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

Filters: Cleared only ×
175,820 results
48193–48216 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 17, 2011
ROCKWOOD CLAVICLE PINS
K103001 · JDW
DePuy Orthopaedics, Inc.
Orthopedic · 134d
Cleared Feb 17, 2011
FILMARRAY RESPIRATORY PANEL (RP)
K103175 · OCC
Idaho Technology, Inc.
Microbiology · 112d
Cleared Feb 17, 2011
SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM
K103383 · NKB
Spartek Medical, Inc.
Orthopedic · 91d
Cleared Feb 17, 2011
IVOBASE HYBRID, IVOBASE HIGH IMPACT
K103391 · EBI
Ivoclar Vivadent, Inc.
Dental · 90d
Cleared Feb 17, 2011
EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM
K103490 · NKB
Johnson & Johnson
Orthopedic · 83d
Cleared Feb 17, 2011
GOLIFE NASAL MASK
K110008 · BZD
Respironics, Inc.
Anesthesiology · 45d
Cleared Feb 17, 2011
STIMTRODE SINGLE USE NERVE STIMULATOR
K110118 · BXN
Xavant Technology (Pty), Ltd.
Anesthesiology · 30d
Cleared Feb 17, 2011
ZOLL AED PLUS WITH 2010 AHA GUIDLINES SOFTWARE UPDATE
K110154 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 29d
Cleared Feb 17, 2011
BEL-CYPHER N
K110160 · MUH
Takara Belmont Corporation
Radiology · 29d
Cleared Feb 17, 2011
ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE
K110168 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 28d
Cleared Feb 17, 2011
ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
K110207 · IYN
Aloka Co., Ltd.
Radiology · 23d
Cleared Feb 17, 2011
G-SCAN
K110238 · LNH
Esaote, S.P.A.
Radiology · 22d
Cleared Feb 16, 2011
DYNAREX ULTRASOUND GEL
K102637 · MUI
Dynarex Corporation
Radiology · 155d
Cleared Feb 16, 2011
DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES
K103321 · FRC
Dana Products, Inc.
General Hospital · 96d
Cleared Feb 16, 2011
GDC 360 DETEACHABLE COIL
K103355 · HCG
Boston Scientific Corp
Neurology · 92d
Cleared Feb 16, 2011
ZENOSTAR MAGIC GLAZE
K103494 · EIH
Wieland Dental + Technik GmbH & Co. KG
Dental · 79d
Cleared Feb 16, 2011
CONMED R SABRE GENESIS TM ELECTROSURGICAL UNIT
K103665 · GEI
Conmed Corporation
General & Plastic Surgery · 62d
Cleared Feb 16, 2011
CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM
K103678 · DQK
Ge Medical Systems Information...
Cardiovascular · 62d
Cleared Feb 16, 2011
ENZYME II CALIBRATOR
K103836 · JIT
Siemens Healthcare Diagnostics, Inc.
Chemistry · 48d
Cleared Feb 16, 2011
ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE
K110183 · NDN
Arthrocare Corp.
Orthopedic · 26d
Cleared Feb 15, 2011
SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE
K091207 · HTN
Surgicraft , Ltd.
Orthopedic · 662d
Cleared Feb 15, 2011
ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS...
K102109 · DTZ
Eurosets S.R.L
Cardiovascular · 202d
Cleared Feb 15, 2011
FINESS ENDOSCOPE
K102366 · EOB
Entellus Medical, Inc.
Ear, Nose, Throat · 179d
Cleared Feb 15, 2011
ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR
K102762 · MTJ
Orthocon, Inc.
General & Plastic Surgery · 144d