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
159721–159744 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 1982
LEVEL II CONTROL SERUM
K821558 · JJX
Irvine Scientific
Chemistry · 38d
Cleared Jul 02, 1982
BOUNDARY PROCESS CHANGE
K821564 · FYA
The Buckeye Cellulose Corp.
General Hospital · 38d
Cleared Jul 02, 1982
SYSMEX CC-800
K821575 · GKL
Sysmex/Toa Medical Electronics, Inc.
Hematology · 36d
Cleared Jul 02, 1982
LEONARD/NORTON HYPERALIMENTATION CATHET.
K821679 · FOZ
Norton Performance Plastics Corp.
General Hospital · 24d
Cleared Jul 02, 1982
J & J DIP WATER ADDITIVE
K821693 · FYH
Johnson & Johnson Professionals, Inc.
General Hospital · 24d
Cleared Jul 02, 1982
DISP. MICROSURGICAL KNIVES
K821737 · GES
Coburn Optical Ind., Inc.
General & Plastic Surgery · 18d
Cleared Jul 02, 1982
URICACID
K821741 · KNK
Biodynamics Corp.
Chemistry · 18d
Cleared Jul 02, 1982
POSITIVE & NEGATIVE HCG URINE CONTROLS
K821742 · JJX
Armkel, LLC
Chemistry · 18d
Cleared Jul 02, 1982
EMIT-TOX SERUM TRICYCLIC ANTIDEPR. ASSAY
K821743 · LFG
Syva Co.
Toxicology · 18d
Cleared Jul 02, 1982
DESERET E-Z SET INFUSION SET
K821750 · FPA
Warner-Lambert Co.
General Hospital · 17d
Cleared Jul 02, 1982
TELCOR 2
K821755 · DRT
Burdick Corp.
Cardiovascular · 17d
Cleared Jul 02, 1982
QUIK - PREP2 ELECTRODE
K821757 · DRX
Quinton, Inc.
Cardiovascular · 17d
Cleared Jul 02, 1982
TERGITOL 7 AGAR WITH TTC
K821775 · JSI
Granite Diagnostics, Inc.
Microbiology · 15d
Cleared Jul 02, 1982
BEACH FORCEP NO. 150 AND NO. 151
K821781 · EMG
Pacific Dental Corp.
Dental · 15d
Cleared Jul 02, 1982
NOVA V FLUIDS PACK & EXTERNAL STANDARDS
K821794 · JIX
Shaban Mfg. Co.
Chemistry · 14d
Cleared Jul 02, 1982
PYRIDOXAL-5-PHOSPHATE STRIPES
K821805 · CKA
Boehringer Mannheim Corp.
Chemistry · 15d
Cleared Jul 02, 1982
AMERIFLOUR FLUOROMETER
K821807 · JQP
American Diagnostic Corp.
Chemistry · 15d
Cleared Jul 02, 1982
125I DIGOXIN RADIOIMMUNOASSAY KIT
K821811 · DPB
Cambridge Medical Technology
Chemistry · 14d
Cleared Jul 02, 1982
BECKMAN URIC ACID REAGENT
K821812 · KNK
Beckman Instruments, Inc.
Chemistry · 14d
Cleared Jul 02, 1982
BECKMAN URIC ACID STANDARD
K821813 · JIS
Beckman Instruments, Inc.
Chemistry · 14d
Cleared Jul 02, 1982
MODEL 1020 NA/K ANALYZER
K821822 · CEM
Thermo Orion
Chemistry · 10d
Cleared Jul 02, 1982
MODEL 100 BICARBONATE CONDUCTIVITY
K821834 · FKQ
Western Laboratories Corp.
Gastroenterology & Urology · 10d
Cleared Jul 02, 1982
BARRIER BURN SHEET
K821835 · KME
Uhi Corp.
General Hospital · 10d
Cleared Jul 02, 1982
MEDIGAS SUCTION/DRAINAGE EQUIPMENT
K821841 · GCX
Linde Div. Union Carbide Corp.
General Hospital · 10d