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
43177–43200 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 2012
WITHINGS, SMART BODY SCALE
K121971 · MNW
Zhongshan Transtek Electronics Co., Ltd.
Gastroenterology & Urology · 84d
Cleared Sep 27, 2012
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K122033 · JWH
Conformis, Inc.
Orthopedic · 78d
Cleared Sep 27, 2012
TYPE 1077 ACCUSCREEN
K122067 · GWJ
Gn Otometrics
Neurology · 73d
Cleared Sep 27, 2012
KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM
K122096 · HAW
KARL STORZ Endoscopy-America, Inc.
Neurology · 73d
Cleared Sep 27, 2012
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K122266 · LYZ
Shandong Junfeng Industries Co., Ltd.
General Hospital · 59d
Cleared Sep 26, 2012
STERRAD (R) 100NX DUO CYCLE TEST PACK
K111391 · FRC
Advanced Sterilization Products
General Hospital · 497d
Cleared Sep 26, 2012
ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION
K113483 · JAK
Philips Healthcare (Cleveland)
Radiology · 308d
Cleared Sep 26, 2012
EXSPIRON
K120087 · BZK
Respiratory Motion, Inc.
Anesthesiology · 259d
Cleared CT Sep 26, 2012
EMBRYOGEN
K120136 · MQL
Origio A/S
Obstetrics & Gynecology · 253d
Cleared Sep 26, 2012
ELECTRONIC STETHOSCOPE
K121144 · DQD
Sharp Corporation
Cardiovascular · 163d
Cleared Sep 26, 2012
ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
K121567 · MAX
Accel Spine
Orthopedic · 120d
Cleared Sep 26, 2012
ATHEROEDGE
K122022 · LLZ
Atheropoint, LLC
Radiology · 78d
Cleared Sep 26, 2012
PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37
K122341 · IYN
Hitachi Aloka Medical, Ltd.
Radiology · 55d
Cleared Sep 26, 2012
DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500...
K122507 · FRG
Cardinal Health200, LLC
General Hospital · 40d
Cleared Sep 26, 2012
COOLRAIL LINEAR PEN MODEL MCRI
K122611 · OCL
AtriCure, Inc.
Cardiovascular · 30d
Cleared Sep 26, 2012
SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT)...
K122623 · HRS
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 29d
Cleared Sep 25, 2012
CHF-Y0005
K113120 · FBN
Olympus Medical Systems Corp.
Gastroenterology & Urology · 340d
Cleared Sep 25, 2012
ZOLL R SERIES
K120907 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 183d
Cleared Sep 25, 2012
ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER
K121219 · DQY
Medtronic, Inc.
Cardiovascular · 155d
Cleared Sep 25, 2012
STERLING MEDICAL IMPULSE 3 STIMULATOR
K121305 · GZJ
Armstrong Industries, Inc. Dha...
Neurology · 147d
Cleared Sep 25, 2012
SURELASE CO2 LASER SYSTEM
K121580 · GEX
Clinicon Corp.
General & Plastic Surgery · 118d
Cleared Sep 25, 2012
BENCOX FORET & BENCOX DELTA
K121665 · LZO
Corentec Co., Ltd.
Orthopedic · 111d
Cleared Sep 25, 2012
CUSTOM CRANIOFACIAL IMPLANT (CCI)
K121755 · GXN
Kelyniam Global, Inc.
Neurology · 102d
Cleared Sep 25, 2012
DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID
K121880 · EBF
Danville Materials, Inc.
Dental · 89d