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
61321–61344 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 2006
SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69,...
K061416 · DQY
Medtronic Vascular
Cardiovascular · 156d
Cleared Oct 25, 2006
DARCO FORCE TITANIUM COMPRESSION SCREW
K062103 · HWC
Darco International, Inc.
Orthopedic · 93d
Cleared Oct 25, 2006
UNICEM
K062292 · EMA
3M Espe Dental Products
Dental · 79d
Cleared Oct 25, 2006
TELEVISIT
K062338 · DQA
PHD Medical
Anesthesiology · 76d
Cleared Oct 25, 2006
C. ALBICANS PNA FISH
K062461 · JXB
Advandx, Inc.
Microbiology · 63d
Cleared Oct 25, 2006
PROFYLE SYSTEM
K062498 · HRS
Howmedica Osteonics Corp.
Orthopedic · 61d
Cleared Oct 25, 2006
TOMAS PIN 6 MM
K062732 · OAT
Dentaurum
Dental · 42d
Cleared Oct 24, 2006
THERMACLEAR
K060653 · GEX
Dermacare, Inc.
General & Plastic Surgery · 225d
Cleared Oct 24, 2006
OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS
K060971 · MEG
Omi Manufacturing Pty., Ltd.
General Hospital · 200d
Cleared Oct 24, 2006
ELECTRODE COATED BALL, MODEL AB302C
K061878 · GEI
E Surgical, LLC
General & Plastic Surgery · 113d
Cleared Oct 24, 2006
KOZY COMFORT INFANT POSITIONER
K062143 · FRP
Alfred E Mann Inst. For Biomedical...
General Hospital · 89d
Cleared Oct 24, 2006
DEPUY PINNACLE ALTRX ACETABULAR CUP LINER
K062148 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 89d
Cleared Oct 24, 2006
CATALYSY
K062660 · IOR
Ki Mobility, LLC
Physical Medicine · 47d
Cleared Oct 24, 2006
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
K062665 · MSH
Inovel, LLC
General Hospital · 47d
Cleared Oct 24, 2006
GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES
K062672 · ETD
Grace Medical, Inc.
Ear, Nose, Throat · 46d
Cleared Oct 24, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEN - TICARCILLIN-CLAVULANATE (GN) 1/2 -...
K062687 · LON
Becton, Dickinson & CO
Microbiology · 46d
Cleared Oct 24, 2006
MODIFICATION TO STRYKER SPINE OASYS SYSTEM
K062853 · MNI
Stryker Spine
Orthopedic · 29d
Cleared Oct 24, 2006
MIDDLE WHEEL DRIVE POWER CHAIR, CWD01
K062888 · ITI
Emg Technology Co., Ltd.
Physical Medicine · 28d
Cleared Oct 24, 2006
MICROENDOSCOPE
K063078 · EOB
Acclarent, Inc.
Ear, Nose, Throat · 14d
Cleared Oct 23, 2006
KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE
K060414 · GAW
Kmi Kolster Methods, Inc.
General & Plastic Surgery · 249d
Cleared Oct 23, 2006
SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
K061188 · MCW
Foxhollow Technologies, Inc.
Cardiovascular · 178d
Cleared Oct 23, 2006
BARD COMPOSITE L/P MESH
K061754 · FTL
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery · 124d
Cleared Oct 23, 2006
INNOVACON HCG UKTRA TEST DEVICE
K062361 · JHI
Innovacon, Inc.
Chemistry · 70d
Cleared Oct 23, 2006
MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH
K062446 · DYB
Terumo Medical Corp.
Cardiovascular · 62d