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
152257–152280 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 27, 1984
SERVOCARD SCP-840
K842312 · LDD
Litton Datamedix
Cardiovascular · 76d
Cleared Aug 27, 1984
ELECATH INFANT ARTERIAL & VENOUS CANNU
K842369 · BWF
Electro-Catheter Corp.
Anesthesiology · 73d
Cleared Aug 27, 1984
CARDIOTOMY RESERVOIR W/FILTER BCR-3500
K842620 · DTN
American Bentley
Cardiovascular · 53d
Cleared Aug 27, 1984
CARDIAC SUPPLY TRAY
K842645 · DQY
Deroyal Industries, Inc.
Cardiovascular · 48d
Cleared Aug 27, 1984
EXTERNAL PEDIATRIC DEFIBRILLATOR PADDLE
K842667 · LDD
Marquette Electronics, Inc.
Cardiovascular · 48d
Cleared Aug 27, 1984
BAIM CORONARY SINUS FLOW CALCULATOR
K842831 · DXG
Electro-Catheter Corp.
Cardiovascular · 38d
Cleared Aug 27, 1984
ARGYLE CUSTOM TUBING PACK
K842889 · DWF
Sherwood Medical Co.
Cardiovascular · 35d
Cleared Aug 27, 1984
KEMBLE 405
K842894 · JQW
Kemble Instruments, Inc.
Chemistry · 35d
Cleared Aug 27, 1984
WBA - I.R.I.S.
K842895 · JAM
Siemens Gammasonics, Inc.
Radiology · 35d
Cleared Aug 27, 1984
LASER RECTOSCOPE SET 784
K842997 · FDC
Laser Industries , Ltd.
Gastroenterology & Urology · 28d
Cleared Aug 27, 1984
TOTAL PROTEIN ASSAY KIT
K843028 · CEK
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 26d
Cleared Aug 27, 1984
HIGH DENSITY LIPOPROTEIN PRECIPITATIN
K843029 · LBS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 26d
Cleared Aug 27, 1984
INORGANIC PHOSPHORUS ASSAY KIT
K843030 · CEO
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 26d
Cleared Aug 27, 1984
MAGNESIUM ASSAY KIT
K843031 · JGJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 26d
Cleared Aug 27, 1984
UREA ASSAY KIT
K843057 · CDQ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 24d
Cleared Aug 27, 1984
SYSTEMATE CREATININE 67223
K843105 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 20d
Cleared Aug 27, 1984
SYSTEMATE TRIGLYCERIDE 67219
K843106 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 20d
Cleared Aug 27, 1984
SYSTEMATE TOTAL PROTEIN 67218
K843107 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 20d
Cleared Aug 27, 1984
SYSTEMATE ALBUMIN
K843108 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 20d
Cleared Aug 27, 1984
KODAK T-MAT H FILM SO-118
K843148 · LWZ
Eastman Kodak Company
Cardiovascular · 17d
Cleared Aug 27, 1984
KODAK T-MAT C FILM SO-119
K843149 · LWZ
Eastman Kodak Company
Radiology · 17d
Cleared Aug 27, 1984
SYSTEMATE GLUCOSE 67216
K843150 · CFR
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Aug 27, 1984
SYSTEMATE GLUCOSE 67215
K843151 · CGA
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Aug 27, 1984
KODAK X-OMATIC RADIATION THERAPY CASS
K843176 · IXA
Eastman Kodak Company
Radiology · 14d