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
45553–45576 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 23, 2011
MED-RX EXTENSION SET WITH T-CONNECTOR
K112799 · FPA
Benlan, Inc.
General Hospital · 87d
Cleared Dec 23, 2011
EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD...
K112901 · LFR
Eps Bio Technology Corp.
Chemistry · 81d
Cleared Dec 23, 2011
STRYKER RESORBABLE FIXATION SYSTEM
K113109 · HRS
Stryker
Orthopedic · 64d
Cleared Dec 23, 2011
21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023)
K113443 · LLZ
Totoku Electric Co., Ltd.
Radiology · 32d
Cleared Dec 22, 2011
BLUE SKY BIO TCP
K110198 · LYC
Blue Sky Bio, LLC
Dental · 332d
Cleared Dec 22, 2011
CELL-DYN EMERALD 22 SYSTEM
K110381 · GKZ
Abbott Laboratories
Hematology · 315d
Cleared Dec 22, 2011
SENOGRAPHE DS, SENOGRAPHE ESSENTIAL
K110798 · MUE
General Electric Company
Radiology · 275d
Cleared Dec 22, 2011
HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME
K111159 · DPS
Cardiocomm Solutions, Inc.
Cardiovascular · 241d
Cleared Dec 22, 2011
CELL-DYN 22 PLUS CALIBRATOR
K111204 · KRX
Streck
Hematology · 237d
Cleared Dec 22, 2011
CELL-DYN 22 PLUS CONTROL
K111211 · GLQ
Streck
Hematology · 237d
Cleared Dec 22, 2011
CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER
K111324 · MUE
Agfa Healthcare N.V.
Radiology · 225d
Cleared Dec 22, 2011
PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1
K111617 · DQA
Acare Technology Co., Ltd.
Anesthesiology · 195d
Cleared Dec 22, 2011
IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS
K111919 · DHB
Phadia US, Inc.
Immunology · 168d
Cleared Dec 22, 2011
KOO SMALL VOLUME NEBULIZER (SVN)
K112041 · CAF
Koo (Shanghai) Industries Co., Ltd.
Anesthesiology · 157d
Cleared Dec 22, 2011
THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA...
K112109 · LLZ
Ortho Kinematics, Inc.
Radiology · 153d
Cleared Dec 22, 2011
QUIDEL MOLECULAR INFLUENZA A + B ASSAY
K112172 · OCC
Quidel Corp.
Microbiology · 147d
Cleared Dec 22, 2011
U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM
K112216 · DXN
Taidoc Technology Corporation
Cardiovascular · 142d
Cleared Dec 22, 2011
COLLAGEN TENDON SHEET
K112423 · FTM
Rotation Medical, Inc.
General & Plastic Surgery · 121d
Cleared Dec 22, 2011
PENCAN SPINAL NEEDLE
K112515 · BSP
B.Braun Medical, Inc.
Anesthesiology · 114d
Cleared Dec 22, 2011
TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER
K112776 · MUJ
Tomotherapy Incorporated
Radiology · 87d
Cleared Dec 22, 2011
MANUJET III
K112783 · BTL
VBM Medizintechnik GmbH
Anesthesiology · 87d
Cleared Dec 22, 2011
CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G
K112907 · NDN
Medos International SARL
Orthopedic · 80d
Cleared Dec 22, 2011
VARI-LASE WIREFIBER LASER FIBER
K113140 · GEX
Vascular Solutions, Inc.
General & Plastic Surgery · 58d
Cleared Dec 22, 2011
SYNAPSE MPR FUSION
K113244 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 50d