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
167137–167160 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 1980
LINEBERGER EXTERNAL MALE CATHETER
K800890 · KNX
Lineberger External Catheter Co.
Gastroenterology & Urology · 63d
Cleared Jun 20, 1980
A-GENT THYROZYME UPTAKE INHIBITOR ASSAY
K800911 · KHQ
Abbott Laboratories
Chemistry · 60d
Cleared Jun 20, 1980
URINARY CATHETER SAMPLING KIT
K800946 · KDT
Sage Products, Inc.
Pathology · 59d
Cleared Jun 20, 1980
STANBIO ACETAMINOPHEN TEST SET #0850
K801014 · LDP
Stanbio Laboratory
Toxicology · 53d
Cleared Jun 20, 1980
E-VAX CHEST DRAINAGE SYSTEM
K801043 · JCX
Cardio Surgical Concepts, Inc.
General & Plastic Surgery · 46d
Cleared Jun 20, 1980
COBAS REAGENT FOR AST (SGOT)
K801118 · CIT
Roche Analytical Instruments, Inc.
Chemistry · 39d
Cleared Jun 20, 1980
D300 DOME
K801136 · DRS
Gics Pharmaceuticals
Cardiovascular · 39d
Cleared Jun 20, 1980
PROXIMATE*(ILS) DISP. INTRALUMINAL STAP.
K801154 · GDW
Ethicon, Inc.
General & Plastic Surgery · 37d
Cleared Jun 20, 1980
STREPTO-SEC TM
K801159 · GTZ
Organon, Inc.
Microbiology · 40d
Cleared Jun 20, 1980
DIGOXIN RADIOIMMUNOASSAY KIT
K801202 · LCS
Technia Diagnostics , Ltd.
Toxicology · 32d
Cleared Jun 20, 1980
EMIT VALPROIC ACID ASSAY
K801207 · LEG
Syva Co.
Toxicology · 32d
Cleared Jun 20, 1980
TRIGLYCERIDES FOR SMA AND AAII
K801226 · CDT
Reagents Applications, Inc.
Chemistry · 29d
Cleared Jun 20, 1980
REIGNING ARTIFICIAL TEETH/POLYCARB.RESIN
K801235 · ELM
Oki Shiks USA , Ltd.
Dental · 24d
Cleared Jun 20, 1980
COBAS REAGENT FOR ALKALINE PHOSPHATASE
K801242 · CJE
Roche Analytical Instruments, Inc.
Chemistry · 24d
Cleared Jun 20, 1980
ROCHE HCG STANDARDS
K801244 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 24d
Cleared Jun 20, 1980
ATOMLIGHT (LIQUID SCINTILLATION SOLUTION
K801245 · JJJ
New England Nuclear
Toxicology · 24d
Cleared Jun 20, 1980
NUCLEAR ENTERPRISES 1612 MULTI-WELL
K801263 · JJJ
Nuclear Ent. , Ltd.
Toxicology · 23d
Cleared Jun 20, 1980
DUPONT PREP APPLI. FOR PHENOBARBITAL,
K801276 · DKH
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 23d
Cleared Jun 20, 1980
J.T. BAKER IMMUNOGLOBULIN G NEPHELOMETRI
K801281 · DEW
J.T. Baker Chemical Co.
Immunology · 22d
Cleared Jun 20, 1980
SURGICAL INSTRUMENTS
K801292
William Skidmore & Co., Ltd.
General & Plastic Surgery · 18d
Cleared Jun 20, 1980
GOLDEN THERMAL RHINOPLASTY CAST BANDAGE
K801301 · ILO
Auric, Inc.
Physical Medicine · 17d
Cleared Jun 20, 1980
FIAX TEST KIT FOR TOBRAMYCIN QUANTITA
K801308 · LCR
Intl. Diagnostic Technology
Toxicology · 17d
Cleared Jun 20, 1980
RITTER STERILIZER
K801309 · FLE
Sybron Corp.
General Hospital · 17d
Cleared Jun 20, 1980
THE MAGTEC SYSTEM
K801310
Valley Forge Scientific Corp.
General & Plastic Surgery · 17d