FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
12625–12648 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 2022
OsteoCentric Spine MIS Pedicle Fastener System
K221332 · NKB
OsteoCentric Technologies
Orthopedic · 80d
Cleared Jul 28, 2022
Gastrointestinal Boundary Identifier (GIBI HD)
K221898 · KNT
Reshape Lifesciences
Gastroenterology & Urology · 28d
Cleared Jul 28, 2022
INERTIA CONNEXX Modular Pedicle Screw System
K221905 · NKB
Nexxt Spine, LLC
Orthopedic · 28d
Cleared Jul 28, 2022
Trinias
K221922 · OWB
Shimadzu Corporation Medical Systems...
Radiology · 27d
Cleared Jul 28, 2022
Swoop Portable MR Imaging System
K221923 · LNH
Hyperfine, Inc.
Radiology · 27d
Cleared Jul 28, 2022
Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER...
K221945 · GEI
Conmed Corporation
General & Plastic Surgery · 23d
Cleared Jul 28, 2022
EXALT Model B Single-Use Bronchoscope
K222014 · EOQ
Boston Scientific Corporation
Ear, Nose, Throat · 20d
Cleared Jul 28, 2022
Biotres
K222017 · MWJ
Biotricity
Cardiovascular · 20d
Cleared Jul 27, 2022
DeepRhythmAI
K210822 · DQK
Medicalgorithmics S.A.
Cardiovascular · 495d
Cleared Jul 27, 2022
EliA Ro52, EliA Ro60
K210902 · LKJ
Phadia AB
Immunology · 488d
Cleared Jul 27, 2022
KeriFlex® MCP and PIP Finger Joint Prostheses
K211385 · KYJ
Keri Medical SA
Orthopedic · 449d
Cleared Jul 27, 2022
TransLoc 3D
K211496 · OUR
Foundation Fusion Solutions, LLC (Dba...
Orthopedic · 440d
Cleared Jul 27, 2022
Dornier Thulio
K213252 · GEX
Dornier Medtech America, Inc.
Gastroenterology & Urology · 300d
Cleared Jul 27, 2022
AquaA
K213507 · FIP
Fresenius Medical Care Rental...
Gastroenterology & Urology · 268d
Cleared Jul 27, 2022
HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap
K214007 · FRG
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 217d
Cleared Jul 27, 2022
AOK 95A Medical Mask (20200049)
K220876 · FXX
Aok Tooling Limited
General Hospital · 124d
Cleared Jul 27, 2022
Upper Arm Type Blood Pressure Monitor
K220886 · DXN
Shenzhen Jamr Technology Co., Ltd.
Cardiovascular · 121d
Cleared Jul 27, 2022
Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound...
K220922 · PFO
Cochlear Americas
Ear, Nose, Throat · 118d
Cleared Jul 27, 2022
Real Intelligence Cori
K220958 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 117d
Cleared Jul 27, 2022
Hummingbird Tympanostomy Tube System
K221254 · ETD
Preceptis Medical, Inc.
Ear, Nose, Throat · 86d
Cleared Jul 27, 2022
Powder Free Nitrile Examination Gloves (Blue),Tested for Use with...
K221269 · LZA
Better Care Plastic Technology Co., Ltd.
General Hospital · 86d
Cleared Jul 27, 2022
Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with...
K221271 · LZA
Shandong Maida Medical Technology...
General Hospital · 86d
Cleared Jul 27, 2022
reVive Light Therapy LED Cleansing System
K221430 · OHS
Led Technologies, Inc.
General & Plastic Surgery · 71d
Cleared Jul 27, 2022
CorPath GRX System
K221464 · DXX
Corindus, Inc.
Cardiovascular · 69d