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
169081–169104 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 1979
ACCU-SORB STERILE STOCKINETTES
K791070 · KKX
Medline Industries, Inc.
General Hospital · 8d
Cleared Jun 20, 1979
WRENCH
K791073 · HXC
Truth, Inc.
Orthopedic · 8d
Cleared Jun 20, 1979
MODELS 2411/2418 VENTRICULAR-INHIBITED
K791093 · DXY
Medtronic Vascular
Cardiovascular · 8d
Cleared Jun 15, 1979
WHOLEY OCCLUSION BALLOON CATHETER
K772011 · FOZ
Cook, Inc.
General Hospital · 598d
Cleared Jun 15, 1979
EMIT-D.A.U. PHENCYCLIDINE URINE LOW
K790398 · DLJ
Syva Co.
Toxicology · 109d
Cleared Jun 15, 1979
URINE MEDIUM CALIBRATOR
K790399 · DLJ
Syva Co.
Toxicology · 109d
Cleared Jun 15, 1979
URINE NEGATIVE CALIBRATOR
K790400 · DLT
Syva Co.
Toxicology · 109d
Cleared Jun 15, 1979
PHENCYCLIDINE URINE ASSAY
K790401 · LCM
Syva Co.
Toxicology · 109d
Cleared Jun 15, 1979
CHOLESTEROL KIT, HDL-DS
K790553 · LBS
Beckman Instruments, Inc.
Chemistry · 88d
Cleared Jun 15, 1979
AMES TDA/GENTGMICIN
K790584 · DJB
Miles Laboratories, Inc.
Toxicology · 80d
Cleared Jun 15, 1979
IMPRESSION MATERIAL, RUBBER
K790592 · ELW
Wallace A. Erickson & Co.
Dental · 81d
Cleared Jun 15, 1979
DENTAL CEMENT, ZINC PHOSPHATE
K790593 · EMA
Wallace A. Erickson & Co.
Dental · 81d
Cleared Jun 15, 1979
DENTAL COMPOSITE RESTORATIVE MATERIAL
K790594 · EBF
Wallace A. Erickson & Co.
Dental · 81d
Cleared Jun 15, 1979
DENTAL ALGINATE IMPRESSION MATERIAL
K790595 · ELW
Wallace A. Erickson & Co.
Dental · 81d
Cleared Jun 15, 1979
ENAMEL BOND SYSTEM
K790596 · EBC
Wallace A. Erickson & Co.
Dental · 81d
Cleared Jun 15, 1979
BL BILIRUBINOMETER
K790608 · CIG
Advanced Instruments, Inc.
Chemistry · 78d
Cleared Jun 15, 1979
OSMOMETER MODEL 3W11
K790611 · JJM
Advanced Instruments, Inc.
Chemistry · 78d
Cleared Jun 15, 1979
NOVA 3 CHLORIDE/TOTAL DIOXIDE ANALYZER
K790653 · CGZ
Nova Corp.
Chemistry · 71d
Cleared Jun 15, 1979
ABUSCREEN RIA FOR PHENCYCLIDINE
K790655 · LCL
Hoffmann-La Roche, Inc.
Toxicology · 71d
Cleared Jun 15, 1979
PROPHYLAXIS ANGLE
K790722 · EGS
Young Dental Manufacturing Co. 1, LLC
Dental · 66d
Cleared Jun 15, 1979
PROPHYLAXIS CUPS AND POLISHERS
K790723 · EHK
Young Dental Manufacturing Co. 1, LLC
Dental · 66d
Cleared Jun 15, 1979
PREGNOSTICON PREGNANCY TEST KIT
K790734 · JHJ
Organon, Inc.
Chemistry · 60d
Cleared Jun 15, 1979
CHEMTAB
K790772 · JIM
Boehringer Mannheim Corp.
Chemistry · 56d
Cleared Jun 15, 1979
ENZYMATIC TRIGLYCERIDES-S.V.R.
K790773 · CDT
Calbiochem-Behring Corp.
Chemistry · 56d