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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
58849–58872 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 2007
ARTHREX UNIVERS II SHOULDER PROSTHESIS
K071032 · KWS
Arthrex, Inc.
Orthopedic · 131d
Cleared Aug 20, 2007
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW...
K071316 · LRG
Dade Behring, Inc.
Microbiology · 102d
Cleared Aug 20, 2007
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW...
K071317 · LON
Dade Behring, Inc.
Microbiology · 102d
Cleared Aug 20, 2007
R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001,...
K071361 · LJS
R4 Vascular, Inc.
General Hospital · 97d
Cleared Aug 20, 2007
MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM
K071380 · NKB
Alphatec Spine, Inc.
Orthopedic · 95d
Cleared Aug 20, 2007
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, AMPICILLIN-SULBACTAM (GN)...
K071623 · LON
Becton, Dickinson & CO
Microbiology · 67d
Cleared Aug 20, 2007
URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12
K071822 · NAM
Uroplasty, Inc.
Gastroenterology & Urology · 48d
Cleared Aug 20, 2007
FORU KV10HB
K072027 · ITI
Kwang Yang Motor Co., Ltd.
Physical Medicine · 27d
Cleared Aug 20, 2007
CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04
K072096 · JPK
R&D Systems, Inc.
Hematology · 20d
Cleared Aug 17, 2007
BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER
K070002 · LJS
Boston Scientific
General Hospital · 226d
Cleared Aug 17, 2007
REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES
K070034 · NQG
Ascent Healthcare Solutions
Cardiovascular · 226d
Cleared Aug 17, 2007
REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES
K070036 · NQG
Ascent Healthcare Solutions
Cardiovascular · 226d
Cleared Aug 17, 2007
DEPUY GCK TIBIAL COMPONENTS
K070267 · HRY
DePuy Orthopaedics, Inc.
Orthopedic · 200d
Cleared Aug 17, 2007
NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F
K070970 · DQY
Penumbra, Inc.
Cardiovascular · 133d
Cleared Aug 17, 2007
ROOT ZX II
K071190 · EKX
J. Morita USA, Inc.
Dental · 109d
Cleared Aug 17, 2007
EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-100509,...
K071320 · IPF
Everlife Medical Equipment Co., Ltd.
Physical Medicine · 99d
Cleared Aug 17, 2007
SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE
K071404 · MQC
Power Products, Inc.-Splintek
Dental · 88d
Cleared Aug 17, 2007
DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS
K071518 · KDI
B. Braun Medizintechnologie GmbH
Gastroenterology & Urology · 74d
Cleared Aug 17, 2007
BIORAPTOR 2.3 PK SUTURE ANCHOR
K071586 · MBI
Smith & Nephew Inc., Endoscopy Division
Orthopedic · 67d
Cleared Aug 17, 2007
INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP
K071669 · LFL
Integra Radionics, Inc.
General & Plastic Surgery · 59d
Cleared Aug 17, 2007
GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE...
K071790 · MBH
Smith & Nephew, Inc.
Orthopedic · 46d
Cleared Aug 17, 2007
STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM
K071834 · NBC
Dade Behring, Inc.
Chemistry · 45d
Cleared Aug 17, 2007
GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND
K071985 · IYN
General Electric Co.
Radiology · 29d
Cleared Aug 17, 2007
QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V
K072060 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 21d