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
53209–53232 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 27, 2009
ORTHODONTIC CERAMIC BRACKET
K090567 · NJM
Star Dentech Korea., Corp
Dental · 85d
Cleared May 27, 2009
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE,...
K090588 · CDD
Beckman Coulter, Inc.
Chemistry · 84d
Cleared May 27, 2009
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K090827 · LSL
Becton, Dickinson & CO
Microbiology · 62d
Cleared May 27, 2009
JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02)
K090856 · ING
Thyssenkrupp Ceteco Srl
Physical Medicine · 58d
Cleared May 27, 2009
XYLOS POROUS SURGICAL MESH
K090880 · FTM
Xylos Corporation
General & Plastic Surgery · 57d
Cleared May 27, 2009
ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089
K090943 · JJX
American Biological Technologies, Inc.
Chemistry · 54d
Cleared May 27, 2009
506CN PATIENT MONITOR
K091050 · DRT
Criticare Systems, Inc.
Cardiovascular · 44d
Cleared May 27, 2009
PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501
K091097 · FYA
Promedical Products Co., Ltd.
General Hospital · 41d
Cleared May 27, 2009
FLEXIPLAN 3D AND 3D+
K091145 · MUJ
Isodose Control B.V.
Radiology · 37d
Cleared May 27, 2009
PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511
K091195 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 34d
Cleared May 27, 2009
WU'S 3 WHEELED ELECTRICAL SCOOTER, WT-T3H
K091212 · INI
Wu'S Tech Co., Ltd.
Physical Medicine · 30d
Cleared May 27, 2009
ACTIVAPATCH
K091326 · EGJ
Activatek, Inc.
Physical Medicine · 22d
Cleared May 26, 2009
FUSION MEDICAL CANNULATED SCREW SYSTEM
K081122 · HWC
John Riccio
Orthopedic · 400d
Cleared May 26, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K090257 · DHB
Siemens Healthcare Diagnostics
Immunology · 113d
Cleared May 26, 2009
GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND
K091374 · IYO
Ge Medical Systems China Co., Ltd.
Radiology · 15d
Cleared CT May 22, 2009
DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS
K081917 · MAX
Depuy Spine, Inc.
Orthopedic · 323d
Cleared May 22, 2009
STRAUMANN MEMBRAGEL
K082111 · NPK
Institut Straumann AG
Dental · 298d
Cleared May 22, 2009
RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER
K082455 · CBF
Gulf Coast Hyperbarics, Inc.
Anesthesiology · 269d
Cleared May 22, 2009
BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034
K082589 · FED
Barosense, Inc.
Gastroenterology & Urology · 256d
Cleared May 22, 2009
ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010
K083328 · DQK
St Jude Medical
Cardiovascular · 191d
Cleared May 22, 2009
FREEDOM STIM 100 AND 200 ELECTRODE AND LEADWIRE EXTENSION
K083441 · GXY
Motion Medical Products, LLC
Neurology · 183d
Cleared May 22, 2009
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K083514 · FMF
Terumo Europe N.V.
General Hospital · 177d
Cleared May 22, 2009
ANKYLOS C/X DENTAL IMPLANT SYSTEM
K083805 · DZE
Dentsply Intl., Inc.
Dental · 151d
Cleared May 22, 2009
ENABLER-P CATHETER, 1000 PART NUMBER:1160
K083833 · DQY
Endocross, Ltd.
Cardiovascular · 150d