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
12169–12192 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 18, 2022
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
K222721 · LZA
Safeskin Retailing (Hk) Limited
General Hospital · 40d
Cleared Oct 17, 2022
CASSATT™ SIJ Fixation System
K211785 · OUR
Ctl Medical Corporation
Orthopedic · 495d
Cleared Oct 17, 2022
ATTUNE Revision Cones
K212746 · MBH
Depuy Ireland UC
Orthopedic · 413d
Cleared Oct 17, 2022
Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile
K221014 · NFB
Effortless Oxygen, LLC
Anesthesiology · 195d
Cleared Oct 17, 2022
Multi-Lancet Device 2, ReliOn Premier Lancing Device
K221175 · QRL
Arkray, Inc.
General & Plastic Surgery · 175d
Cleared Oct 17, 2022
Disposable Syringe with permanently attached needle, Safety Syringe with...
K221308 · FMF
Jiangxi Maidikang Medical Devices...
General Hospital · 165d
Cleared Oct 17, 2022
YUWELL Electronic Blood Pressure Monitor
K221372 · DXN
Jiangsu Yuyue Medical Equipment&...
Cardiovascular · 158d
Cleared Oct 17, 2022
Standalone ALIF Interbody Fusion System
K221936 · OVD
Eminent Spine
Orthopedic · 108d
Cleared Oct 17, 2022
Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet...
K222074 · LZA
Zibo Langu New Material Technology...
General Hospital · 95d
Cleared Oct 17, 2022
AcQMap High Resolution Imaging and Mapping System
K222209 · DQK
Acutus Medical, Inc.
Cardiovascular · 84d
Cleared Oct 17, 2022
Mobility Scooter, Model: W3331F
K222495 · INI
Zhejiang Innuovo Rehabilitation...
Physical Medicine · 60d
Cleared Oct 17, 2022
Zimmer Persona Personalized Knee System
K222566 · MBH
Zimmer, Inc.
Orthopedic · 54d
Cleared Oct 17, 2022
WavelinQ™ Generator
K222793 · GEI
C.R. Bard, Inc.
General & Plastic Surgery · 31d