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
49417–49440 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 2010
POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL,...
K100550 · LBS
Polymedco, Inc.
Chemistry · 214d
Cleared Sep 28, 2010
BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH
K101477 · LFD
Glaxosmithkline Consumer Healthcare...
Dental · 123d
Cleared Sep 28, 2010
VITEK 2 YEAST CASPOFUNGIN
K101566 · NGZ
bioMerieux, Inc.
Microbiology · 116d
Cleared Sep 28, 2010
LUXATEMP ULTRA /STAR
K101710 · EBG
Dmg USA, Inc.
Dental · 103d
Cleared Sep 28, 2010
APEX KNEE MODULAR TIBIA SYSTEM
K101994 · JWH
Omnlife Science
Orthopedic · 75d
Cleared Sep 28, 2010
DOCTOR SURGERY DIODE LASERS FAMILY
K102036 · GEX
Lambda S.P.A.
General & Plastic Surgery · 71d
Cleared Sep 28, 2010
MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMS
K102716 · GEX
Alma Lasers, Inc.
General & Plastic Surgery · 7d
Cleared Sep 27, 2010
CD HORIZON SPINAL SYSTEM
K091445 · NKB
Medtronic Sofamor Danek
Orthopedic · 500d
Cleared Sep 27, 2010
VITOMATRIX
K091618 · LYC
Orthovita, Inc.
Dental · 481d
Cleared Sep 27, 2010
SMITH & NEPHEW CIRCULAR FIXATION SYSTEM
K093047 · KTT
Smith & Nephew, Inc.
Orthopedic · 362d
Cleared Sep 27, 2010
PERCU-PRO GUIDEWIRE
K094062 · DQX
Cardiosolutions, Inc.
Cardiovascular · 270d
Cleared Sep 27, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K100421 · LYZ
Tangshan Yonkshun Glove, Co., Ltd.
General Hospital · 223d
Cleared Sep 27, 2010
ATEK SURGICAL GOWNS
K100971 · FYA
Hangzhou Atek Medical & Textile Co.,...
General Hospital · 172d
Cleared Sep 27, 2010
CONSTRUX MINI PEEK SPACER SYSTEM
K101812 · ODP
Orthofix, Inc.
Orthopedic · 90d
Cleared Sep 27, 2010
DIRECT CROWN NATURAL 1
K101814 · EBG
Candulor USA, Inc.
Dental · 90d
Cleared Sep 27, 2010
MINI MAXLOCK EXTREME PLATING SYSTEM
K101962 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 76d
Cleared Sep 27, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K102098 · LYZ
Hong DI Plastic Products Co., Ltd.
General Hospital · 62d
Cleared Sep 27, 2010
VESSEL GUARDIAN
K102136 · HIF
Lexion Medical, LLC
Obstetrics & Gynecology · 60d
Cleared Sep 24, 2010
NEURALMAS
K100992 · ETN
Innovative Surgical Solutions, LLC...
Ear, Nose, Throat · 168d
Cleared Sep 24, 2010
STALIF MIDLINE
K101301 · MAX
Centinel Spine
Orthopedic · 137d
Cleared Sep 24, 2010
QUICKVUE RSV 10
K101918 · GQG
Quidel Corp.
Microbiology · 77d
Cleared Sep 24, 2010
PATIENT MONITOR
K102040 · MHX
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 67d
Cleared Sep 24, 2010
SOCORRO SMI TUNNEL RELEASE DEVICE
K102219 · GCJ
Socorro Medical, Inc.
General & Plastic Surgery · 49d
Cleared Sep 24, 2010
FDI GLUCOSE CONTROL SOLUTIONS
K102260 · JJX
Fujirebio Diagnostics,Inc.
Chemistry · 45d