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
26305–26328 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 23, 2018
ARROW Reverse Porous Glenoid
K171789 · PHX
Fournitures Hospitalieres Industrie
Orthopedic · 222d
Cleared Jan 23, 2018
TruAbutment DS
K172304 · NHA
Truabutment, Inc.
Dental · 176d
Cleared Jan 23, 2018
gammaCore-S
K173442 · PKR
Electrocore, LLC
Neurology · 78d
Cleared Jan 22, 2018
Kit Boxes and Kit Plates
K163600 · KCT
Nobel Biocare AB
General Hospital · 397d
Cleared Jan 22, 2018
FortiCore®
K171312 · MAX
Nanovis, LLC
Orthopedic · 263d
Cleared Jan 22, 2018
CONTEC™ Electrocardiograph
K171360 · DPS
Contec Medical Systems Co.,Ltd
Cardiovascular · 258d
Cleared Jan 22, 2018
3D APT
K172920 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 119d
Cleared Jan 22, 2018
CAMPYLOBACTER QUIK CHEK
K173217 · LQP
Techlab, Inc.
Microbiology · 111d
Cleared Jan 22, 2018
CAMPYLOBACTER CHEK
K173219 · LQP
Techlab, Inc.
Microbiology · 111d
Cleared Jan 22, 2018
Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm,...
K173235 · DQX
Scientia Vascular, LLC
Cardiovascular · 109d
Cleared Jan 22, 2018
EZ Plate
K173306 · KWQ
Zavation Medical Products, LLC
Orthopedic · 96d
Cleared Jan 22, 2018
3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M...
K173584 · FRC
3M Company
General Hospital · 63d
Cleared Jan 22, 2018
Centurion POCT System
K180025 · NKG
Orthofix, Inc.
Orthopedic · 19d
Cleared Jan 19, 2018
Fiji Anchor
K171228 · MAI
Sportwelding GmbH
Orthopedic · 268d
Cleared Jan 19, 2018
LINK® BiMobile(TM) Dual Mobility System
K171273 · MEH
Waldemar Link GmbH & Co. KG
Orthopedic · 263d
Cleared Jan 19, 2018
FUJIFILM Bronchoscope Model EB-530P
K171291 · EOQ
Fujifilm Medical Systems U.S.A, Inc.
Ear, Nose, Throat · 262d
Cleared Jan 19, 2018
EM-4000 Specular Microscope
K171313 · NQE
Tomey Corporation
Ophthalmic · 260d
Cleared Jan 19, 2018
Focus Cap
K171673 · FDF
Gce Medical Corporation
Gastroenterology & Urology · 227d
Cleared Jan 19, 2018
Angel Align System
K171674 · NXC
Smile Development Corp
Dental · 227d
Cleared Jan 19, 2018
KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
K171731 · OIF
Kronus, Inc.
Chemistry · 221d
Cleared Jan 19, 2018
Straumann Dental Implant System
K171784 · DZE
Straumann USA, LLC
Dental · 218d
Cleared Jan 19, 2018
ReddyPort NIV Access Elbow
K171827 · MNS
Smd Manufacturing, LLC
Anesthesiology · 213d
Cleared Jan 19, 2018
FORZA® XP Expandable Spacer System
K172696 · MAX
Orthofix, Inc.
Orthopedic · 134d
Cleared Jan 19, 2018
DRI OCT Triton
K173119 · OBO
Topcon Corporation
Ophthalmic · 112d