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
60937–60960 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 07, 2006
20.1-INCH (51CM) COLOR LCD MONITOR CDL2010A (CCL204)
K063200 · LLZ
Totoku Electric Co., Ltd.
Radiology · 48d
Cleared Dec 07, 2006
THE TRUFILL DCS DETACHABLE COIL SYSTEM
K063254 · HCG
Cordis Neurovascular, Inc.
Neurology · 41d
Cleared Dec 07, 2006
LUXVISION SLIT LAMP
K063416 · HJO
Us Ophthalmic, LLC
Ophthalmic · 24d
Cleared Dec 07, 2006
ACUMED CONGRUENT BONE PLATE SYSTEM
K063460 · HRS
Acumed, LLC
Orthopedic · 22d
Cleared Dec 06, 2006
BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM
K051817 · DXC
Cardiva Medical, Inc.
Cardiovascular · 519d
Cleared Dec 06, 2006
TOTAL AND HEMI SHOULDER SYSTEM
K060988 · KWS
Dvo Extremity Solutions, LLC
Orthopedic · 240d
Cleared Dec 06, 2006
G-PROX ENDOSCOPIC GRASPER
K061276 · GAT
Usgi Medical
General & Plastic Surgery · 212d
Cleared Dec 06, 2006
PALOMAR Q-YAG 5 ND:YAG LASER SYSTEM
K061436 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 196d
Cleared Dec 06, 2006
STA - STACLOT DRVV SCREEN
K061805 · GIR
Diagnostica Stago, Inc.
Hematology · 162d
Cleared Dec 06, 2006
DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER
K061844 · JDL
Wrightmedicaltechnologyinc
Orthopedic · 160d
Cleared Dec 06, 2006
MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV,...
K062324 · MHX
Ge Healthcare
Cardiovascular · 119d
Cleared Dec 06, 2006
I-SCOPE 200
K062364 · DQD
Dongjin Medical Co., Ltd.
Cardiovascular · 114d
Cleared Dec 06, 2006
NOBELREPLACE TAPERED CONICAL CONNECTION
K062566 · DZE
Nobel Biocare USA, LLC
Dental · 97d
Cleared Dec 06, 2006
HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004
K062664 · BTT
Apex Medical Corp.
Anesthesiology · 90d
Cleared Dec 06, 2006
POWDER FREE LATEX EXAMINATION GLOVES, BLACK
K062709 · LYY
Pt. Maja Agung Latexindo
General Hospital · 86d
Cleared Dec 06, 2006
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JC1
K062867 · FLL
Microlife Intellectual Property GmbH
General Hospital · 72d
Cleared Dec 06, 2006
VERITAS COLLAGEN MATRIX
K062915 · FTM
Synovis Surgical Innovations
General & Plastic Surgery · 70d
Cleared Dec 06, 2006
NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS...
K063374 · ETB
Grace Medical, Inc.
Ear, Nose, Throat · 28d
Cleared Dec 06, 2006
DC-6 DIAGNOSTIC ULTRASOUND SYSTEM
K063500 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 16d
Cleared Dec 05, 2006
URITEST 10 URINALYSIS REAGENT STRIPS
K052719 · CDM
Arj Medical, Inc.
Chemistry · 432d
Cleared Dec 05, 2006
ARJOWRAP 47/100 AND 47/88
K062100 · FRG
Arjo Wiggins Medical, Inc.
General Hospital · 134d
Cleared Dec 05, 2006
REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS
K062435 · NFK
Spire Biomedical, Inc.
Gastroenterology & Urology · 106d
Cleared Dec 05, 2006
NEUROWAVE MICRO-INFUSION SYSTEM
K062508 · NUI
Ekos Corp.
Neurology · 99d
Cleared Dec 05, 2006
EZ-MIO, EZ-IO DISTAL TIBIA
K062956 · FMI
Vidacare Corporation
General Hospital · 67d