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
62593–62616 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 2006
SERVICE MANAGER SM40SE
K053464 · FYD
Conmed Integrated Systems, Canada, Ulc
General Hospital · 175d
Cleared Jun 06, 2006
OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S):...
K060201 · DHR
Olympus America, Inc.
Immunology · 131d
Cleared Jun 06, 2006
ART BRACHYTHERAPY APPLICATOR
K060299 · JAQ
Advanced Radiation Therapy, LLC
Radiology · 120d
Cleared Jun 06, 2006
BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166
K060375 · GKZ
Bd Biosciences
Hematology · 113d
Cleared Jun 06, 2006
CONFIDOSE IM AUTO-INJECTOR
K060389 · KZH
Pharma-Pen, Inc.
General Hospital · 112d
Cleared Jun 06, 2006
HEMA SCREEN SPECIFIC IFOBT
K060463 · KHE
Immunostics Inc.,
Hematology · 104d
Cleared Jun 06, 2006
K-SHIELD PORT ACCESS INFUSION SET
K060580 · FPA
Kawasumi Laboratories, Inc.
General Hospital · 92d
Cleared Jun 06, 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE...
K060632 · NBC
Ortho-Clinical Diagnostics, Inc.
Chemistry · 89d
Cleared Jun 06, 2006
FASTIN RC ANCHOR
K060664 · HWC
Depuy Mitek
Orthopedic · 85d
Cleared Jun 06, 2006
MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR
K060693 · HWC
Arthrotek, Inc.
Orthopedic · 83d
Cleared Jun 06, 2006
SILKLINE SOFT RELINING KIT, MODEL 28-100100
K060844 · EBI
J. Morita USA, Inc.
Dental · 70d
Cleared Jun 06, 2006
TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS...
K060963 · LXC
Twin Star Medical
Orthopedic · 60d
Cleared Jun 06, 2006
TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS
K061019 · JDS
Smith & Nephew, Inc.
Orthopedic · 54d
Cleared Jun 06, 2006
CTS-7700
K061083 · IYO
Shantou Institute of Ultrasonic...
Radiology · 49d
Cleared Jun 06, 2006
WDS, SIZE 2 AND SIZE 2
K061114 · MUH
Cefla S.C.R.L.
Radiology · 46d
Cleared Jun 06, 2006
MUCOGRAFT
K061244 · NPL
Ed. Geistlich Soehne AG Fuer...
Dental · 34d
Cleared Jun 06, 2006
36MM BIOLOX DELTA CERAMIC HEADS
K061312 · LZO
Biomet, Inc.
Orthopedic · 27d
Cleared Jun 06, 2006
MODIFICATION TO ENDIUS ATAVI SYSTEM
K061345 · HRX
Endius, Inc.
Orthopedic · 22d
Cleared Jun 06, 2006
LORENZ PECTUS SUPPORT BAR, TITANIUM
K061384 · HRS
Walter Lorenz Surgical, Inc.
Orthopedic · 19d
Cleared Jun 05, 2006
GLUCOPACK
K052469 · NBW
Healthpia America Corp.
Chemistry · 270d
Cleared Jun 05, 2006
B&L L-BETA, MODEL WL-B1
K060347 · EKR
B&L Biotech Co., Ltd.
Dental · 115d
Cleared Jun 05, 2006
GE DATEX-OHMEDA ENGSTROM CARESTATION
K060862 · CBK
Datex-Ohmeda, Inc.
Anesthesiology · 68d
Cleared Jun 05, 2006
MODEL MI 44 TYMPANOMETER
K060885 · EWO
Maico-Diagnostics
Ear, Nose, Throat · 66d
Cleared Jun 05, 2006
BRILLIANCE VOLUME
K060937 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 61d