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

Filters: Cleared only ×
175,820 results
20353–20376 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 2020
TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable...
K192636 · FTL
Medtronic, Inc.
General & Plastic Surgery · 198d
Cleared Apr 08, 2020
AIMI-Triage CXR PTX
K193300 · QFM
Radlogics, Inc.
Radiology · 133d
Cleared Apr 08, 2020
Go2Wire Guide Wire
K193571 · DQX
Merit Medical System, Inc.
Cardiovascular · 107d
Cleared Apr 08, 2020
HI-TORQUE Steelcore Bare Guide Wire
K200144 · DQX
Abbott Vascular
Cardiovascular · 77d
Cleared Apr 08, 2020
Orfit Aerial Couchtop
K200282 · LHN
Orfit Industries NV
Radiology · 64d
Cleared Apr 08, 2020
Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System
K200411 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 49d
Cleared Apr 08, 2020
Flex Body Speeder
K200477 · MOS
Quality Electrodynamics, LLC
Radiology · 41d
Cleared Apr 08, 2020
Voyant Maryland Fusion Device
K200598 · GEI
Applied Medical Resources Corp.
General & Plastic Surgery · 30d
Cleared Apr 08, 2020
TCAT TKA Instrument Tray Set
K200632 · KCT
THINK Surgical, Inc.
General Hospital · 29d
Cleared Apr 07, 2020
The Optimotion Blue Total Knee System
K191084 · MBH
Optimotion Implants, LLC
Orthopedic · 349d
Cleared Apr 07, 2020
VERTICALE® Cervical System
K192013 · NKG
Silony Medical GmbH
Orthopedic · 253d
Cleared Apr 07, 2020
Innovision Audio
K193218 · LNH
Innovere Medical, Inc.
Radiology · 138d
Cleared Apr 07, 2020
BlueStar Rx
K193654 · MRZ
Welldoc, Inc.
Chemistry · 99d
Cleared Apr 07, 2020
BD Centro Vena Acute Central Line (7 French Dual Lumen)
K200266 · FOZ
Bard Access Systems, Inc. (Bard Has...
General Hospital · 64d
Cleared Apr 07, 2020
HS40 Diagnostic Ultrasound System
K200339 · IYN
Samsung Medison Co., Ltd.
Radiology · 56d
Cleared Apr 06, 2020
Neural Navigator
K191422 · HAW
Soterix Medical, Inc.
Neurology · 313d
Cleared Apr 06, 2020
Diode Laser Hair Removal System
K191970 · GEX
Beijing Sano Laser S&T Development...
General & Plastic Surgery · 257d
Cleared Apr 06, 2020
Straumann Screw-Retained Abutments
K192401 · NHA
Straumann USA, LLC
Dental · 216d
Cleared Apr 06, 2020
Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer
K192500 · DXQ
Honsun (Nantong) Co., Ltd.
Cardiovascular · 207d
Cleared Apr 06, 2020
Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access...
K192558 · DQY
Mivi Neurovascular
Neurology · 202d
Cleared Apr 06, 2020
SensiCare PI and SensiCare PI Micro Surgical Gloves
K193217 · KGO
Medline Industries, Inc.
General Hospital · 137d
Cleared Apr 06, 2020
Irrigation Tubing with CO2 or Air
K193250 · OCX
Keymed (Medical and Industrial...
Gastroenterology & Urology · 133d
Cleared Apr 06, 2020
Origin™ Anterior Cervical Plate System
K193494 · KWQ
Orthopaedic & Spine Development
Orthopedic · 111d
Cleared Apr 06, 2020
Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs...
K200019 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 94d