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
165145–165168 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 25, 1981
BIO CARE OXYGEN CONCENTRATOR
K810272 · CAW
The Biomed Group
Anesthesiology · 23d
Cleared Feb 25, 1981
UROLOGICAL CATHETERS
K810281 · KOD
Latex Ind., Inc.
Gastroenterology & Urology · 23d
Cleared Feb 25, 1981
CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST
K810301 · DHN
Immuno Concepts, Inc.
Immunology · 21d
Cleared Feb 25, 1981
QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM
K810302 · CEP
Bio-Rad
Chemistry · 20d
Cleared Feb 25, 1981
MODEL LC-85 UV DETECTOR
K810304 · LDM
The Perkin-Elmer Corp.
Toxicology · 20d
Cleared Feb 25, 1981
LIQUID SCINTILLATION SPECTROPHOTOMETER
K810345 · JJJ
Beckman Instruments, Inc.
Chemistry · 15d
Cleared Feb 23, 1981
TRIAXIAL
K802348 · JDB
Johnson & Johnson Professionals, Inc.
Orthopedic · 151d
Cleared Feb 23, 1981
INSPIRON PULMONARY FUNCTION ANALYZER
K802920 · BZC
C.R. Bard, Inc.
Anesthesiology · 97d
Cleared Feb 23, 1981
PACING SYSTEM ANALYZER
K803313 · DTE
Medtronic Vascular
Cardiovascular · 54d
Cleared Feb 23, 1981
UNIFOCAL 3
K810121 · DXY
American Pacemaker Corp.
Radiology · 35d
Cleared Feb 23, 1981
VISIO-BAND
K810265 · KLE
Espe-Premier Sales Co.
Dental · 21d
Cleared Feb 23, 1981
ETCHING GEL
K810266 · EJK
Espe-Premier Sales Co.
Dental · 21d
Cleared Feb 23, 1981
DENTURE CLEANER
K810279 · EFT
Mcdennan Oral Products, Inc.
Dental · 21d
Cleared Feb 23, 1981
SURGIKOS FACE MASK
K810316 · FXX
Surgikos, Inc.
General Hospital · 17d
Cleared Feb 23, 1981
CM 3
K810348 · CBP
Instrumentation Industries, Inc.
Anesthesiology · 13d
Cleared Feb 23, 1981
RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE
K810351 · CDP
Endocrine-Metabolic Center
Chemistry · 13d
Cleared Feb 23, 1981
HARRIS CEMENT RESTRICTOR
K810353 · LZN
Cintor Orthopaedic Div.
Orthopedic · 13d
Cleared Feb 23, 1981
PERCUSS-O-FLEX FOOT & HAND MASSAGER
K810354 · ISA
Modern Reflexology, Inc.
Physical Medicine · 13d
Cleared Feb 23, 1981
ALT (UV) TEST
K810355 · CKA
Boehringer Mannheim Corp.
Chemistry · 13d
Cleared Feb 23, 1981
BICARBONATE TEST
K810356 · KHS
Boehringer Mannheim Corp.
Chemistry · 13d
Cleared Feb 23, 1981
AST (UV) TEST
K810390 · CIT
Boehringer Mannheim Corp.
Chemistry · 13d
Cleared Feb 19, 1981
VARIAN V3500 PHASED ARRAY ULTRASONOGRAPH
K802434 · IYO
Varian Assoc., Inc.
Radiology · 136d
Cleared Feb 19, 1981
CORDIS DOW C-DAK 1.8MRC ARTIFIC-KIDNEY
K802894 · FJI
Cordis Corp.
Gastroenterology & Urology · 94d
Cleared Feb 19, 1981
BRIGHAM TOTAL ANKLE PROSTHESIS
K803167 · HSN
Howmedica Corp.
Orthopedic · 66d