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
11881–11904 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 2022
V-Patch Cardiac Monitor
K222842 · DXH
Shandong Corecare Technology Limited
Cardiovascular · 30d
Cleared Oct 20, 2022
Mercu 1717V
K222886 · MQB
Iray Technology Taicang , Ltd.
Radiology · 27d
Cleared Oct 19, 2022
Proximerge 2 Dental Implant System
K211409 · DZE
Quadric Biomed, LLC
Dental · 531d
Cleared Oct 19, 2022
Infinity Pro, Logic, Quality, Sprint
K213742 · EIA
Olsen Ind?stria E Com?rcio S.A.
Dental · 324d
Cleared Oct 19, 2022
Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple
K220992 · LYZ
Ever Global (Vietnam) Enterprise...
General Hospital · 198d
Cleared Oct 19, 2022
PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch
K221029 · PSQ
Synovis Life Technologies, Inc.
Cardiovascular · 195d
Cleared Oct 19, 2022
Vascu-Guard Vascular Repair Patch
K221032 · PSQ
Synovis Life Technologies, Inc.
Cardiovascular · 195d
Cleared Oct 19, 2022
Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System,...
K221728 · KWQ
Stryker Corporation
Orthopedic · 127d
Cleared Oct 19, 2022
STERN FIX Sternal Stabilization System
K221795 · JDQ
Neos Surgery S.L
Orthopedic · 120d
Cleared Oct 19, 2022
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
K222643 · PBY
Sirius Medical Systems B.V.
General & Plastic Surgery · 48d
Cleared Oct 19, 2022
SOMAVAC 100 Sustained Vacuum System
K222856 · BTA
Somavac Medical Solutions, Inc.
General & Plastic Surgery · 28d
Cleared Oct 19, 2022
RADIANCE ULTRA 32 4K ZEROWIRE DUO
K222890 · GCJ
Nds Surgical Imaging, LLC
General & Plastic Surgery · 26d
Cleared Oct 18, 2022
Nova Primary Glucose Analyzer System
K203549 · CGA
Nova Biomedical Corporation
Chemistry · 683d
Cleared Oct 18, 2022
EVOS Wrist Spanning Plate
K213123 · HRS
Smith & Nephew, Inc.
Orthopedic · 386d
Cleared Oct 18, 2022
TELIGEN System
K213978 · HRX
Medos International SARL
Orthopedic · 302d
Cleared Oct 18, 2022
TRUEdraw Lancing Device, Mini Lancing Device
K221072 · QRL
Trividia Health
General & Plastic Surgery · 189d
Cleared Oct 18, 2022
MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System
K221321 · DPS
Ge Medical Systems Information...
Cardiovascular · 165d
Cleared Oct 18, 2022
Spine CAMP™
K221632 · QIH
Medical Metrics, Inc.
Radiology · 134d
Cleared Oct 18, 2022
XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score...
K221986 · PNO
Transit Scientific, LLC
Cardiovascular · 104d
Cleared Oct 18, 2022
E-Z Chek Chlorine Residual Test Strips (K100-0101B)
K222167 · MSY
Reprocessing Products Corporation (Rpc)
Gastroenterology & Urology · 89d
Cleared Oct 18, 2022
DualXSLIM(R) T/PLIF
K222203 · MAX
Amplify Surgical, Inc.
Orthopedic · 85d
Cleared Oct 18, 2022
Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for...
K222298 · LZA
Onetexx Sdn Bhd
General Hospital · 78d
Cleared Oct 18, 2022
FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate...
K222572 · KWQ
Dio Medical Corporation
Orthopedic · 54d
Cleared Oct 18, 2022
MEBO Wound Dressing
K222657 · FRO
Mebo Life Science, Inc.
General & Plastic Surgery · 46d