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
142825–142848 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1986
REGULAR PETAL SOFT PLASTIC APPLI. TAMPAX TAMPONS
K861909 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 85d
Cleared Aug 12, 1986
SUPER PETAL SOFT PLASTIC APPLICATOR TAMPAX TAMPONS
K861910 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 85d
Cleared Aug 12, 1986
SUPER PLUS PETAL SOFT PLASTIC APPLI. TAMPAX TAMPON
K861911 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 85d
Cleared Aug 12, 1986
SUPER PLUS TAMPAX TAMPONS
K861912 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 85d
Cleared Aug 12, 1986
SLENDER REGULAR TAMPAX TAMPONS
K861913 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 85d
Cleared Aug 12, 1986
CAMINO CSF DRAINAGE SYSTEM MODEL 040
K861961 · JXG
Camino Laboratories, Inc.
Neurology · 84d
Cleared Aug 12, 1986
KEYMED FLEXIBLE ESOPHAGEAL DILATORS
K862000 · KNQ
Keymed, Inc.
Gastroenterology & Urology · 81d
Cleared Aug 12, 1986
BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH.
K862303 · JXG
Pudenz-Schulte Medical Research Corp.
Neurology · 56d
Cleared Aug 12, 1986
CABOT MEDICAL VARIABLE FLOW INSUFFLATOR
K862310 · HES
Cabot Medical Corp.
Obstetrics & Gynecology · 56d
Cleared Aug 12, 1986
ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION
K862456 · HHR
Cooper Lasersonics, Inc.
Obstetrics & Gynecology · 46d
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