FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
16249–16272 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 2021
EPIEN Dental Cleanser
K201785 · KJJ
Epien Medical, Inc.
Dental · 436d
Cleared Sep 09, 2021
cobas Cdiff nucleic acid test for use on the cobas Liat System
K210385 · OZN
Roche Molecular Systems, Inc.
Microbiology · 212d
Cleared Sep 09, 2021
Curiteva Sacroiliac Joint Fusion System
K210402 · OUR
Curiteva, Inc.
Orthopedic · 211d
Cleared Sep 09, 2021
Rocket Platinum Cured Cathter
K210509 · DWM
Rocket Medical Plc
Gastroenterology & Urology · 199d
Cleared Sep 09, 2021
Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes
K211242 · FMF
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 136d
Cleared Sep 09, 2021
Electronic Thermometer (XHF2001, XHF2002)
K211352 · FLL
Putian Hanjiang Huafeng Plastic Co.,...
General Hospital · 129d
Cleared Sep 09, 2021
HERA W9, HERA W10 Diagnostic Ultrasound System
K211824 · IYN
Samsung Medison Co., Ltd.
Radiology · 87d
Cleared Sep 09, 2021
Exofin Precision Pen
K212246 · MPN
Chemence Medical, Inc.
General & Plastic Surgery · 52d
Cleared Sep 09, 2021
DIGITAL RADIOGRAPHY CXDI-Pro, D1
K212553 · MQB
Canon, Inc.
Radiology · 27d
Cleared CT Sep 08, 2021
BlueStar Rx
K203434 · NDC
Welldoc, Inc.
Chemistry · 289d
Cleared Sep 08, 2021
AmCAD-UT
K203555 · QIH
Amcad Biomed Corporation
Radiology · 275d
Cleared Sep 08, 2021
Verifine Mechanical Safety Insulin Syringe
K210712 · FMF
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 182d
Cleared Sep 08, 2021
Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM
K211127 · DXN
Health & Life Co., Ltd.
Cardiovascular · 145d
Cleared Sep 08, 2021
CIRCUL8 Luxe DVT Prevention Device
K211235 · JOW
Ortho8, Inc.
Cardiovascular · 135d
Cleared Sep 08, 2021
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic...
K211597 · IYN
Philips Medical Systems
Radiology · 107d
Cleared Sep 08, 2021
Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask
K211832 · FXX
Zhejiang Lanhine Medical Products, Ltd.
General Hospital · 86d
Cleared Sep 08, 2021
RayStation 11.0
K211867 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 84d
Cleared Sep 08, 2021
V8 Diagnostic Ultrasound System
K211945 · IYN
Samsung Medison Co., Ltd.
Radiology · 77d
Cleared Sep 08, 2021
Longeviti ClearFit™ OTS Cranial Implants
K212058 · GXN
Longeviti Neuro Solutions, LLC
Neurology · 69d
Cleared Sep 08, 2021
Leva Pelvic Health System
K212495 · HIR
Renovia, Inc.
Gastroenterology & Urology · 30d
Cleared Sep 07, 2021
Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter
K202049 · DXE
Applied Medical Resources Corporation
Cardiovascular · 410d
Cleared Sep 07, 2021
PreferX Delivery System
K210997 · FMF
Md3, LLC
General & Plastic Surgery · 158d
Cleared Sep 07, 2021
CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal...
K211579 · GEI
Bolder Surgical, LLC
General & Plastic Surgery · 109d
Cleared Sep 07, 2021
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid...
K211607 · MED
STERIS Corporation
General Hospital · 105d