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
51577–51600 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 2009
SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES
K091233 · JEY
Synthes (Usa)
Dental · 228d
Cleared Dec 11, 2009
PIEZOTOME 2
K091331 · DZI
Satelec
Dental · 220d
Cleared Dec 11, 2009
DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4
K091364 · LLZ
Oehm Und Rehbein GmbH
Radiology · 217d
Cleared Dec 11, 2009
S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023
K091711 · LCP
Alfa Wassermann Diagnostic...
Chemistry · 184d
Cleared Dec 11, 2009
INSIGHT ULTRASONIC INSERTS
K092417 · ELC
Discus Dental, LLC
Dental · 126d
Cleared Dec 11, 2009
BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203
K092505 · DBF
Beckman Coulter, Inc.
Immunology · 119d
Cleared Dec 11, 2009
LENSX 550 LASER SYSTEM
K092647 · OOE
Lensx Lasers, Inc.
Ophthalmic · 106d
Cleared Dec 11, 2009
GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS
K092682 · KCT
Gyrus Acmi, Inc.
General Hospital · 101d
Cleared Dec 11, 2009
ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE
K092943 · EJI
Arnold Tuber Industries
Dental · 78d
Cleared Dec 11, 2009
COOLTOUCH VARIA ND:YAG LASER SYSTEM
K092964 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 77d
Cleared Dec 11, 2009
DIGITAL LIGHTBOX
K093117 · LLZ
Brainlab AG
Radiology · 70d
Cleared Dec 11, 2009
NEUTRASAL
K093642 · LFD
Invado Pharmaceuticals
Dental · 17d
Cleared Dec 11, 2009
AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION
K093672 · LLZ
Sentinelle Medical, Inc.
Radiology · 14d
Cleared Dec 11, 2009
ACCUMAX
K093691 · GEX
Boston Scientific Corp
General & Plastic Surgery · 11d
Cleared Dec 10, 2009
OSTEOTAPE
K090794 · NPM
Impladent , Ltd.
Dental · 261d
Cleared Dec 10, 2009
AFGHAN EXTERNAL FIXATOR
K092002 · KTT
Smith & Nephew, Inc.
Orthopedic · 161d
Cleared Dec 10, 2009
NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4251, TD-4252, TD-4253...
K092099 · NBW
Taidoc Technology Corporation
Chemistry · 149d
Cleared Dec 10, 2009
PRESIDIO PACS
K092125 · LLZ
Reaonix Security, LLC
Radiology · 148d
Cleared Dec 10, 2009
EAGLE EYE PLATINUM DIGITAL IVUS CATHETER
K092596 · OBJ
Volcano Corporation
Radiology · 108d
Cleared Dec 10, 2009
TERUMO PRESSURE ISOLATOR
K092644 · DRS
Terumo Cardiovascular Systems Corp.
Cardiovascular · 105d
Cleared Dec 10, 2009
NEONATAL ECG ELECTRODE, M203KEN
K092744 · DRX
R & D Medical Products, Inc.
Cardiovascular · 93d
Cleared Dec 10, 2009
HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103
K092807 · DWJ
Augustine Biomedical & Design, LLC
Cardiovascular · 90d
Cleared Dec 10, 2009
SILVERSTREAM AND DERMASEPT
K093227 · FRO
Enzysurge , Ltd.
General & Plastic Surgery · 57d
Cleared Dec 10, 2009
MODIFICATION TO LANX SPINAL FIXATION SYSTEM
K093285 · MNI
Lanx, LLC
Orthopedic · 51d