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
48025–48048 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared CT Mar 11, 2011
STELLAR 300
K103763 · MWI
Larsen & Toubro Limited
Cardiovascular · 78d
Cleared Mar 11, 2011
TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP
K110343 · HGX
Mayborn Baby and Child / Jackel...
Obstetrics & Gynecology · 35d
Cleared Mar 11, 2011
STEALTH 360 ORBITAL PAD SYSTEM
K110389 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 29d
Cleared Mar 11, 2011
E4D COMPASS
K110511 · LLZ
D4D Technologies
Radiology · 16d
Cleared Mar 10, 2011
DYSIS
K092433 · HEX
Forth Photonics Hellas SA
Obstetrics & Gynecology · 580d
Cleared Mar 10, 2011
DEPUY CORAIL HIP SYSTEM, REVISION STEM
K093736 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 461d
Cleared Mar 10, 2011
EASY CUFF
K102704 · BSK
Joan Spiegel, MD
Anesthesiology · 171d
Cleared Mar 10, 2011
VERIFY 270FP CHALLENGE PACK
K103053 · JOJ
STERIS Corporation
General Hospital · 146d
Cleared Mar 10, 2011
APEX POINTER+
K103123 · LQY
Micro-Mega Societe Anonyme
Dental · 140d
Cleared Mar 10, 2011
NOVEL TAPERED HIP STEM
K103479 · MEH
Stryker Corp.
Orthopedic · 104d
Cleared Mar 10, 2011
ET III SA ULTRA WIDE SYSTEM
K103537 · DZE
Hiossen, Inc.
Dental · 98d
Cleared Mar 10, 2011
CERACELL DENTAL
K103709 · LYC
Curasan AG
Dental · 80d
Cleared Mar 10, 2011
AIRSTRIP REMOTE PATIENT MONITORING (RPM)
K110503 · MWI
Airstrip Technologies, LP
Cardiovascular · 16d
Cleared Mar 09, 2011
TRINITY ACETABULAR SYSTEM
K103518 · LWJ
Corin USA
Orthopedic · 99d
Cleared Mar 09, 2011
VOLUSON S6, VOLUSON S8
K103649 · IYN
Ge Healthcare
Radiology · 84d
Cleared Mar 08, 2011
IPL THERAPY SYSTEM
K101901 · ONF
Beijing Starlight Science &...
General & Plastic Surgery · 243d
Cleared Mar 08, 2011
QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL...
K103191 · DTZ
Maquet Cardiopulmonary, AG
Cardiovascular · 131d
Cleared Mar 08, 2011
ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE
K110361 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 29d
Cleared Mar 07, 2011
SYMMETRIC TOTAL KNEE AGUMENTS
K100370 · JWH
Signal Medical Corp.
Orthopedic · 388d
Cleared Mar 07, 2011
MICRO DIARY SPIROMETER
K100928 · BZG
Viasys Respiratory Care, Inc.
Anesthesiology · 336d
Cleared Mar 07, 2011
GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES
K101250 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 307d
Cleared Mar 07, 2011
QUANTUM SPINAL SYSTEM, QUANTUM MIS
K101790 · NKB
Pioneer Surgical Technology
Orthopedic · 252d
Cleared Mar 07, 2011
ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429
K101854 · CFR
Siemens Healthcare Diagnostics
Chemistry · 249d
Cleared Mar 07, 2011
ASAHI GUIDE WIRE EXTENSION 165CM
K101985 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 236d