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
57913–57936 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 12, 2007
ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114
K072660 · DZE
Imtec Corp.
Dental · 82d
Cleared Dec 12, 2007
DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210
K072717 · JIT
Dade Behring, Inc.
Chemistry · 78d
Cleared Dec 12, 2007
PASSEO 18
K072765 · LIT
Biotronik, Inc.
Cardiovascular · 75d
Cleared Dec 12, 2007
COMPREHENSIVE RS SHOULDER SYSTEM
K072804 · PHX
Biomet Manufacturing Corp
Orthopedic · 72d
Cleared Dec 12, 2007
ELITE GLASS
K073005 · ELW
Zhermack S.P.A.
Dental · 49d
Cleared Dec 12, 2007
MODIFICATION TO: T-PORT HP INFUSION PORT
K073210 · LJT
Pfm Medical, Inc.
General Hospital · 28d
Cleared Dec 12, 2007
MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEM
K073248 · HSX
Mako Surgical Corp.
Orthopedic · 23d
Cleared Dec 12, 2007
SMARTLIPO LASER
K073394 · GEX
Cynosure, Inc.
General & Plastic Surgery · 9d
Cleared Dec 11, 2007
D3 HEMATOLOGY ANALYZER, MODEL D3
K071562 · GKZ
Drew Scientific, Inc.
Hematology · 187d
Cleared Dec 11, 2007
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K071942 · KWP
Medtronic Sofamor Danek
Orthopedic · 151d
Cleared Dec 11, 2007
VERIFY V-PRO CHEMICAL INDICATOR, VERSIONS 1 AND 2
K072510 · JOJ
STERIS Corporation
General Hospital · 96d
Cleared Dec 11, 2007
DIVO
K072637 · LLZ
A2d Imaging, LLC
Radiology · 84d
Cleared Dec 11, 2007
LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC
K072721 · DIF
Bio-Rad, Diagnostics Grp.
Chemistry · 76d
Cleared Dec 11, 2007
PVMED DDR 2520 DIGITAL IMAGING SYSTEM
K072766 · IXK
Portavision Medical
Radiology · 74d
Cleared Dec 11, 2007
LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK
K072835 · JJY
Bio-Rad, Diagnostics Grp.
Chemistry · 69d
Cleared Dec 11, 2007
WORKSTATIONONE BREAST IMAGING WORKSTATION
K073272 · LLZ
Three Palm Software, LLC
Radiology · 20d
Cleared Dec 11, 2007
EQUAL DOSE 1.0
K073273 · IYE
Nucletron Corporation
Radiology · 20d
Cleared Dec 10, 2007
IMPIX SPACER
K072226 · MAX
Medicrea Technologies
Orthopedic · 122d
Cleared Dec 10, 2007
TOTAL HIP SURGETICS NAVIGATION SYSTEM
K072267 · HAW
Praxim S.A
Neurology · 117d
Cleared Dec 10, 2007
CHASE MR SYSTEM
K072473 · LNH
Chase Medical, LP
Radiology · 97d
Cleared Dec 10, 2007
CYTORI AFT SYSTEM
K072587 · MUU
Cytori Therapeutics, Inc.
General & Plastic Surgery · 87d
Cleared Dec 10, 2007
OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT
K072601 · GXP
Osteosymbionics, LLC
Neurology · 87d
Cleared Dec 10, 2007
TWINFIX FT PK
K072785 · HWC
Smith & Nephew Inc., Endoscopy Division
Orthopedic · 70d
Cleared Dec 10, 2007
ICE-SENSE
K072883 · GEH
Arbel Medical , Ltd.
General & Plastic Surgery · 62d