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
141361–141384 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 1987
QAD-1 ANGIODYNOGRAPH ULTRASOUND SYSTEM
K860581 · IYO
Quantum Medical Systems, Inc.
Radiology · 360d
Cleared Feb 13, 1987
ACUSON S519B TRANSDUCER
K863236
Acuson Computed Sonography
Gastroenterology & Urology · 176d
Cleared Feb 13, 1987
IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT
K863868 · DFF
Cooper Biomedical, Inc.
Immunology · 133d
Cleared Feb 13, 1987
UTISCREEN(R) BACTERIAL ATP TEST
K864202 · JXA
Los Alamos Diagnostics
Microbiology · 109d
Cleared Feb 13, 1987
IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO
K864512 · DAD
Cooper Biomedical, Inc.
Immunology · 92d
Cleared Feb 13, 1987
PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR)
K864519 · LLZ
Parexel Intl. Corp.
Radiology · 88d
Cleared Feb 13, 1987
VAC - RITE RIGHT ANGLE ASPIRATOR TUBE & HOLDER
K864621 · EHZ
Seldoren , Ltd.
Dental · 81d
Cleared Feb 13, 1987
MODIFICATION (MATERIAL CHANGE) OF PEEL-AWAY SHEATH
K864705 · DYB
Quinton, Inc.
Cardiovascular · 73d
Cleared Feb 13, 1987
WAKO (TM) AUTOKIT GOT TEST
K864813 · CIT
Wako Chemicals USA, Inc.
Chemistry · 66d
Cleared Feb 13, 1987
INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM
K864861 · EGM
Instrumentations Unltd.
Dental · 64d
Cleared Feb 13, 1987
ELECTRA AUTOMATIC SAMPLER
K864875 · JQW
Medical Laboratory Automation...
Chemistry · 63d
Cleared Feb 13, 1987
DU PONT LIQUID MULTI-ANALYTE CALIBRATOR
K864909 · JIX
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 60d
Cleared Feb 13, 1987
AZTREONAM 30 MCG. SENSI-DISC
K865034 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 52d
Cleared Feb 13, 1987
ASSERA-PLATE PROTEIN S KIT
K870042
American Bioproducts Co.
Hematology · 39d
Cleared Feb 13, 1987
BICARBONATE PROCEDURE
K870062 · KHS
Data Medical Associates, Inc.
Chemistry · 37d
Cleared Feb 13, 1987
PANORAMIC X-RAY MODEL PC-1000
K870236 · EHD
Panoramic Corp.
Radiology · 23d
Cleared Feb 13, 1987
CAT EPITHELIUM ALLERGEN DISC
K870264 · DHB
Incstar Corp.
Immunology · 21d
Cleared Feb 13, 1987
ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202
K870329 · HTR
Biodynamic Technologies, Inc.
General & Plastic Surgery · 16d
Cleared Feb 13, 1987
BIODYNAMICS SMALL JOINT BRUSH #1203
K870333 · HTR
Biodynamic Technologies, Inc.
General & Plastic Surgery · 16d
Cleared Feb 13, 1987
P4802 BEA
K870339 · JSI
Lakewood Biochemical Co., Inc.
Microbiology · 16d
Cleared Feb 13, 1987
Z2017, BEA/CNA 5%SB BIPLATE
K870340 · JSI
Lakewood Biochemical Co., Inc.
Microbiology · 16d
Cleared Feb 13, 1987
P1012 BE AGAR
K870341 · JSI
Lakewood Biochemical Co., Inc.
Microbiology · 16d
Cleared Feb 13, 1987
P3700 COL. CNA W/5% SB
K870342 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 16d
Cleared Feb 13, 1987
BIODYNAMICS FEMORAL CANAL BRUSH #1201
K870349 · HTR
Biodynamic Technologies, Inc.
General & Plastic Surgery · 16d