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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
94273–94296 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 10, 1997
AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS
K964910 · JAQ
Alpha-Omega Services, Inc.
Radiology · 91d
Cleared Mar 10, 1997
VASCUTEK TWILLWEAVE VASCULAR GRAFT
K964959 · DSY
Vascutek, Ltd.
Cardiovascular · 89d
Cleared Mar 10, 1997
GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR
K964973 · DTN
Gish Biomedical, Inc.
Cardiovascular · 88d
Cleared Mar 10, 1997
INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL
K965040 · HHW
Johnson & Johnson Medical, Inc.
Obstetrics & Gynecology · 83d
Cleared Mar 10, 1997
3M 1830 FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK AND 3M 1830FS FLUID BLOCK...
K965043 · FXX
Minnesota Mining and Mfg. Co.
General Hospital · 83d
Cleared Mar 10, 1997
ROUND WINDOW CATH
K965115 · ETD
Neuro-Biometrix, Inc.
Ear, Nose, Throat · 80d
Cleared Mar 10, 1997
FLAT CLOSED WOUND DRAIN WITH TROCAR
K965146 · GBX
Axiom Medical, Inc.
General & Plastic Surgery · 77d
Cleared Mar 10, 1997
SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT,...
K965240 · JJE
Beckman Instruments, Inc.
Chemistry · 70d
Cleared Mar 10, 1997
TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE...
K970100 · MJX
Simplicity Diagnostics, Inc.
Microbiology · 59d
Cleared Mar 10, 1997
PRESBYTERIAN LINEN SERVICES SURGICAL PACKS
K970286 · LRO
Medline Industries, Inc.
General & Plastic Surgery · 45d
Cleared Mar 10, 1997
EPISCREEN
K970357 · PJD
Epitope, Inc.
Microbiology · 39d
Cleared Mar 10, 1997
MITEK SUTURE RETROGRADER
K970360 · HWQ
Mitek Products
Orthopedic · 38d
Cleared Mar 10, 1997
SPARFLOZACIN, 5 MCG, SENSI-DISC
K970385 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 35d
Cleared Mar 10, 1997
HUMAN CHORIONIC GONADOTROPIN METHOD
K970387 · DHA
Dade Chemistry Systems, Inc.
Chemistry · 35d
Cleared Mar 10, 1997
HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT
K970477 · CFE
Sebia
Chemistry · 31d
Cleared Mar 10, 1997
LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL
K970666 · DIF
Bio-Rad
Chemistry · 14d
Cleared Mar 07, 1997
MODEL 700
K944180 · DSH
Memtec Corp.
Cardiovascular · 924d
Cleared Mar 07, 1997
SPECKTIN-LA TEST SET
K961892 · GFO
Analytical Control Systems, Inc.
Hematology · 295d
Cleared Mar 07, 1997
SHARPLAN RUBY LASER SYSTEM
K962446 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 256d
Cleared Mar 07, 1997
DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE
K962545 · KCT
Sterilization Cassette Systems, Inc.
General Hospital · 252d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY
K962578 · LLL
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY
K962719 · LLL
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY
K962720 · LLL
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY
K962722 · LLL
Hycor Biomedical, Inc.
Immunology · 249d