FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
159025–159048 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 14, 1982
OXY-PMMA
K821866 · HPX
Petrarch Systems & Professional Pharm
Ophthalmic · 82d
Cleared Sep 14, 1982
ZIMMER METAL BACKED ACETABULAR CUP
K821893 · JDI
Zimmer, Inc.
Orthopedic · 78d
Cleared Sep 14, 1982
NAGASHIMA SN-SP UNIT AND CHAIR
K822016 · ETF
Kelleher Corp.
Ear, Nose, Throat · 68d
Cleared Sep 14, 1982
DIAGLAZE
K822142 · EJR
Antraco, Inc.
Dental · 56d
Cleared Sep 14, 1982
RE1000 HEART RATE MONITOR
K822319 · DRT
Electronic Monitors, Inc.
Cardiovascular · 42d
Cleared Sep 14, 1982
POWDER BLOWERS
K822351 · KMA
Kelleher Corp.
Ear, Nose, Throat · 39d