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
158257–158280 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 1983
HI-LO RADIOLOGICAL STRETCHER
K837183
Elscint, Inc.
Radiology · 29d
Cleared Mar 16, 1983
MEDTRONIC MODELS 59401 5941
K823831 · DXY
Medtronic Vascular
Cardiovascular · 85d
Cleared Mar 16, 1983
PACEMAKER ELECTRODE PERM. & TEMP
K830464 · DTB
Daig Corp.
Cardiovascular · 29d
Cleared Mar 16, 1983
CATHETER CONNECTION W/INTEGRAL INJECTATE
K830523 · DQO
Gould, Inc.
Cardiovascular · 27d
Cleared Mar 15, 1983
SPLIT COLON STIFFENING TUBE
K830247 · FED
Keymed, Inc.
Gastroenterology & Urology · 49d
Cleared Mar 14, 1983
MODEL 2100 FETAL MONITOR
K837102
Huntleigh Group , Ltd.
Radiology · 66d
Cleared Mar 11, 1983
VARIOUS CARDIOVASCULAR PRODUCTS
K823357 · DQO
C.R. Bard, Inc.
Cardiovascular · 126d
Cleared Mar 11, 1983
FERRITIN IMMUNORADIOMETRIC ASSAY KIT
K823829 · DFB
Bd Becton Dickinson Vacutainer...
Chemistry · 81d
Cleared Mar 11, 1983
CAPD COLOR-GUARD SYSTEM PREPKIT
K830002 · FKY
Abbott Laboratories
Gastroenterology & Urology · 67d
Cleared Mar 11, 1983
HOLDER FOR BOS-2S INFANT BUBBLE OXYGENA-
K830167 · KRI
American Bentley
Cardiovascular · 52d
Cleared Mar 11, 1983
SKIN SCRUB PREP. TRAY
K830281 · FRG
Zoa, Inc.
General Hospital · 44d
Cleared Mar 11, 1983
ESOPHAGEAL STETHOSCOPE
K830329 · BZW
Science Development Corp.
Anesthesiology · 38d
Cleared Mar 11, 1983
PEEPER
K830395 · BYE
Dupaco, Inc.
Anesthesiology · 32d
Cleared Mar 11, 1983
CONTOX DURG CONTROL
K830492 · DIF
Kaulson Laboratories, Inc.
Toxicology · 23d
Cleared Mar 11, 1983
CONTOX DRUG SCREEN CONTROL
K830494 · DIF
Kaulson Laboratories, Inc.
Toxicology · 23d
Cleared Mar 11, 1983
MODEL 4100 MICROSURGICAL CO2 LASER SYSTEM
K837110
Bio Quantum Technologies, Inc.
Radiology · 63d
Cleared Mar 10, 1983
NO-BOIL SOLID PHASE SIMUL TRAC B12
K822721 · CDD
Bd Becton Dickinson Vacutainer...
Chemistry · 184d
Cleared Mar 10, 1983
PATCH
K823345 · DXZ
Shiley, Inc.
Cardiovascular · 122d
Cleared Mar 10, 1983
CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC
K823863 · DXY
Intermedics, Inc.
Cardiovascular · 78d
Cleared Mar 10, 1983
MICRO FITNESS COMPUTER
K830003 · DXG
Microfit, Inc.
Cardiovascular · 66d
Cleared Mar 10, 1983
RICH-MAR HV 20
K830055 · IPF
Rich-Mar Corp.
Physical Medicine · 57d
Cleared Mar 10, 1983
PHADEBAS & PHADEZYM RAST ALLERGEN DISCS
K830155 · DHB
Pharmacia, Inc.
Chemistry · 51d
Cleared Mar 10, 1983
DIGIFLEX AUTOMATIC PIPETTE
K830157 · JQW
Micromedic Systems
Chemistry · 51d
Cleared Mar 10, 1983
AUTOMATED ELISA READER LBI 300
K830227 · JTQ
Bionetic Laboratory Products
Chemistry · 45d