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
144385–144408 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 1986
BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES)
K860720 · JJQ
Biotrack, Inc.
Hematology · 86d
Cleared May 23, 1986
BIOTRACK PROTIME TEST PROTHROMBIN TIME TEST
K860721 · GJS
Biotrack, Inc.
Hematology · 86d
Cleared May 23, 1986
TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560
K860773 · LGD
Clinical Sciences, Inc.
Microbiology · 81d
Cleared May 23, 1986
EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95
K860935 · CIJ
Em Diagnostic Systems, Inc.
Chemistry · 72d
Cleared May 23, 1986
QUANTIMETRIX HUMAN BILIRUBIN CONTROL I & II LIQUID
K860942 · JJY
Quantimetrix Corp.
Chemistry · 72d
Cleared May 23, 1986
INTERPORE 200 POROUS HYDROXYAPATITE
K860983 · LYC
Interpore Intl.
Dental · 67d
Cleared May 23, 1986
THERACHEM-PLUS, TRI-LEVEL TDC (TM)
K861185 · JJY
Fisher Scientific Co., LLC
Toxicology · 53d
Cleared May 23, 1986
MESULIN, INSULIN INFUSION SET
K861250 · FPA
Molnlycke A/S Hospital Products
General Hospital · 51d
Cleared May 23, 1986
MMS T3 UPTAKE
K861262 · KHQ
Micromedic Systems
Chemistry · 49d
Cleared May 23, 1986
DIRECT READOUT MODULE ACCESSORY
K861412 · JQP
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 38d
Cleared May 23, 1986
ALBUMIN (BCG) REAGENT
K861467 · CIX
Sigma Diagnostics, Inc.
Chemistry · 32d
Cleared May 23, 1986
EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95
K861512 · JJT
Em Diagnostic Systems, Inc.
Chemistry · 30d
Cleared May 23, 1986
DISPOSABLE SURGICAL DRAPES AND ACCESSORIES
K861531 · KKX
Medical Concepts Development, Inc.
General Hospital · 29d
Cleared May 23, 1986
CONTROL SERA LEVEL VALUES (MG/DL)
K861567 · JJY
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 25d
Cleared May 23, 1986
WECK-KREEM, CATALOG NO. 850-155
K861589
Palmetto Chemical & Supply Co., Inc.
General & Plastic Surgery · 24d
Cleared May 23, 1986
WECK-LUBE, CATALOG NO. 850-150
K861591
Palmetto Chemical & Supply Co., Inc.
General & Plastic Surgery · 24d
Cleared May 23, 1986
TOTAL IRON BINDING CAPACITY PROCEDURE
K861602 · CFM
Data Medical Associates, Inc.
Chemistry · 24d
Cleared May 23, 1986
IRON PROCEDURE
K861603 · JJY
Data Medical Associates, Inc.
Chemistry · 24d
Cleared May 23, 1986
SALICYLATE REAGENT SET
K861615 · DKJ
Sterling Diagnostics, Inc.
Toxicology · 24d
Cleared May 23, 1986
LIQUID CHROMATOGRAPHY COLUMNS
K861633 · DPM
Supelco, Inc.
Toxicology · 24d
Cleared May 23, 1986
MODUMATIC (R) DILUTER
K861640 · JQW
Tri-Continent Scientific, Inc.
Chemistry · 23d
Cleared May 23, 1986
GLUCOSE HK PROCEDURE
K861653 · CGA
Data Medical Associates, Inc.
Chemistry · 23d
Cleared May 23, 1986
SERUM POTASSIUM REAGENT SET
K861713 · CEJ
Sterling Diagnostics, Inc.
Chemistry · 18d
Cleared May 23, 1986
3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE
K861749 · FSP
Keeler Instruments, Inc.
General & Plastic Surgery · 17d