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
11065–11088 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 21, 2023
OIC Variable Angle Small Fragment Locking Plate System
K223118 · HRS
Orthopaedic Implant Company
Orthopedic · 110d
Cleared Jan 21, 2023
VX1+
K223516 · DQK
Volta Medical
Cardiovascular · 60d
Cleared Jan 20, 2023
Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle
K203792 · FMI
Pikdare Spa
General Hospital · 753d
Cleared Jan 20, 2023
Digital Thermometer, Model: DT007, DT008
K214077 · FLL
Guangzhou Berrcom Medical Device Co.,...
General Hospital · 389d
Cleared Jan 20, 2023
TD-5010 Lancing Device and TD-5084 Sterile Lancets
K221419 · QRL
Gostar Co., Ltd.
General & Plastic Surgery · 249d
Cleared Jan 20, 2023
CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS...
K221683 · FAJ
Olympus Medical Systems Corporation
Gastroenterology & Urology · 224d
Cleared Jan 20, 2023
Advanced MyHip Planner
K221725 · LLZ
Medacta International S.A.
Radiology · 220d
Cleared Jan 20, 2023
The Sensititre YeastOne Susceptibility System with Caspofungin in the...
K221899 · NGZ
Thermo Fisher Scientific
Microbiology · 204d
Cleared Jan 20, 2023
Capiflo 5001
K222158 · JOW
K&L Distributing, Inc.
Cardiovascular · 184d
Cleared Jan 20, 2023
Semi-automatic Biopsy-Needle (BIM 18/20)
K222462 · KNW
Itp Innovative Tomography Products GmbH
General & Plastic Surgery · 158d
Cleared Jan 20, 2023
Blueprint Mixed Reality system
K222510 · OLO
Tornier S.A.S.
Orthopedic · 154d
Cleared Jan 20, 2023
pRESET Thrombectomy Device
K222848 · POL
Phenox Limited
Neurology · 121d
Cleared Jan 20, 2023
FlowArt® Needle-Free Split Septum Valve
K222889 · FPA
Asset Medikal Tasarim San Tic As.
General Hospital · 119d
Cleared Jan 20, 2023
Highlander™ 014 PTA Balloon Dilatation Catheter
K223177 · LIT
C.R. Bard, Inc.
Cardiovascular · 101d
Cleared Jan 20, 2023
Duetto Suprema
K223404 · GEX
Quanta System Spa
General & Plastic Surgery · 72d
Cleared Jan 20, 2023
ZESPIN SI Joint Fusion System
K223521 · OUR
Aegis Spine, Inc.
Orthopedic · 58d
Cleared Jan 20, 2023
Triathlon® Hinge Knee System
K223528 · KRO
Howmedica Osteonics Corp., Dba...
Orthopedic · 58d
Cleared Jan 20, 2023
GMK Sphere & GMK SpheriKA Cementless
K223548 · MBH
Medacta International S.A.
Orthopedic · 56d
Cleared Jan 20, 2023
DRX - Compass
K223842 · KPR
Carestream Health, Inc.
Radiology · 29d
Cleared Jan 19, 2023
Disposable Endoscopic Cutter Stapler and Cartridge
K211197 · GDW
Changzhou Waston Medical Appliance...
General & Plastic Surgery · 638d
Cleared Jan 19, 2023
No Stress Impress
K213175 · ELW
No Stress Impress, LLC
Dental · 478d
Cleared Jan 19, 2023
LM-9300 Plus Lithotripter
K213772 · LNS
Lite-Med, Inc.
Gastroenterology & Urology · 413d
Cleared Jan 19, 2023
Biosci™ Inactivated Transport Medium, Biosci™ ITM
K220059 · QBD
Shenzhen Dakewe Bio-Engineering Co.,...
Microbiology · 374d
Cleared Jan 19, 2023
Disposable Non-invasive EEG Sensor
K220448 · GXY
Shenzhen Med-Link Electronics Tech...
Neurology · 337d