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
175033–175056 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 29, 1976
TRIGLYCERIDES (LIPASE) REAGENT SET
K761262 · CDT
Worthington Biochemical Corp.
Chemistry · 13d
Cleared Dec 29, 1976
CHOLESTEROL AUTOMATED REAGENT
K761263 · CHH
Worthington Biochemical Corp.
Chemistry · 13d
Cleared Dec 29, 1976
GEMENI GPT (ALT) ASSAY
K761269 · CKA
Electro-Nucleonics Laboratories, Inc.
Chemistry · 13d
Cleared Dec 29, 1976
PET-SCOPE
K761285 · JAA
Diagnostic Information, Inc.
Radiology · 9d
Cleared Dec 28, 1976
ELECTROSURGICAL DISPERSIVE PLATE
K760675 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 102d
Cleared Dec 28, 1976
POCKET TRANSMITTER (PT-10)
K761073 · DXH
Eldeco
Cardiovascular · 39d
Cleared Dec 28, 1976
DYNAMIC RECORDER (DR-10)
K761074 · DSH
Eldeco
Cardiovascular · 39d
Cleared Dec 28, 1976
SPORTS RECORDER (SR-10)
K761075
Eldeco
Physical Medicine · 39d
Cleared Dec 28, 1976
DEMODULATOR/CARDIOTACHOMETER
K761076 · DRT
Eldeco
Cardiovascular · 39d
Cleared Dec 28, 1976
TREND ANALYZER
K761077 · DSF
Eldeco
Cardiovascular · 39d
Cleared Dec 28, 1976
P-1 ULTRASONIC ARTERIOGRAPH
K761288 · DPW
D. Eugene Hokanson
Cardiovascular · 8d
Cleared Dec 28, 1976
CENTRAL STATION MONITORING SYSTEM
K761291 · DRT
Abbott Laboratories
Cardiovascular · 7d
Cleared Dec 23, 1976
ARNCO I.V. MONITOR
K760694 · FLN
A.R. Nelson Co., Inc.
General Hospital · 92d
Cleared Dec 23, 1976
LITHIUM IODIDE BATTERY PACEMAKER (#201)
K761143 · DXY
Pacesetter Systems
Cardiovascular · 27d
Cleared Dec 23, 1976
SERIES 700 PATIENT MONITORS
K761244 · FLL
Spacelabs, Inc.
General Hospital · 10d
Cleared Dec 23, 1976
DOVER LOW PRESSURE TRACHEAL TUBE
K761258 · BTO
Will Ross Co.
Anesthesiology · 8d
Cleared Dec 23, 1976
OPTIONS FOR STAR DENTAL OPUS I
K761264 · DYN
Syntex Corp.
Dental · 7d
Cleared Dec 23, 1976
AIROTOS LF HANDPIECE
K761275 · DZA
Dentsply Intl.
Dental · 3d
Cleared Dec 23, 1976
DENTAL STOOL
K761276
Dentsply Intl.
Dental · 3d
Cleared Dec 22, 1976
TOBRAMYCIN RIA KIT
K760967 · KLB
Diagnostic Products Corp.
Immunology · 48d
Cleared Dec 21, 1976
BARRIER NEURO SHEET
K760937 · KKX
Surgikos, Inc.
General Hospital · 50d
Cleared Dec 21, 1976
B12/FOLATE SING. TUBE DUAL RADIOASSAY KT
K760946 · CDD
Schwarz Mann
Chemistry · 50d
Cleared Dec 21, 1976
SURGICAL BLADE HANDLES
K761035 · GDZ
Parke-Davis Co.
General & Plastic Surgery · 36d
Cleared Dec 21, 1976
CHOLESTEROL CALIBRATOR
K761197 · JIT
Beckman Instruments, Inc.
Chemistry · 15d