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
61057–61080 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 2006
EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD
K062684 · LZO
Aesculap, Inc.
Orthopedic · 75d
Cleared Nov 22, 2006
ADJUST-RIGHT FIXATION DEVICES
K062734 · JDR
Valpo Orthopedic Technology, Inc.
Orthopedic · 70d
Cleared Nov 22, 2006
PTW DAVID IMRT QC VERIFICATION SYSTEM
K062817 · IYE
Ptw-New York Corp.
Radiology · 63d
Cleared Nov 22, 2006
CALCIUM
K062855 · CJY
Abbott Laboratories
Chemistry · 58d
Cleared Nov 22, 2006
KLS MARTIN QUICK DISC
K062857 · GXN
KLS-Martin L.P.
Neurology · 58d
Cleared Nov 22, 2006
ACTIVASCREW
K062980 · HWC
Bioretec, Ltd.
Orthopedic · 54d
Cleared Nov 22, 2006
IVUS ENHANCER
K062985 · LLZ
Indec Systems, Inc.
Radiology · 54d
Cleared Nov 22, 2006
PROFILER 2
K063021 · IYE
Sun Nuclear Corp.
Radiology · 51d
Cleared Nov 22, 2006
MODIFICATION TO ACUSON ANTARES ULTRASOUND SYSTEM
K063138 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 37d
Cleared Nov 22, 2006
MODIFICATION TO EXPEDIUM SPINE SYSTEM
K063156 · NKB
Depuy Spine, Inc.
Orthopedic · 36d
Cleared Nov 22, 2006
CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM
K063212 · NBW
Taidoc Technology Corporation
Chemistry · 30d
Cleared Nov 22, 2006
XPLORER 1500 DIGITAL RADIOGRAPHIC SYSTEM WITH STAND
K063246 · KPR
Imaging Dynamics Company , Ltd.
Radiology · 27d
Cleared Nov 22, 2006
XPLORER 1800 DIGITAL RADIOGRAPHIC SYSTEM WITH UNIVERSAL STAND
K063247 · KPR
Imaging Dynamics Company , Ltd.
Radiology · 27d
Cleared Nov 22, 2006
FMP COATED SPIKED ACETABULAR CUP
K063257 · LPH
Encore Medical, L.P.
Orthopedic · 26d
Cleared Nov 22, 2006
PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK...
K063273 · JDR
Depuy Miltek, A Johnson & Johnson Co.
Orthopedic · 23d
Cleared Nov 22, 2006
UNIVERSAL LOCKING SYSTEM, 2.7MM PLATES & SCREWS
K063303 · HRS
Zimmer, Inc.
Orthopedic · 21d
Cleared Nov 22, 2006
ORTHOVIEW
K063327 · LLZ
Merdian Technique, Ltd.
Radiology · 19d
Cleared Nov 22, 2006
ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY
K063330 · MTJ
Orthocon, Inc.
General & Plastic Surgery · 19d
Cleared Nov 22, 2006
DX-SI
K063421 · MQB
Agfa Corp.
Radiology · 9d
Cleared Nov 21, 2006
MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU
K050263 · FLE
M.O. Com S.R.L.
General Hospital · 655d
Cleared Nov 21, 2006
ONCOBIONIC SYSTEM
K060054 · OAB
Oncobionics, Inc.
General & Plastic Surgery · 319d
Cleared Nov 21, 2006
CADWELL EASYNET NASAL PRESSURE MODULE
K061705 · MNR
Cadwell Laboratories, Inc.
Anesthesiology · 158d
Cleared Nov 21, 2006
FIDIS TM THYRO, MODEL MX002
K061794 · JZO
Biomedical Diagnostics (Bmd) SA
Immunology · 148d
Cleared Nov 21, 2006
STIMUPLEX PEN
K061983 · BXN
Stockert GmbH
Anesthesiology · 131d