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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
143425–143448 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1986
OSTEOTOMY DRAINAGE TUBE
K862584 · GBS
Treace Medical, Inc.
General & Plastic Surgery · 36d
Cleared Aug 12, 1986
MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT
K862832 · CIT
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 18d
Cleared Aug 12, 1986
ALMORE FACE MASK
K862851
Almore Intl., Inc.
General & Plastic Surgery · 14d
Cleared Aug 12, 1986
RENAMELIZE POLISHING PASTE
K862912 · EJR
Cosmedent, Inc.
Dental · 11d
Cleared Aug 12, 1986
KODAK CFT FILM SO-141
K862944 · IWZ
Eastman Kodak Company
Radiology · 7d
Cleared Aug 11, 1986
MODEL 9000 RECORDING & ELECTROPHYSIOLOGICAL SYSTEM
K860456 · GWQ
Oxford Medilog, Inc.
Neurology · 187d
Cleared Aug 11, 1986
ULTRASONIC IMAGING SYSTEM (MODIFIED)
K860568 · ITX
Interspec, Inc.
Radiology · 178d
Cleared Aug 11, 1986
INTRAMEDULLARY ROD
K861183
The Deca Co.
Orthopedic · 133d
Cleared Aug 11, 1986
MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE
K861845 · HHR
Directed Energy, Inc.
Obstetrics & Gynecology · 90d
Cleared Aug 11, 1986
DIETO CONTAINER FOR ENTERAL NUTRITION
K861862 · KNT
Gil-Med Industries C/O Kegan & Kegan,...
Gastroenterology & Urology · 90d
Cleared Aug 11, 1986
MODIFIED PROTECTIVE GARMENT
K861863 · EYQ
Procter & Gamble Mfg. Co.
Gastroenterology & Urology · 88d
Cleared Aug 11, 1986
RAPID ENDOSCOPIC LAVAGE SYSTEM
K862058 · OCX
Endovations
Gastroenterology & Urology · 73d
Cleared Aug 11, 1986
ARTHROSCOPE
K862275 · HRX
Comeg USA, Inc.
Orthopedic · 56d
Cleared Aug 11, 1986
SCHNEIDER-SHILEY OCCLUDER/FLUSHING CATH. STOPCOCK
K862465 · DQO
Shiley, Inc.
Cardiovascular · 42d
Cleared Aug 11, 1986
SCHNEIDER-SHILEY SELDINGER INITIAL PUNCTURE INSTR
K862467 · LIT
Shiley, Inc.
Cardiovascular · 42d
Cleared Aug 11, 1986
BAUSCH & LOMB CONTACT LENS VIEWER
K862517 · HLF
Bausch & Lomb, Inc.
Ophthalmic · 41d
Cleared Aug 11, 1986
BAUSCH & LOMB VERTOMETER V-5
K862518 · HLM
Bausch & Lomb, Inc.
Ophthalmic · 41d
Cleared Aug 11, 1986
DEKNATEL (R) TREPHINE
K862524 · HRH
Deknatel, Inc.
Ophthalmic · 40d
Cleared Aug 11, 1986
TUBING CONNECTOR #10-810-60 100/PKG NON-STERILE
K862722 · FKY
Mercury Enterprises, Inc.
Gastroenterology & Urology · 25d
Cleared Aug 11, 1986
MODEL A-8000 ULTRASONIC HANDPIECE CORD
K862777 · HQC
Advanced Medical Technology, Inc.
Ophthalmic · 20d
Cleared Aug 11, 1986
SPUNGUARD HOSPITAL COVERALL
K862804
Kimberly-Clark Corp.
General & Plastic Surgery · 20d
Cleared Aug 11, 1986
MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR
K862852 · GFF
Micro-Aire Surgical Instruments, Inc.
General & Plastic Surgery · 13d
Cleared Aug 08, 1986
NEOS VS-1, PULSE GENERATOR
K860921 · DXY
Biotronik Sales, Inc.
Cardiovascular · 150d
Cleared Aug 08, 1986
LA DIFFUSION TECHNIQUE, KTY CM-10 BREAST PUMP
K861513 · HGX
Crystal Medical Products, Inc.
Obstetrics & Gynecology · 107d