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

Filters: Cleared only ×
176,076 results
160561–160584 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 1982
AS 700 SERIES INFUSION PUMP ADMIN.
K821377 · FPA
Narco Scientific
General Hospital · 53d
Cleared Jul 02, 1982
SERO/TEX MONO TEST
K821386 · KTN
Texas Immunology, Inc.
Immunology · 53d
Cleared Jul 02, 1982
SERO/TEX CRP TEST
K821388 · DCN
Texas Immunology, Inc.
Immunology · 53d
Cleared Jul 02, 1982
DISPOSABLE BLOOD PRESSURE TRANSDUCER
K821416 · DRS
Bentley Laboratories, Inc.
Cardiovascular · 51d
Cleared Jul 02, 1982
MICRO-SURGICAL POWER INSTRUMENT SYS.
K821487 · GFA
Spire Medical, Inc.
General & Plastic Surgery · 45d
Cleared Jul 02, 1982
MEDICOTEST ELECTRODE PASTE
K821539 · GYB
Medicotest, Inc.
Neurology · 39d
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