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
137281–137304 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 11, 1988
NOVA STAT PROFILE 5 ANALYZER + QUALITY CONTROL
K874832 · JGS
Nova Biomedical Corp.
Chemistry · 79d
Cleared Feb 11, 1988
T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE
K874866 · KLI
Serono Diagnostics, Inc.
Chemistry · 76d
Cleared Feb 11, 1988
MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)
K874903 · JPZ
Simmler, Inc.
Chemistry · 72d
Cleared Feb 11, 1988
IRON PROCEDURE
K874918 · JIY
Data Medical Associates, Inc.
Chemistry · 70d
Cleared Feb 11, 1988
STRYKER 1990 LIBERTY ELECTRIC CRITICAL CARE BED
K875037 · FNL
Stryker Corp.
General Hospital · 66d
Cleared Feb 11, 1988
EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628
K875062 · GJS
Em Diagnostic Systems, Inc.
Hematology · 64d
Cleared Feb 11, 1988
IMMPULSE T4 ASSAY REAGENTS
K875081 · CDX
Sclavo, Inc.
Toxicology · 64d
Cleared Feb 11, 1988
MEDICRAT, HYPODERMIC SYRINGES & NEEDLES
K875148 · FMF
Knowltech Ind., Inc.
General Hospital · 58d
Cleared Feb 11, 1988
DISPOSABLE CORONARY CONTROL SYRINGE 12CC
K875196 · DXT
Merit Medical Systems, Inc.
Cardiovascular · 56d
Cleared Feb 11, 1988
REVISED LABELING FOR ADX OPIATES
K880010 · DJG
Abbott Laboratories
Toxicology · 38d
Cleared Feb 11, 1988
REVISED LABELING FOR ADX PHENCYCLIDINE
K880011 · LCL
Abbott Laboratories
Toxicology · 38d
Cleared Feb 11, 1988
REVISIED LABELING FOR ADX BENZODIAZEPINES
K880014 · JXM
Abbott Laboratories
Toxicology · 38d
Cleared Feb 11, 1988
MEDEX MACHINE
K880032 · ISD
Medex, Inc.
Physical Medicine · 37d
Cleared Feb 11, 1988
LEECO PREGNASTICK (EIA) CATALOG #003
K880069 · LCX
Leeco Diagnostics, Inc.
Chemistry · 31d
Cleared Feb 11, 1988
UREA NITROGEN (BUN)
K880078 · CDQ
Tech-Neal Scientific, Inc.
Chemistry · 31d
Cleared Feb 11, 1988
FINNIGAN MAT TSQ-70
K880089 · DOP
Finnigan Corp.
Chemistry · 30d
Cleared Feb 11, 1988
REGANES DISPOSABLE EPIDURAL ANESTHESIA TRAY
K880181 · CAZ
Reganes, Inc.
Anesthesiology · 27d
Cleared Feb 11, 1988
MALLEABLE PTFE COATED BRAIN SPATULAE
K880278 · HAO
Downs Surgical , Ltd.
Neurology · 20d
Cleared Feb 10, 1988
COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1
K874873 · DHN
Diagnostic Products Corp.
Immunology · 72d
Cleared Feb 10, 1988
LIPOGEN ANA TEST KIT
K875246 · LJM
Lipogen, Inc.
Immunology · 50d
Cleared Feb 10, 1988
QM300 ALPHA1-ANTITRYPSIN ANTIBODY PACK
K875281 · DEM
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 48d
Cleared Feb 10, 1988
QM2/QM300 CONTROL B PACK
K875283 · DEM
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 48d
Cleared Feb 10, 1988
IMMUNOGLOBULIN G & G SUBCLASSES
K875356 · DEW
Birmingham
Immunology · 41d
Cleared Feb 10, 1988
INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST
K880148 · KTN
Ampcor, Inc.
Immunology · 28d