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
57721–57744 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 04, 2008
VITALLINK3 MOBILE VITAL SIGNS SYSTEM
K073094 · MWI
Telemedic Systems, Ltd.
Cardiovascular · 64d
Cleared Jan 04, 2008
BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER
K073167 · LNH
Ge Medical Systems, LLC
Radiology · 56d
Cleared Jan 04, 2008
CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231
K073336 · HBF
Codman & Shurtleff, Inc.
Neurology · 37d
Cleared Jan 04, 2008
LIFE SPINE CROSS CONNECTOR
K073480 · NKB
Life Spine
Orthopedic · 24d
Cleared Jan 03, 2008
DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS
K072395 · LBS
Diazyme Laboratories
Chemistry · 129d
Cleared Jan 03, 2008
DIGIFLO CONCENTRATOR ANALYZER
K072469 · CCL
Digiflo, Inc.
Anesthesiology · 121d
Cleared Jan 03, 2008
NATURAL BRIDGE LP TRANSVERSE CONNECTORS
K072914 · MNI
K2m, Inc.
Orthopedic · 83d
Cleared Jan 03, 2008
DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270
K073055 · JFY
Dade Behring, Inc.
Chemistry · 65d
Cleared Jan 03, 2008
PEEK SPINAL SPHERES
K073105 · NVR
Interbody Innovations, Llp
Orthopedic · 62d
Cleared Jan 03, 2008
INFINITY PICCO POD, MODEL MS16734
K073113 · DXG
Draeger Medical Systems, Inc.
Cardiovascular · 59d
Cleared Jan 03, 2008
SYNGO VOLUME PERFUSION-CT NEURO
K073238 · JAK
Siemens AG Medical Solutions
Radiology · 48d
Cleared Jan 03, 2008
PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400
K073242 · CAW
Delphi Medical Systems
Anesthesiology · 45d
Cleared Jan 03, 2008
H-LINK INTEGRATED ROD
K073517 · NKB
Globus Medical, Inc.
Orthopedic · 20d
Cleared Jan 02, 2008
COOLTOUCH MODELS NS 160 AND LC215 COOLIPO
K072751 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 97d
Cleared Jan 02, 2008
MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP
K073313 · GEX
Omniguide, Inc.
General & Plastic Surgery · 37d
Cleared Dec 31, 2007
EUROIMMUN ANTI-CCP ELISA
K070789 · NHX
Euroimmun Us, LLC
Immunology · 284d
Cleared Dec 31, 2007
KENSEY NASH MACROPORE SHIELD
K071695 · FTL
Kensey Nash Corp.
General & Plastic Surgery · 194d
Cleared Dec 28, 2007
AEROSOL SYSTEM
K063716 · CAF
Amici, Inc.
Anesthesiology · 379d
Cleared Dec 28, 2007
FLEXCATH STEERABLE SHEATH & DILATOR
K070357 · DRA
Cryocath Technologies, Inc.
Cardiovascular · 324d
Cleared Dec 28, 2007
NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM
K070857 · DZE
Nobel Biocare AB
Dental · 275d
Cleared Dec 28, 2007
SCANSCOPE XT SYSTEM
K071671 · OEO
Aperio Technologies
Pathology · 192d
Cleared Dec 28, 2007
POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
K071905 · KWQ
Lanx, LLC
Orthopedic · 171d
Cleared Dec 28, 2007
ALARIS SYSTEM WITH MMS, MODEL 8XXX
K072105 · FRN
Cardinal Health 303,Inc.
General Hospital · 150d
Cleared Dec 28, 2007
ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM &...
K072528 · JEY
Prosurg, Inc.
Dental · 112d