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
171817–171840 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 1978
BACILLUS PUMILUS
K780974 · FRL
Urol, Inc.
Radiology · 48d
Cleared Jul 27, 1978
PLATELET CONTROL
K780980 · JPK
Bhp Diagnostix, Inc.
Hematology · 45d
Cleared Jul 27, 1978
CALCIUM REAGENT SYSTEM NO. 585
K780983 · CIC
Sigma Chemical Co.
Chemistry · 43d
Cleared Jul 27, 1978
PVC LINES FOR MONITORING
K780985 · GAZ
Norton Performance Plastics Corp.
General Hospital · 43d
Cleared Jul 27, 1978
AMALGAM ALLOY
K780997 · EJJ
Syntex Corp.
Dental · 43d
Cleared Jul 27, 1978
SCALPEL
K780998 · GDX
Isolab, Inc.
General & Plastic Surgery · 43d
Cleared Jul 27, 1978
HMA URIC ACID TEST
K781004 · KNK
Hycel, Inc.
Chemistry · 41d
Cleared Jul 27, 1978
ANALYZER, SERUM IRON & TOTAL IRON BINDIN
K781009 · JMD
Environmental Sciences Assoc., Inc.
Chemistry · 38d
Cleared Jul 27, 1978
MERCURY/HYDRIDE ATOMIC ABSORPTION ACCESS
K781010 · DPH
The Perkin-Elmer Corp.
Toxicology · 41d
Cleared Jul 27, 1978
RIA TEST KIT SYS. DAMON KIQUISOL FREE
K781012 · CEC
Damon Corp.
Hematology · 41d
Cleared Jul 27, 1978
(AST) OR (ALT) UV DETERM. PHY. PHOS.
K781020 · CIT
The Dow Chemical Co.
Chemistry · 42d
Cleared Jul 27, 1978
LAMBDA SERUM (FREE) ANTI-HUMAN
K781025 · DEH
Icl Scientific
Immunology · 38d
Cleared Jul 27, 1978
KAPPA SERUM (FREE) ANTI-HUMAN
K781027 · DFH
Icl Scientific
Immunology · 38d
Cleared Jul 27, 1978
KAPPA SERUM (FREE & BOUND) ANTI-HUMAN
K781028 · DFH
Icl Scientific
Immunology · 38d
Cleared Jul 27, 1978
AEROPLAST DRESSING
K781031 · KMF
Parke-Davis Co.
General & Plastic Surgery · 38d
Cleared Jul 27, 1978
PROLITH 23S PACEMAKER
K781042 · DXY
Edwards Pacemaker Systems
Cardiovascular · 37d
Cleared Jul 27, 1978
A-33 DENTAL ALLOY
K781045 · EJT
Howmedica Corp.
Dental · 36d
Cleared Jul 27, 1978
LIFELINE AMBULATORY
K781054 · DPS
Imc
Cardiovascular · 36d
Cleared Jul 27, 1978
CONTROL, HEMATOLOGY, CH-60
K781077 · JPK
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 29d
Cleared Jul 27, 1978
MONITOR KITS, BLOOD LEVEL
K781145 · DTW
3M Health Care, Sarns
Cardiovascular · 17d
Cleared Jul 27, 1978
RIA TSH IN HUMAN SERUM OR PLASMA
K781150 · JLW
Diagnostic Corp. of America
Immunology · 17d
Cleared Jul 27, 1978
CHOLESTEROL & HDL CHOL. PROCEDURE
K781165
Data Medical Associates, Inc.
Chemistry · 15d
Cleared Jul 27, 1978
WRENCH, GEXAGON, DRIVER
K781179 · DTF
Telectronics, Inc.
Cardiovascular · 13d
Cleared Jul 27, 1978
COMPRESSOR, AIR, MINI-SILENT
K781213 · BTI
The John Bunn Co.
Anesthesiology · 17d