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
155545–155568 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 1983
EXTERNAL PULSE GENERATOR FOR TEMP. STIM
K831768 · DTE
Oscor, Inc.
Cardiovascular · 198d
Cleared Dec 16, 1983
BATTERY-OPERATED ELECTROCARDIOGRAPH
K832421 · DPS
Somatronix Research Corp.
Cardiovascular · 147d
Cleared Dec 16, 1983
MAGNATRODE CARDIAC MONITORING ELECTRODE
K832516 · DRX
R2 Corp.
Cardiovascular · 141d
Cleared Dec 16, 1983
CENTRALERT
K833147 · BSZ
Draeger Medical, Inc.
Anesthesiology · 92d
Cleared Dec 16, 1983
TUBING CONNECTORS EC-2XXX SERIES
K833322 · DTL
Gish Biomedical, Inc.
Cardiovascular · 81d
Cleared Dec 16, 1983
RESPIRONICS RESCUE DOME
K833328 · CAE
Respironics, Inc.
Anesthesiology · 80d
Cleared Dec 16, 1983
N-ACETYLPROCAINAMIDE CALIBRATOR
K833385 · DLG
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 78d
Cleared Dec 16, 1983
HUMPHREY A.D.E. SYSTEM
K833478 · CAI
Anaesthetic Breathing System
Anesthesiology · 53d
Cleared Dec 16, 1983
WILLIAM HARVEY H-71-5-F CARDIOTOMY
K833479 · DTN
C.R. Bard, Inc.
Cardiovascular · 70d
Cleared Dec 16, 1983
OXYGEN MONITOR/CONTROLLER
K833496 · CCL
Oxequip Health Ind.
Anesthesiology · 70d
Cleared Dec 16, 1983
PACEMAKER SYS ANALYZER #384
K833647 · KRE
Pacesetter Systems
Cardiovascular · 60d
Cleared Dec 16, 1983
CD-102 CARBON DIOXIDE ANALYZER/RECOR
K833739 · CCJ
Instrumentarium Corp.
Anesthesiology · 52d
Cleared Dec 16, 1983
GROUP STREP BROTH T3472 LIM
K833759 · JSD
Gibco Laboratories Life Technologies,...
Microbiology · 51d
Cleared Dec 16, 1983
CLOSTRIDIUM DIFFICILE EY AGAR P2787
K833760 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 51d
Cleared Dec 16, 1983
TROJAN PLUS II
K833765 · HIS
Youngs Rubber Corp.
Obstetrics & Gynecology · 50d
Cleared Dec 16, 1983
PROCESS 100 ST
K833846 · IZO
Cgr Medical Corp.
Radiology · 92d
Cleared Dec 16, 1983
8 FRENCH DILATOR 15CM, W/LUER LOCK
K833965 · DRE
Quinton, Inc.
Cardiovascular · 30d
Cleared Dec 16, 1983
AQUAPAK 020 HUMIDIFIER ADAPTER
K833974 · BTT
Respiratory Care, Inc.
Anesthesiology · 30d
Cleared Dec 16, 1983
FACTOR II DEFICIENT SUBSTRATE PLASMA
K834031 · GGP
Helena Laboratories
Hematology · 24d
Cleared Dec 16, 1983
DRAGER PEEP SYSTEM D
K834085 · BYE
Draeger Medical, Inc.
Anesthesiology · 17d
Cleared Dec 16, 1983
IMPLANTABLE PULSE GENERATOR
K834096 · DXY
Intermedics, Inc.
Cardiovascular · 18d
Cleared Dec 15, 1983
GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLING
K834088 · HEM
Whs Products, Inc.
Obstetrics & Gynecology · 92d
Cleared Dec 14, 1983
STERILE DISP. INSTRUMENT TRAYS
K831841 · KDD
E.M. Adams
General & Plastic Surgery · 190d
Cleared Dec 14, 1983
ERIKA DI-ALA-KIT-SINGLE DIALYSIS ON/OF
K833252 · KOC
Erika, Inc.
Gastroenterology & Urology · 85d