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
38929–38952 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 2014
AXIOM REG
K131066 · DZE
Anthogyr Sas
Dental · 311d
Cleared Feb 21, 2014
MEDLINE BIOPSY VALVE
K131426 · OCX
Medline Industries, Inc.
Gastroenterology & Urology · 280d
Cleared Feb 21, 2014
FREEDOM PCK COMPONENTS
K131481 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 275d
Cleared Feb 21, 2014
POLAROID CONTACTSPOD
K131783 · LRX
Viopti, Ltd.
Ophthalmic · 249d
Cleared Feb 21, 2014
OXYGEN GENERATOR LIQUEFIER - (OGL)
K131990 · CAW
Essex Cryogenics of Missouri, Inc.
Anesthesiology · 238d
Cleared Feb 21, 2014
ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM
K132039 · EQN
Jedmed Instrument Co.
Ear, Nose, Throat · 234d
Cleared Feb 21, 2014
NOVOHIP TOTAL HIP SYSTEM
K132158 · LPH
Novosource, Inc.
Orthopedic · 224d
Cleared Feb 21, 2014
STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT...
K132219 · NHA
Straumann USA, LLC
Dental · 219d
Cleared Feb 21, 2014
OMNI PATENT MONITORS
K132229 · MWI
Infinium Medical
Cardiovascular · 218d
Cleared Feb 21, 2014
SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM
K132402 · DQA
Nonin Medical, Inc.
Anesthesiology · 204d
Cleared Feb 21, 2014
FORA DIAMOND NEXUS MINI INFRARED FOREHEAD THERMOMETER
K132457 · FLL
Biocare Asia Corporation , Ltd.
General Hospital · 199d
Cleared Feb 21, 2014
FLAATZ 600 SERIES (FLAATZ 600/601)
K132842 · MQB
Drtech Corp.
Radiology · 164d
Cleared Feb 21, 2014
LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE...
K132874 · JAQ
Nucletron B.V.
Radiology · 161d
Cleared Feb 21, 2014
ARTISTE SOLUTION WITH SYS_VC10C AND SYNGO RT THERAPIST WORKSPACE, V4.3.1...
K132935 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 156d
Cleared Feb 21, 2014
T-TYPE D-KAT, R-TYPE D-KAT
K133234 · HKY
Keeler Limited
Ophthalmic · 123d
Cleared Feb 21, 2014
DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA
K133409 · MQB
Rayence Co., Ltd.
Radiology · 106d
Cleared Feb 21, 2014
SHERPA PAK CARDIAC TRANSPORT SYSTEM
K133432 · MSB
Paragonix Technologies, Inc.
Gastroenterology & Urology · 108d
Cleared Feb 21, 2014
ADVIA CENTAUR TESTOSTERONE (TSTO)
K133491 · CDZ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 100d
Cleared Feb 21, 2014
EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE...
K133509 · NBW
Biotest Medical Corp.
Chemistry · 99d
Cleared Feb 21, 2014
MONITOR B40
K133576 · MHX
Ge Medical Systems China Co., Ltd.
Cardiovascular · 93d
Cleared Feb 21, 2014
LZI MULTIPLE ANALYTE SET A
K133710 · DKB
Lin-Zhi International, Inc.
Toxicology · 79d
Cleared Feb 21, 2014
BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R)...
K133948 · KNW
Bard Peripheral Vascular, Inc.
Gastroenterology & Urology · 60d
Cleared Feb 20, 2014
ADVANCED PERFUSION SYSTEM 1
K131041 · DTQ
Terumo Cardiovascular Systems Corp.
Cardiovascular · 311d
Cleared Feb 20, 2014
PROINSERT
K131145 · MQK
Nidacon International AB
Obstetrics & Gynecology · 303d