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
77785–77808 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 2001
MODIFICATION TO THE GRIP
K010526 · LIX
Elcare Innovations, Inc.
Cardiovascular · 294d
Cleared Dec 13, 2001
SPINE SCOPE, MODEL 2180
K011454 · HRX
Clarus Medical, LLC
Orthopedic · 216d
Cleared Dec 13, 2001
3D HUMERAL HEADS
K012378 · KWS
Smith & Nephew, Inc.
Orthopedic · 140d
Cleared Dec 13, 2001
CAIRD TECHNOLOGY HOLTER 2000
K012686 · DPS
Caird Technology
Cardiovascular · 121d
Cleared Dec 13, 2001
WET LIGHT PERSONAL MOISTURIZER
K013086 · HIS
Trigg Laboratories, Inc.
Obstetrics & Gynecology · 90d
Cleared Dec 13, 2001
SOPRO 67D OPERATING ROOM CAMERA
K013090 · GCJ
Sopro
General & Plastic Surgery · 87d
Cleared Dec 13, 2001
HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K013092 · DQX
Guidant Corp.
Cardiovascular · 87d
Cleared Dec 13, 2001
AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM
K013242 · FTD
STERIS Corporation
General & Plastic Surgery · 76d
Cleared Dec 13, 2001
DXS DIGITAL X-RAY SYSTEM
K013271 · MUH
Douglas C. Yoon, Dds
Radiology · 73d
Cleared Dec 13, 2001
ENDOFLIP
K013334 · MBI
Arthocare Corporation
Orthopedic · 65d
Cleared Dec 13, 2001
PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI
K013337 · HNO
Surgin, Inc.
Ophthalmic · 65d
Cleared Dec 13, 2001
DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEM
K013358 · DXN
Pulse Metric, Inc.
Cardiovascular · 64d
Cleared Dec 13, 2001
CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH
K013367 · DPS
Reynolds Medical , Ltd.
Cardiovascular · 64d
Cleared Dec 13, 2001
INDIGO OPTIMA LASER SYSTEM
K013493 · GEX
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 52d
Cleared Dec 13, 2001
INVACARE ELEVATING SEAT OPTION ESS6
K013516 · ITI
Invacare Corp.
Physical Medicine · 51d
Cleared Dec 13, 2001
CRYSTAL 5000 PHASES ARRAY TMJ COIL
K013528 · MOS
Usa Instruments, Inc.
Radiology · 51d
Cleared Dec 13, 2001
MODIFICATION TO EBI XFIX DFS SYSTEM
K013739 · LXT
Ebi, L.P.
Orthopedic · 30d
Cleared Dec 13, 2001
ULTRASAFE DENTAL INJECTION SYSTEM
K013801 · MEG
Safety Syringes, Inc.
General Hospital · 28d
Cleared Dec 13, 2001
MEDRAD QWIK-FIT SYRINGE
K013815 · DXT
Medrad, Inc.
Cardiovascular · 27d
Cleared Dec 13, 2001
IMMUNO-TROL LOW CELLS
K013842 · JPK
Beckman Coulter, Inc.
Hematology · 23d
Cleared Dec 13, 2001
ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS
K013935 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 15d
Cleared Dec 13, 2001
NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84)...
K013992 · CEW
Nichols Institute Diagnostics
Chemistry · 9d
Cleared Dec 12, 2001
BIOSPEED
K013069 · FCG
H.S. Hospital Services S.P.A.
Gastroenterology & Urology · 90d
Cleared Dec 12, 2001
JAMSHIDI BIOPSY NEEDLE
K013070 · FCG
H.S. Hospital Services S.P.A.
Gastroenterology & Urology · 90d