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
62281–62304 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 2006
INSPECTRA STO2 TISSUE OXYGENATION MONITOR
K061619 · MUD
Hutchinson Technology, Inc.
Cardiovascular · 33d
Cleared Jul 12, 2006
GE VOLUSON E8 ULTRASOUND SYSTEM
K061682 · IYO
General Electric Co.
Radiology · 27d
Cleared Jul 12, 2006
MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR
K061698 · JDK
Life Spine
Orthopedic · 26d
Cleared Jul 12, 2006
TAP-T
K061732 · LRK
Airway Management, Inc.
Dental · 22d
Cleared Jul 12, 2006
GALAXY
K061816 · MWI
Larsen & Toubro Limited
Cardiovascular · 14d
Cleared Jul 12, 2006
LIGHTSPEED 7.1 CT SCANNER SYSTEM
K061817 · JAK
Ge Medical Systems, LLC
Radiology · 14d
Cleared Jul 12, 2006
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS
K061859 · MSH
Inovel, LLC
General Hospital · 12d
Cleared Jul 11, 2006
BABYAIR
K060497 · CAF
Promedic, Inc.
Anesthesiology · 137d
Cleared Jul 11, 2006
HEAD BED
K060986 · FRP
Steven H. Warnock, M.D.
General Hospital · 92d
Cleared Jul 11, 2006
COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE
K061011 · HSX
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Jul 11, 2006
SIMEX SUCTION PUMP, MODELS AC20, AC20K, AC30, DC20, DC30 AND DC30S
K061133 · BTA
Novaspine, LLC
General & Plastic Surgery · 78d
Cleared Jul 11, 2006
MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010
K061135 · GWG
Aesculap
Neurology · 78d
Cleared Jul 11, 2006
SNUG PLUG PUNCTUM PLUG
K061398 · LZU
Fci Ophthalmics, Inc.
Ophthalmic · 53d
Cleared Jul 11, 2006
VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR
K061562 · LYZ
Grand Work Plastic Products Co., Ltd.
General Hospital · 36d
Cleared Jul 11, 2006
TRIACTIV FX EMBOLIC PROTECTION SYSTEM
K061772 · NFA
Kensey Nash Corp.
Cardiovascular · 18d
Cleared Jul 11, 2006
BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
K061788 · OMP
Boehringer Laboratories
General & Plastic Surgery · 15d
Cleared Jul 11, 2006
FOCUS VNG/ENG TYPE 1068
K061791 · GWN
Gn Otometrics A/S
Neurology · 15d
Cleared Jul 10, 2006
COMPUFLO
K053554 · FRN
Milestone Scientific, Inc.
General Hospital · 202d
Cleared Jul 10, 2006
TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414
K060788 · DIF
Biosite Incorporated
Chemistry · 109d
Cleared Jul 10, 2006
CAREO SAFETY SYRINGE FOR U-100 INSULIN
K061055 · MEG
Life-Shield Products, Inc.
General Hospital · 84d
Cleared Jul 10, 2006
BIOTRONIK ENDOCARDIAL PACING LEADS
K061212 · DTB
Biotronik, Inc.
Cardiovascular · 70d
Cleared Jul 10, 2006
SIMULATE, COLOR CHANGE ALGINATE
K061267 · ELW
Cavex Holland BV
Dental · 66d
Cleared Jul 10, 2006
DENLASER 800 PLUS
K061366 · GEX
CAO Group, Inc.
General & Plastic Surgery · 55d
Cleared Jul 10, 2006
R&D CBC-3D + CRP HEMATOLOGY CONTROL
K061511 · JPK
R&D Systems, Inc.
Hematology · 39d