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
152065–152088 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 1984
SYSTEMATE LDH, 67210
K843269 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 13, 1984
SYSTEMATE ALKALINE PHOSPHATASE-67203
K843270 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 13, 1984
ELVI 675 DIGITRON
K843296 · JJQ
Logos Scientific, Inc.
Chemistry · 23d
Cleared Sep 13, 1984
SYSTEMATE URIC ACID, HEM 67220
K843325 · KNK
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Sep 13, 1984
CENTURIAN HYDRAULIC STRETCHER
K843439 · FPO
American Sterilizer Co.
General Hospital · 9d
Cleared Sep 12, 1984
CAPILLARY FLOW DIALYZERS
K840937 · KOC
Travenol Laboratories, S.A.
Gastroenterology & Urology · 191d
Cleared Sep 12, 1984
HASTINGS BIPOLAR ENDOPROSTHESIS
K842344 · KWY
Johnson & Johnson Professionals, Inc.
Orthopedic · 90d
Cleared Sep 12, 1984
PM 2000 DENTAL UNIT
K842357 · EIA
Planmeca USA, Inc.
Dental · 82d
Cleared Sep 12, 1984
OXALATE URINE CONTROLS NORMAL & ELEVAT
K842366 · JJW
Sigma Chemical Co.
Chemistry · 89d
Cleared Sep 12, 1984
HEMOPERFUSION PROCEDURE W/REDY 2000
K842513 · FKT
Organon Teknika Corp.
Gastroenterology & Urology · 78d
Cleared Sep 12, 1984
SUCROSEP THYROID STIMULATING HORMONE
K842593 · JLW
Boots-Celltech Diagnostics, Inc.
Chemistry · 71d
Cleared Sep 12, 1984
BRITISH SPINAL FUSION SET
K842698 · FZX
Downs Surgical , Ltd.
General & Plastic Surgery · 63d
Cleared Sep 12, 1984
BASILDON-GARDNER SPINAL FRAME
K842700 · FWZ
Downs Surgical , Ltd.
General & Plastic Surgery · 63d
Cleared Sep 12, 1984
RADIOMETRIC BLOOD CULTURE VIALS, AEROBE
K842874 · JTA
American Micro Scan
Microbiology · 51d
Cleared Sep 12, 1984
DECOLORIZING FLUIC, ACID-ALCOHOL 3%
K842934 · PPM
E K Ind., Inc.
Pathology · 49d
Cleared Sep 12, 1984
ACETIC ACID, 5% V/V
K842935 · GGK
E K Ind., Inc.
Hematology · 49d
Cleared Sep 12, 1984
ACETIC ACID, 3% V/V
K842936 · GGK
E K Ind., Inc.
Hematology · 49d
Cleared Sep 12, 1984
ACETIC ACID 2% V/V
K842937 · GGK
E K Ind., Inc.
Hematology · 49d
Cleared Sep 12, 1984
APPLELISA CHLAMYDIA TRACHOMATIS ANTI
K843120 · LJC
Apple Diagnostic Products
Microbiology · 35d
Cleared Sep 12, 1984
RADIONICS MINI & STANDARD SHUNT VALVE
K843132 · JXG
Radionics, Inc.
Neurology · 34d
Cleared Sep 12, 1984
EMIT 700 CALIBRATOR A
K843163 · DKB
Syva Co.
Toxicology · 33d
Cleared Sep 12, 1984
AMIKACIN ANALYTICAL TEST PACK ACA
K843211 · KLQ
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 28d
Cleared Sep 12, 1984
STRATUS QUINIDINE FLUOROMETRIC ENZYME
K843237 · LBZ
American Dade
Toxicology · 21d
Cleared Sep 12, 1984
KAPP SPINAL BUTTON
K843368 · HTN
Kapp Surgical Instrument, Inc.
Orthopedic · 15d