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
174193–174216 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 21, 1976
ENZYMATIC TRIGLYCERIDES (END POINT)
K761200 · CDT
Beckman Instruments, Inc.
Chemistry · 15d
Cleared Dec 21, 1976
LIMB LEAD SEL. (ECG LEAD SWITCHING AD.)
K761210 · DRW
Physio-Control Corp.
Cardiovascular · 14d
Cleared Dec 21, 1976
CPK1SOENZYMES DETERMINATION PRO. #715-EP
K761212 · JHY
Sigma Chemical Co.
Chemistry · 14d
Cleared Dec 21, 1976
AUTO TOTAL PROTEIN
K761217 · CEK
Harleco
Chemistry · 14d
Cleared Dec 21, 1976
AUTO TOTAL BILIRUBIN REAGENT
K761218 · CIG
Harleco
Chemistry · 14d
Cleared Dec 21, 1976
QUICK CULT SLIDE TEST FECAL OCCULT BLOOD
K761232 · KHE
Laboratory Diagnostics Co., Inc.
Hematology · 11d