Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
77449–77472 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 2002
POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR...
K013795 · LYY
Shen Wei (Usa), Inc.
General Hospital · 69d
Cleared Jan 22, 2002
AIMSTEP PREGNANCY
K013857 · DHA
Germaine Laboratories, Inc.
Chemistry · 62d
Cleared Jan 22, 2002
INFINION 0.6T MR IMAGING SYSTEM
K013858 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 62d
Cleared Jan 22, 2002
R&D RET-LINE KIT
K013898 · JPK
R&D Systems, Inc.
Hematology · 60d
Cleared Jan 22, 2002
POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)
K014134 · FMC
Supergrade Healthcare Products Sdn. Bhd.
General Hospital · 36d
Cleared Jan 22, 2002
STIMULUS - DISSECTION INSTRUMENTS
K014165 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 34d
Cleared Jan 22, 2002
6F MACH1/34356-XXX
K020028 · DQY
Boston Scientific
Cardiovascular · 18d
Cleared Jan 18, 2002
BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS)
K010549 · FGE
Medi-Globe Corp.
Gastroenterology & Urology · 326d
Cleared Jan 18, 2002
BIOTECH POWERED WHEELCHAIR, C650PW
K011846 · ITI
Roc Chinese-European Industrial...
Physical Medicine · 220d
Cleared Jan 18, 2002
VASCULAR SOLUTIONS DUETT FLOWABLE HEMOSTAT
K012293 · QSX
Vascular Solutions, Inc.
General & Plastic Surgery · 182d
Cleared Jan 18, 2002
HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER
K012328 · KPO
Di-Chem, Inc.
Gastroenterology & Urology · 179d
Cleared Jan 18, 2002
WATERLASE MILLENNIUM
K012511 · MXF
Biolase Technology, Inc.
Dental · 165d
Cleared Jan 18, 2002
HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION
K012547 · KPO
Di-Chem, Inc.
Gastroenterology & Urology · 164d
Cleared Jan 18, 2002
REPROCESSED ELECTROSURGICAL ELECTRODE
K012684 · JOS
Sterilmed, Inc.
General & Plastic Surgery · 157d
Cleared Jan 18, 2002
THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG...
K012943 · NAL
Quantech , Ltd.
Chemistry · 140d
Cleared Jan 18, 2002
DURQ/ QUALIDURA
K013116 · BTA
Ever-Safety Technical Service
General & Plastic Surgery · 122d
Cleared Jan 18, 2002
N LATEX LP(A)
K013128 · DFC
Dade Behring, Inc.
Chemistry · 121d
Cleared Jan 18, 2002
DADE THROMBOPLASTIN C PLUS
K013155 · GJS
Dade Behring, Inc.
Hematology · 119d
Cleared Jan 18, 2002
USA SERIES LAPAROSCOPES
K013165 · GCJ
Circon Acmi
General & Plastic Surgery · 119d
Cleared Jan 18, 2002
3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR
K013228 · JOJ
Minnesota Mining and Mfg. Co.
General Hospital · 113d
Cleared Jan 18, 2002
3.75MM AND 5.0MM SPLINE TWIST IMPLANT
K013494 · DZE
Sulzer Dental, Inc.
Dental · 88d
Cleared Jan 18, 2002
POINT 4 MODIFIED
K013510 · EBF
Sybron Dental Specialties, Inc.
Dental · 88d
Cleared Jan 18, 2002
EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM
K013518 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 87d
Cleared Jan 18, 2002
EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)
K013533 · DRG
General Devices
Cardiovascular · 87d