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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
41689–41712 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 24, 2013
HEMOSIL READIPLAS TIN
K122584 · GJS
Instrumentation Laboratory CO
Hematology · 212d
Cleared Mar 24, 2013
AXERA 2 ACCESS SYSTEM
K123618 · DYB
Arstasis, Inc.
Cardiovascular · 121d
Cleared Mar 24, 2013
FIBERLASE ENDURE CO2 FIBER
K130164 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 60d
Cleared Mar 22, 2013
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
K120771 · GKZ
Beckman Coulter, Inc.
Hematology · 373d
Cleared Mar 22, 2013
ALCO-SCREEN
K121247 · DIC
Chematics, Inc.
Chemistry · 331d
Cleared Mar 22, 2013
AXIS-SHIELD ACVTIVE-B12
K121946 · CDD
Axis-Shield Diagnostics, Ltd.
Chemistry · 262d
Cleared Mar 22, 2013
ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM...
K122037 · MAX
Medtronic Sofamor Danek, Inc.
Orthopedic · 254d
Cleared Mar 22, 2013
PROCARE MONITOR B20
K122253 · MHX
Ge Medical Systems China Co., Ltd.
Cardiovascular · 238d
Cleared Mar 22, 2013
MRII CRAINIAL DRILL
K122456 · HBG
Mri Interventions, Inc.
Neurology · 221d
Cleared Mar 22, 2013
ENDOSCOPIC INTRODUCER
K123013 · FED
Novadaq Technologies, Inc.
Gastroenterology & Urology · 175d
Cleared Mar 22, 2013
FEMORAL ACCESS VENOUS CANNULAE
K123303 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 150d
Cleared Mar 22, 2013
BALANCED KNEE SYSTEM HIGH FLEX PS
K123457 · JWH
Ortho Development Corp.
Orthopedic · 134d
Cleared Mar 22, 2013
MORTARA SURVEYOR PATIENT MONITOR
K123556 · MHX
Mortara Instrument, Inc.
Cardiovascular · 123d
Cleared Mar 22, 2013
HEINE MINI 3000 LED OPHTHALMOSCOPE
K123587 · HLJ
Heine Optotechnik GmbH & Co. KG
Ophthalmic · 121d
Cleared Mar 22, 2013
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
K123652 · MAX
Spineology, Inc.
Orthopedic · 115d
Cleared Mar 22, 2013
NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS
K124004 · OLO
Medtronic Navigation, Inc.
Orthopedic · 86d
Cleared Mar 22, 2013
VARIAX 2 COMPRESSION PLATING SYSTEM
K130009 · HRS
Stryker Trauma AG
Orthopedic · 79d
Cleared Mar 22, 2013
S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)
K130141 · CJE
Hitachi Chemical Diagnostics, Inc.
Chemistry · 59d
Cleared Mar 22, 2013
DIMENSION EXL WITH LM SYSTEM
K130276 · JJE
Siemens Healthcare Diagnostics, Inc.
Chemistry · 45d
Cleared Mar 22, 2013
CAIMAN SEAL AND CUT TECHNOLOGY
K130596 · GEI
Aesculap, Inc.
General & Plastic Surgery · 15d
Cleared Mar 21, 2013
SHENZHEN MED-LINK PULSE OXIMETER PROBE
K113727 · DQA
Shenzhen Med-Link Electronics Tech...
Anesthesiology · 458d
Cleared Mar 21, 2013
BETA-TCP GRANULES
K120354 · MQV
Skeletal Kinetics, LLC
Orthopedic · 409d
Cleared Mar 21, 2013
ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1
K121772 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 279d
Cleared CT Mar 21, 2013
XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP...
K121894 · PCH
Luminex Molecular Diagnostics, Inc.
Microbiology · 265d