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
42433–42456 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 2012
WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST...
K122961 · DKZ
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 87d
Cleared Dec 21, 2012
INTEGRA TOTAL FOOT SYSTEMS
K123000 · HRS
Integra LifeSciences Corporation
Orthopedic · 85d
Cleared Dec 21, 2012
CERAMIN BRACKETS Z
K123092 · NJM
Tomy, Inc.
Dental · 80d
Cleared Dec 21, 2012
KOGENT BIPOLAR FORCEPS
K123172 · GEI
Katalyst Surgical, LLC
General & Plastic Surgery · 73d
Cleared Dec 21, 2012
XPERT FLU
K123191 · OCC
Cepheid
Microbiology · 71d
Cleared Dec 21, 2012
DETACHATIP III
K123260 · GEI
Conmed Corporation
General & Plastic Surgery · 64d
Cleared Dec 21, 2012
ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON,...
K123341 · MBI
Arthrex, Inc.
Orthopedic · 51d
Cleared Dec 21, 2012
E-CUBE 7
K123611 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 30d
Cleared Dec 21, 2012
PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM
K123616 · IYO
Sonoscape Company Limited
Radiology · 28d
Cleared Dec 21, 2012
HAMILTON-C3
K123637 · CBK
Hamilton Medical AG
Anesthesiology · 25d
Cleared Dec 21, 2012
TRANSTEK WRIST BLOOD PRESSURE MONITOR
K123669 · DXN
Zhongshan Transtek Electronics Co., Ltd.
Cardiovascular · 22d
Cleared Dec 21, 2012
VERSARATE FLOW RATE CONTROLER
K123729 · FPA
Emed Technologies Corporation
General Hospital · 16d
Cleared Dec 21, 2012
CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM
K123754 · IYN
Philips Ultrasound, Inc.
Radiology · 15d
Cleared Dec 21, 2012
KYPHON EXPRESS II INFLATABLE BONE TAMPS
K123771 · HRX
Medtronic
Orthopedic · 14d
Cleared Dec 21, 2012
X-TRA BASE
K123773 · EBF
Voco GmbH
Dental · 14d
Cleared Dec 21, 2012
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
K123836 · GAM
Surgical Specialties Corp. Dba Angiotech
General & Plastic Surgery · 8d
Cleared Dec 20, 2012
CURASAN OSSEOLIVE DENTAL
K111105 · LYC
Curasan AG
Dental · 610d
Cleared Dec 20, 2012
SYNTEC DENTAL IMPLANT
K111189 · DZE
Syntec Scientific Corp.
Dental · 602d
Cleared Dec 20, 2012
AP 72OS SEMI-AUTOMATED INSTRUMENT
K112910 · DHB
Hitachi Chemical Diagnostics, Inc.
Immunology · 444d
Cleared Dec 20, 2012
ENDOSCOPE REPROCESSOR OER-MINI
K120357 · FEB
Olympus Medical Systems Corp.
General Hospital · 318d
Cleared Dec 20, 2012
DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH
K121027 · JIT
Diamond Diagnostics, Inc.
Chemistry · 260d
Cleared Dec 20, 2012
STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT
K121046 · PCG
Kronus Market Development Associates,...
Immunology · 258d
Cleared Dec 20, 2012
WANDY DISPERSVIE ELECTRODE
K121268 · ODR
Bio-Med USA, Inc.
General & Plastic Surgery · 238d
Cleared Dec 20, 2012
PANOPTIC
K121405 · HKI
Welch Allyn, Inc.
Ophthalmic · 224d