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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
76849–76872 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 18, 2002
EVTOOL MODEL # V. 1.0
K013535 · MUJ
3D Line USA, Inc.
Radiology · 87d
Cleared Jan 18, 2002
PLLA CANNULATED INTERFERENCE SCREW
K013685 · HWC
Future Medical Systems, Inc.
Orthopedic · 72d
Cleared Jan 18, 2002
ADVIA 1650 CHOLINESTERASE ASSAY
K013750 · DIH
Bayer Diagnostics Corp.
Chemistry · 66d
Cleared Jan 18, 2002
MODIFICATION TO: WINNER ST-2 STIMULATOR
K013770 · IPF
Rich-Mar Corp.
Physical Medicine · 66d
Cleared Jan 18, 2002
MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND...
K013771 · IPF
Rich-Mar Corp.
Physical Medicine · 66d
Cleared Jan 18, 2002
AUTION MAX AX-4280 URINALYSIS SYSTEM
K013783 · KQO
International Remote Imaging Systems
Chemistry · 65d
Cleared Jan 18, 2002
TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T
K013894 · MOS
Philips Medical Systems North...
Radiology · 56d
Cleared Jan 18, 2002
CREATINE KINASE (CK-NAC)
K013912 · CGS
Jas Diagnostics, Inc.
Chemistry · 52d