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

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176,076 results
72049–72072 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 2003
EXCEL PRIMARY SOLUTION SET
K031500 · FPA
Exelint Intl. Co.
General Hospital · 73d
Cleared Jul 25, 2003
S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
K031554 · CAC
Genzyme Biosurgery
Anesthesiology · 67d
Cleared Jul 25, 2003
NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE
K031580 · LZA
Green Prospect Sdn Bhd
General Hospital · 66d
Cleared Jul 25, 2003
MC2X MULTI-STAGE VENOUS CANNULA
K031776 · DWF
Medtronic Perfusion Systems
Cardiovascular · 45d
Cleared Jul 25, 2003
VINYL EXAM GLOVES, POWDER-FREE, YELLOW
K031854 · LYZ
Shanghai Jiawang Industrial Co. , Ltd.
General Hospital · 39d
Cleared Jul 25, 2003
STAINLESS STEEL AQUATIC WHEELCHAIR
K031910 · IOR
Db Perks & Associates , Ltd.
Physical Medicine · 35d
Cleared Jul 25, 2003
STRYKER PLATING SYSTEM PERIARTICULAR PLATES
K031959 · LXT
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jul 25, 2003
CONMED INTEGRATED SYSTEMS NURSES ASSISTANT
K031979 · FSY
Conmed Integrated Systems (Cmis)
General & Plastic Surgery · 29d
Cleared Jul 25, 2003
MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM
K031980 · HAW
Elekta Instrument AB
Radiology · 29d
Cleared Jul 25, 2003
2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445
K031981 · MAI
Linvatec Biomaterials, Ltd.
Orthopedic · 29d
Cleared Jul 25, 2003
ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT
K031999 · HAW
Elekta Instrument AB
Radiology · 28d
Cleared Jul 25, 2003
UC-PLUS SOLUTION UNICONDYLAR KNEE
K032052 · HRY
Plus Orthopedics
Orthopedic · 23d
Cleared Jul 25, 2003
MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
K032059 · KWQ
Aesculap, Inc.
Orthopedic · 23d
Cleared Jul 25, 2003
SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS,...
K032147 · FRN
Alaris Medical Systems, Inc.
General Hospital · 11d
Cleared Jul 25, 2003
GE LOGIQ 7, MODEL 2354858
K032182 · IYN
General Electric Co.
Radiology · 8d
Cleared Jul 24, 2003
MEGATECH SCIENTIFIC FACE MASK
K030239 · FXX
Megatech Scientific Pte, Ltd.
General Hospital · 182d
Cleared Jul 24, 2003
THERIFIL BONE FILLER
K031040 · MQV
Therics, Inc.
Orthopedic · 114d
Cleared Jul 24, 2003
NOBEL DIRECT, MODELS 30937, 30938
K031345 · DZE
Nobel Biocare Uas, Inc.
Dental · 86d
Cleared Jul 24, 2003
NON-STERILE POWDER FREE, LATEX EXAMINATION GLOVES, POLYMER COATED WHITE...
K031581 · LYY
Green Prospect Sdn Bhd
General Hospital · 65d
Cleared Jul 24, 2003
TINNITUS RX
K031624 · KLW
Tinnitus Control, Inc.
Ear, Nose, Throat · 62d
Cleared Jul 24, 2003
VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
K031648 · EOB
Olympus Optical Co., Ltd.
Ear, Nose, Throat · 57d
Cleared Jul 24, 2003
MODIFICATION TO FORTITUDE CEMENT RESTRICTOR
K031837 · JDK
Spinal Concepts, Inc.
Orthopedic · 38d
Cleared Jul 24, 2003
HOFFMANN II COMPACT BALTIMORE COUPLING
K031941 · JEC
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jul 24, 2003
ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS
K031986 · EWO
Ics Medical
Ear, Nose, Throat · 27d