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
159865–159888 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 1982
CALCIUM STANDARD, ITEM #65075
K822473 · JIS
Emd Chemicals, Inc.
Chemistry · 31d
Cleared Sep 17, 1982
CREATININE STANDARD #65072
K822477 · JIS
Emd Chemicals, Inc.
Chemistry · 31d
Cleared Sep 17, 1982
MULTIPLE SURGICAL MASK
K822481 · FXX
Surgilite Intl., Inc.
General Hospital · 31d
Cleared Sep 17, 1982
MULTIPLE SCRUB SUIT
K822483 · FXO
Surgilite Intl., Inc.
General Hospital · 31d
Cleared Sep 17, 1982
DISPOSABLE GRASPING FORCEPS
K822491 · GEN
Van-Tec, Inc.
General & Plastic Surgery · 30d
Cleared Sep 17, 1982
OPTIMIZED UV-LDH REAGENT SET
K822492 · CFJ
Biorent Diagnostic, Inc.
Chemistry · 30d
Cleared Sep 17, 1982
CDL LYSING REAGENT
K822500 · GGK
Connecticut Diagnostics, Ltd.
Hematology · 30d
Cleared Sep 17, 1982
CDL ISOTONIC DILUENT
K822501 · GIF
Connecticut Diagnostics, Ltd.
Hematology · 30d
Cleared Sep 17, 1982
CDL AUTO-LYSING REAGENT
K822504 · GGK
Connecticut Diagnostics, Ltd.
Hematology · 29d
Cleared Sep 17, 1982
SYRINGES(2-PARTS SINGLE USE)
K822532 · FMF
Impex Laboratories
General Hospital · 24d
Cleared Sep 17, 1982
SYRINGES(3-PARTS SINGLE USE)
K822533 · FMF
Impex Laboratories
General Hospital · 24d
Cleared Sep 17, 1982
NEEDLES(HYPODERMIC)
K822534 · FMF
Impex Laboratories
General Hospital · 24d
Cleared Sep 17, 1982
PRESSURE-QUET TOURNIQUET
K822553 · GAX
Nutec Med, Inc.
Hematology · 24d
Cleared Sep 17, 1982
ADVANCE EMIT-CAD QUINIDINE ASSAY
K822588 · LBZ
Syva Co.
Toxicology · 22d
Cleared Sep 17, 1982
HEMACOUNT WRIGHT GIEMSA STAIN PACK
K822602 · JAF
Accra Laboratories, Inc.
Pathology · 21d
Cleared Sep 17, 1982
ANTINUCLEAR ANTOBODY CELL SUBSTRATE
K822607 · DHN
Immulok, Inc.
Immunology · 21d
Cleared Sep 17, 1982
TOTAL FINGER FLEXION SPLINT
K822651 · ILH
Alimed, Inc.
Physical Medicine · 15d
Cleared Sep 15, 1982
BI-4520 DUAL IMPEDOMETER
K821723
Farrall Instruments, Inc.
General & Plastic Surgery · 98d
Cleared Sep 15, 1982
ATC BIOELECTROGRAPHIC MONITOR MODEL I.
K822626
Advantage Medical Systems, Inc.
Obstetrics & Gynecology · 13d
Cleared Sep 14, 1982
NEW SUPPORT SYS. FOR BEDRIDDEN PATIENTS
K821185 · FNL
Dase Co.
General Hospital · 140d
Cleared Sep 14, 1982
MICROKNIFE
K821769 · EMF
Biological & Environmental Control...
General & Plastic Surgery · 96d
Cleared Sep 14, 1982
ACTISORB* ACTIVATED CHARCOAL CLOTH DRSG.
K821797
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 88d
Cleared Sep 14, 1982
QBC CENTRIFUGAL HEMATOLOGY SYSTEM
K821803 · GKG
Bd Becton Dickinson Vacutainer...
Hematology · 90d
Cleared Sep 14, 1982
RUBELLA RQ BIO-ENZABEAD KIT
K821804 · LFX
Litton Bionetics
Microbiology · 89d