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
67393–67416 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 24, 2004
15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER
K040328 · MSD
Medcomp
Gastroenterology & Urology · 288d
Cleared Nov 24, 2004
THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS
K041427 · CGA
Arkray, Inc.
Chemistry · 180d
Cleared Nov 24, 2004
IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE)
K041747 · DJG
Lifepoint,Inc
Chemistry · 148d
Cleared Nov 24, 2004
FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5
K042043 · FDS
Fujinon, Inc.
Gastroenterology & Urology · 118d
Cleared Nov 24, 2004
NX STAGE WATER PURIFICATION SYSTEM
K042089 · FIP
Nxstage Medical, Inc.
Gastroenterology & Urology · 113d
Cleared Nov 24, 2004
DRY LASER IMAGER, MODEL DRYPRO MODEL 793
K042133 · LMC
Konica Minolta Medical & Graphic, Inc.
Radiology · 107d
Cleared Nov 24, 2004
GUIDEWIRES
K042264 · DQX
Rocket Medical Plc
Cardiovascular · 93d
Cleared Nov 24, 2004
KASIOS TCP
K042340 · MQV
Kasios Biomaterials
Orthopedic · 86d
Cleared Nov 24, 2004
AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLAYS
K042353 · LLZ
National Display Systems
Radiology · 86d
Cleared Nov 24, 2004
MUCOTROL CONCENTRATED ORAL GEL WAFER
K042400 · OLR
Belcher Pharmaceuticals, Inc.
General & Plastic Surgery · 82d
Cleared Nov 24, 2004
SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL
K042443 · CHH
Arkray, Inc.
Chemistry · 76d
Cleared Nov 24, 2004
X-2 IMPLANT ABUTMENT
K042466 · NHA
Zest Anchors, Inc.
Dental · 72d
Cleared Nov 24, 2004
ADSEAL ROOT CANAL SEALER
K042769 · KIF
Meta Biomed Co., Ltd.
Dental · 50d
Cleared Nov 24, 2004
QUADRANT UNIT-1-BOND
K042806 · KLE
Cavex Holland BV
Dental · 43d
Cleared Nov 24, 2004
KOBRA GPS FIXATION SYSTEM
K042859 · KWQ
Medtronic Vertelink, Inc.
Orthopedic · 40d
Cleared Nov 24, 2004
LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S)
K042865 · DIF
Bio-Rad
Chemistry · 37d
Cleared Nov 24, 2004
GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO
K042960 · NSI
Given Imaging , Ltd.
Gastroenterology & Urology · 28d
Cleared Nov 24, 2004
MCL 30 DERMABLATE ER:YAG LASER SYSTEM
K042968 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 27d
Cleared Nov 24, 2004
X-LEONARDO
K042995 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 23d
Cleared Nov 24, 2004
COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE
K042996 · DQX
Volcano Therapeutics, Inc.
Cardiovascular · 23d
Cleared Nov 24, 2004
TRIGEN HINDFOOT FUSION NAIL
K043052 · HSB
Smith & Nephew, Inc.
Orthopedic · 19d
Cleared Nov 24, 2004
COMMANDER II
K043096 · DXN
Cardiocom
Cardiovascular · 15d
Cleared Nov 24, 2004
GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM
K043112 · LNH
General Electric Co.
Radiology · 14d
Cleared Nov 24, 2004
ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE
K043175 · NHG
Roche Diagnostics Corp.
Chemistry · 8d