xpress Glucose Hospital Meter System
K182552 · PZI
Nova Biomedical Corporation
Chemistry · 87d
Cleared Dec 13, 2018
IlluminOss Photodynamic Bone Stabilization System
K183145 · QAD
Illuminoss Medical, Inc.
Orthopedic · 30d
Cleared Dec 13, 2018
Selectra Catheters, Selectra Accessory Kit
K183265 · DQY
Biotronik, Inc.
Cardiovascular · 20d
Cleared Dec 12, 2018
Harvest Dental Polymer Blocks
K180578 · EBG
Harvest Dental Products, LLC
Dental · 282d
Cleared Dec 12, 2018
On1 Universal Abutment
K181869 · NHA
Nobel Biocare AB
Dental · 153d
Cleared Dec 12, 2018
LEUCADIA AUTOLOK™ Pedicle Screw System
K182339 · NKB
Clearview Orthopedic Development, LLC
Orthopedic · 106d
Cleared Dec 12, 2018
PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK...
K182473 · KWQ
K2m, Inc.
Orthopedic · 93d
Cleared Dec 12, 2018
Medline Cautery Electrode (SILICONE)
K182812 · GEI
Medline Industries, Inc.
General & Plastic Surgery · 70d
Cleared Dec 12, 2018
Salvo™ Spine System
K182954 · NKB
Spine Wave, Inc.
Orthopedic · 49d
Cleared CT Dec 12, 2018
enlighten III Laser System
K182997 · GEX
Cutera, Inc.
General & Plastic Surgery · 43d
Cleared Dec 12, 2018
EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping...
K183128 · DQK
Abbott
Cardiovascular · 29d
Cleared Dec 12, 2018
ANAX™ OCT Spinal System
K183383 · NKG
U&I Corporation
Orthopedic · 6d
Cleared Dec 11, 2018
Mygen V-1000 RF System
K180999 · GEI
RF Medical Co., Ltd.
General & Plastic Surgery · 239d
Cleared Dec 11, 2018
Cardinal Health Sterilization Wrap
K181174 · FRG
Cardinal Health200, LLC
General Hospital · 223d
Cleared Dec 11, 2018
Life Spine Resolute™ Threaded Cage System
K181625 · MAX
Life Spine, Inc.
Orthopedic · 174d
Cleared Dec 11, 2018
BI-MENTUM dual mobility system
K181744 · LZO
Serf
Orthopedic · 162d
Cleared Dec 11, 2018
Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens...
K181920 · LPL
CooperVision, Inc.
Ophthalmic · 146d