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.

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

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175,820 results
38353–38376 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 2014
ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR...
K134045 · NHA
Zimmer Dental, Inc.
Dental · 115d
Cleared Apr 25, 2014
EASY GO VAC
K140179 · BTA
Precision Medical, Inc.
General & Plastic Surgery · 91d
Cleared Apr 25, 2014
MTA FILLAPEX
K140247 · KIF
Angelus Industria DE Productos...
Dental · 85d
Cleared Apr 25, 2014
PINIT SMALL BONE FUSION SYSTEM
K140617 · HRS
Arthrosurface, Inc.
Orthopedic · 45d
Cleared Apr 25, 2014
MYLABSSOGNO
K140677 · IYN
Esaote, S.P.A.
Radiology · 38d
Cleared Apr 25, 2014
RELIANCE ANTERIOR CERVICAL PLATE
K140742 · KWQ
Reliance Medical Systems, LLC
Orthopedic · 31d
Cleared Apr 25, 2014
INFINITY TOTAL ANKLE SYSTEM
K140749 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 31d
Cleared Apr 25, 2014
LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK
K140764 · JJY
Bio-Rad Laboratories
Immunology · 29d
Cleared Apr 25, 2014
PHILIPS ELEVA WORKSPOT
K140771 · MQB
Philips Medical Systems Dmc GmbH
Radiology · 29d
Cleared Apr 25, 2014
TERASON USMART3400 ULTRASOUND SYSTEM
K140834 · IYN
Teratech Corp.
Radiology · 23d
Cleared Apr 25, 2014
INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR...
K140851 · OEP
Centers For Disease Control and...
Microbiology · 22d
Cleared Apr 25, 2014
INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME...
K140857 · OZE
Centers For Disease Control and...
Microbiology · 22d
Cleared Apr 24, 2014
NEURAGEN 3D
K130557 · JXI
Integra LifeSciences Corporation
Neurology · 416d
Cleared Apr 24, 2014
SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
K131525 · MKJ
Defibtech, LLC
Cardiovascular · 331d
Cleared Apr 24, 2014
DIODE LASER FOR HIAR REMOVAL
K131838 · GEX
Beijing Honkon Technologies Co., Ltd.
General & Plastic Surgery · 308d
Cleared Apr 24, 2014
QUICK RELAX PRO
K131956 · NUH
Healthcare Innovations, LLC
Neurology · 301d
Cleared Apr 24, 2014
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K132433 · EOB
Acclarent, Inc.
Ear, Nose, Throat · 262d
Cleared Apr 24, 2014
PINOOK STIMULATOR
K132563 · NUH
Pinook USA
Neurology · 252d
Cleared Apr 24, 2014
ELECTRIC BREAST PUMP
K132882 · HGX
Shantou Xinghe Electrical Apparatuses...
Obstetrics & Gynecology · 223d
Cleared Apr 24, 2014
COUNTER OTC TENS DEVICE
K132993 · NUH
Counter Scientific Development (Gz),...
Neurology · 212d
Cleared Apr 24, 2014
DX3000-L
K133007 · MUH
Dexcowin Co., Ltd.
Radiology · 211d
Cleared Apr 24, 2014
DISCOVERY IGS 740
K133278 · OWB
GE Medical Systems SCS
Radiology · 182d
Cleared Apr 24, 2014
FLUID LEVEL MONITOR
K133870 · FLN
Coleman Laboratories
General Hospital · 125d
Cleared Apr 24, 2014
LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL,...
K134013 · JJY
Bio-Rad Laboratories
Immunology · 115d