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
62833–62856 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 12, 2006
MEDTOX OXYCODONE
K060351 · DJG
Medtox Diagnostics, Inc.
Toxicology · 88d
Cleared May 12, 2006
IVENA VASCULAR PATCH
K060396 · DXZ
Atrium Medical Corp.
Cardiovascular · 86d
Cleared May 12, 2006
MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM
K060479 · FRN
Caesarea Medical Electronics , Ltd.
General Hospital · 78d
Cleared May 12, 2006
POLYAX LOCKED PLATING SYSTEM
K060969 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 35d
Cleared May 12, 2006
FLIGHT
K061186 · IOR
Aero Innovative Research, Inc.
Physical Medicine · 14d
Cleared May 12, 2006
TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING
K061187 · JAK
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared May 11, 2006
BACSTOP
K053405 · FMG
Elcam Medical Acal
General Hospital · 155d
Cleared May 11, 2006
KONICA MINOLTA PULSOX-300, 300I
K053419 · DQA
Konica Minolta Sensing, Inc.
Anesthesiology · 154d
Cleared May 11, 2006
MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW,...
K060198 · HRX
Linvatec Corp.
Orthopedic · 105d
Cleared May 11, 2006
LIFE SPINE CEMENT RESTRICTOR
K060247 · JDK
Life Spine
Orthopedic · 100d
Cleared May 11, 2006
BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000
K060343 · DJZ
Sentech Korea Corp.
Toxicology · 90d
Cleared May 11, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEPHALOTHIN - GN 1 - 64 UG/ML
K060558 · LON
Becton, Dickinson & CO
Microbiology · 70d
Cleared May 11, 2006
ENZYME IMMUNOASSAY, VANCOMYCIN
K060586 · LEH
Roche Diagnostics Corp.
Toxicology · 65d
Cleared May 11, 2006
RS-1000 ZOOM SLITLAMP WITH OPTION
K060869 · HJO
Rightmedical Products, LLC
Ophthalmic · 42d
Cleared May 11, 2006
IG4 IMAGE GUIDED SYSTEM
K060903 · JAK
Veran Medical Technologies, Inc.
Radiology · 38d
Cleared May 10, 2006
HIPSTAR FEMORAL STEM
K051223 · LZO
Stryker Orthopaedics
Orthopedic · 363d
Cleared May 10, 2006
ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM...
K052308 · JZO
Fisher Diagnostics
Immunology · 259d
Cleared May 10, 2006
SURETEK MEDICAL REPROCESSED ELECTROSURGICAL ELECTRODES
K052692 · NUJ
Suretek Medical
General & Plastic Surgery · 224d
Cleared May 10, 2006
SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS
K052695 · NUJ
Suretek Medical
General & Plastic Surgery · 224d
Cleared May 10, 2006
LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT
K053244 · GWM
Integra Lifesciences Corp.
Neurology · 170d
Cleared May 10, 2006
ESTECH AORTIC EASY FLOW CANNULA
K060101 · DWF
Endoscopic Technologies, Inc.
Cardiovascular · 118d
Cleared May 10, 2006
CRYOCHECK CLOT APCR
K060284 · GGW
Precision Biologic, Inc.
Hematology · 96d
Cleared May 10, 2006
SIGMA ALPHA VAPORIZER
K060331 · CAD
Penlon Limited
Anesthesiology · 90d
Cleared May 10, 2006
ORAMAGIC PLUS ORAL WOUND RINSE
K060340 · OLR
Mpm Medical., Inc.
General & Plastic Surgery · 89d