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
61897–61920 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 2006
KSEA BIPOLAR ELECTROTOME
K061541 · FAS
Ksea
Gastroenterology & Urology · 77d
Cleared Aug 21, 2006
BIOPRO MEMORY STAPLE
K061798 · JDR
Biopro, Inc.
Orthopedic · 56d
Cleared Aug 21, 2006
DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110
K061838 · JIX
Dade Behring, Inc.
Chemistry · 53d
Cleared Aug 21, 2006
NOVAPACS, NOVAVIEW, NOVACARDIO, NOVAQC AND NOVAER
K061920 · LLZ
Novarad Corp.
Radiology · 46d
Cleared Aug 21, 2006
LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000
K061941 · IWB
Elekta Instrument AB
Radiology · 42d
Cleared Aug 21, 2006
THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS
K062128 · JHS
Dade Behring, Inc.
Chemistry · 26d
Cleared Aug 21, 2006
UNI KNEE SURGETICS NAVIGATION SYSTEM
K062146 · HAW
Praxim S.A
Neurology · 25d
Cleared Aug 21, 2006
DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS...
K062191 · DIF
Dade Behring, Inc.
Toxicology · 21d
Cleared Aug 21, 2006
DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
K062236 · MKW
Dade Behring, Inc.
Chemistry · 19d
Cleared Aug 21, 2006
VITREAACCESS, VERSION 1.0
K062328 · LLZ
Vital Images, Inc.
Radiology · 11d
Cleared Aug 21, 2006
Z-BLOCK, MODELS 20/19, 40/19, 55/19
K062389 · EIH
Foundation Milling Centre
Dental · 5d
Cleared Aug 18, 2006
ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.
K060657 · BZD
Breas Medical AB
Anesthesiology · 158d
Cleared Aug 18, 2006
ADVANCE TOTAL KNEE SYSTEM
K061223 · MBH
Wrightmedicaltechnologyinc
Orthopedic · 108d
Cleared Aug 18, 2006
LD-578 FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K061279 · DXN
Little Doctor (Shanghai) Electronic
Cardiovascular · 102d
Cleared Aug 18, 2006
INTERPLATE VBR SYSTEM
K061401 · MQP
Rsb Spine, LLC
Orthopedic · 91d
Cleared Aug 18, 2006
SONOMARK
K061560 · ITX
Medical Products Manufacturing, Inc.
Radiology · 74d
Cleared Aug 18, 2006
EXCIA
K061699 · LWJ
Aesculap, Inc.
Orthopedic · 63d
Cleared Aug 18, 2006
COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA
K061736 · BTT
Teleflex Medical
Anesthesiology · 59d
Cleared Aug 18, 2006
GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR...
K061853 · ETB
Grace Medical, Inc.
Ear, Nose, Throat · 49d
Cleared Aug 18, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM (GP)...
K061869 · LON
Becton, Dickinson & CO
Microbiology · 46d
Cleared Aug 18, 2006
VERT-X
K061873 · OXO
Direx Systems Corp.
Radiology · 46d
Cleared Aug 18, 2006
SYNEX II
K061891 · MQP
Synthes Spine Co.Lp
Orthopedic · 46d
Cleared Aug 18, 2006
RELIEVA SINUS BALLOON CATHETER
K061903 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 44d
Cleared Aug 18, 2006
FOLEY CATHETERS WITH TEMPERATURE PROBE
K061918 · EYC
Ge Healthcare
Gastroenterology & Urology · 43d