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
20377–20400 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 27, 2020
Xenocor Articulating Xenoscope Laparoscope
K193315 · GCJ
Xenocor, Inc.
General & Plastic Surgery · 59d
Cleared Jan 27, 2020
M.U.S.T. Pedicle Screw System
K193365 · NKB
Medacta International S.A.
Orthopedic · 54d
Cleared Jan 26, 2020
Emission Computed Tomography System
K193241 · KPS
Shanghai United Imaging Healthcare...
Radiology · 62d
Cleared Jan 26, 2020
THD Procto Software System
K193512 · IYO
Thd Spa
Radiology · 39d
Cleared Jan 25, 2020
Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative...
K191186 · GYC
Ad-Tech Medical Instrument Corporation
Neurology · 267d
Cleared Jan 24, 2020
Cellvizio 100 Series System with Confocal Miniprobes
K191144 · OWN
Mauna Kea Technologies
General & Plastic Surgery · 269d
Cleared Jan 24, 2020
Paratrooper Plantar Plate Repair System
K191227 · MBI
Paragon 28, Inc.
Orthopedic · 262d
Cleared Jan 24, 2020
CARESCAPE B450
K191249 · MHX
GE Healthcare Finland Oy
Cardiovascular · 260d
Cleared Jan 24, 2020
LCCS VC-S RF Cannula
K191293 · GXI
Lccs Products Limited
Neurology · 255d
Cleared Jan 24, 2020
KardiaMobile, KardiaStation
K191406 · DXH
AliveCor, Inc.
Cardiovascular · 241d
Cleared Jan 24, 2020
cortiQ PRO
K191432 · OLU
G.Tec Medical Engineering GmbH
Neurology · 240d
Cleared Jan 24, 2020
SYPMHONY™ OCT System
K192014 · NKG
Medos International SARL
Orthopedic · 179d
Cleared Jan 24, 2020
Blue Nitrile Examination Gloves Powder Free
K192333 · LZA
Jr Engineering & Medical Technologies...
General Hospital · 150d
Cleared Jan 24, 2020
BD Cathena (TM) Safety IV Catheter
K192493 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 135d
Cleared Jan 24, 2020
CMOS Video Esophagoscope SSU
K192523 · EOX
Karl Storz SE & CO. KG
Ear, Nose, Throat · 133d
Cleared Jan 24, 2020
Disposable SpO2 Sensor
K192608 · DQA
Shenzhen Sino-K Medical Technology...
Anesthesiology · 126d
Cleared Jan 24, 2020
Gemini Titan Sterilization Wrap
K192641 · FRG
Medline Industries, Inc.
General Hospital · 122d
Cleared Jan 24, 2020
CareSens S Clear BT Blood Glucose Monitoring System
K192859 · NBW
I-Sens, Inc.
Chemistry · 112d
Cleared Jan 24, 2020
APTUS Clavicle System
K192984 · HRS
Medartis AG
Orthopedic · 91d
Cleared Jan 24, 2020
MRCAT brain
K193109 · MUJ
Philips Medical Systems MR Finland
Radiology · 77d
Cleared Jan 24, 2020
Persona Personalized Knee System
K193223 · JWH
Zimmer, Inc.
Orthopedic · 63d
Cleared Jan 24, 2020
Stat Profile Prime Plus Analyzer System
K193246 · CHL
Nova Biomedical Corporation
Chemistry · 60d
Cleared Jan 24, 2020
FlightPlan for Embolization
K193261 · LLZ
GE Medical Systems SCS
Radiology · 59d
Cleared Jan 24, 2020
Reprocessed Achieve Catheter Connecting Cable
K193263 · NLH
Innovative Health, LLC
Cardiovascular · 59d