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
165313–165336 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 02, 1981
ASSAY STRIPS
K803244 · JTC
Corning Costar Corp.
Microbiology · 41d
Cleared Feb 02, 1981
SENSOMAT MUSCLE/TISSUE PH
K803260 · CBZ
Biochem International, Inc.
Anesthesiology · 40d
Cleared Feb 02, 1981
GUARDIAN STERILIZATION WRAP
K803294 · FRG
Kimberly-Clark Corp.
General Hospital · 34d
Cleared Feb 02, 1981
TOMOMATIC 64
K810006 · IZD
Medimatic
Radiology · 28d
Cleared Feb 02, 1981
SELECTRON REMOTE ISOTOPE
K810051 · JAQ
Victoreen, Inc.
Radiology · 34d
Cleared Feb 02, 1981
STANBIO BILIRUBIN TEST SET
K810055 · CIG
Stanbio Laboratory
Chemistry · 20d
Cleared Feb 02, 1981
STERILE AIRWAY
K810069 · CAE
Medspec Corp.
Anesthesiology · 20d
Cleared Feb 02, 1981
Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S
K810078 · DIF
Hyland Therapeutic Div., Travenol...
Chemistry · 20d
Cleared Feb 02, 1981
CHOLESTEROL STANDARD
K810092 · JIS
Anco Medical Reagents & Assoc.
Chemistry · 20d
Cleared Feb 02, 1981
EMIT-ST PHENCYCLIDINE ASSAY
K810093 · LCM
Syva Co.
Toxicology · 20d
Cleared Feb 02, 1981
DENTURE RUBBER BASE MATERIAL
K810094 · EBI
Bosworth Co.
Dental · 19d
Cleared Feb 02, 1981
BCA 1000
K810105 · JJQ
Biodynamics Corp.
Chemistry · 17d
Cleared Feb 02, 1981
SHILEY SINGLE CANNULA TRACHEOSTOMY TUBE
K810106 · BTO
Shiley, Inc.
Anesthesiology · 17d
Cleared Feb 02, 1981
CENTRIFICHEM SYSTEM 500
K810129 · JJE
Union Carbide Corp.
Chemistry · 14d
Cleared Feb 02, 1981
URIC ACID REAGENT SYSTEM
K810136 · KNK
American Monitor Corp.
Chemistry · 12d
Cleared Feb 02, 1981
ALK-PHOS BIOPAK GEL
K810144 · CIN
Bioware Products
Chemistry · 12d
Cleared Feb 02, 1981
TEMPERATURE FUNCTION BLOCK
K810173 · FLL
Honeywell, Inc.
General Hospital · 11d
Cleared Jan 30, 1981
SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS
K810079 · KRI
3M Health Care, Sarns
Cardiovascular · 17d
Cleared Jan 29, 1981
K/K (ASMA/ANA) UNIVERSAL BIOPAK
K802299 · DHN
Bioware Products
Immunology · 132d
Cleared Jan 29, 1981
EXTRACORPOREAL'S EXP 400 PARALLEL PLATE
K802364 · FJG
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 122d
Cleared Jan 29, 1981
RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL
K803133 · LFX
Microbiological Research Corp.
Microbiology · 48d
Cleared Jan 29, 1981
TOXOPLASMA GONDII SEROLOGICAL REAGENTS
K803134 · GLZ
Microbiological Research Corp.
Microbiology · 48d
Cleared Jan 29, 1981
RUBELLA VIRUS SEROLOGICAL REAGENTS
K803175 · LFX
Microbiological Research Corp.
Microbiology · 45d
Cleared Jan 29, 1981
FIELD SUCTION DISSECTOR
K803292 · GDI
V. Mueller O.V. Baxter Healthcare Corp.
General & Plastic Surgery · 30d