FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
94777–94800 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 1997
KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE
K970427 · FGB
Karl Storz Endoscopy
Gastroenterology & Urology · 35d
Cleared Mar 11, 1997
ADAPTIVE COMPRESSION - CLASS D/ CLASS D AGCI
K970430 · ESD
Midwest City Hearing Aid Center
Ear, Nose, Throat · 35d
Cleared Mar 11, 1997
URIC ACID (LIQUID) REAGENT SET
K970560 · KNK
Pointe Scientific, Inc.,
Chemistry · 26d
Cleared Mar 10, 1997
PULSEMASTER
K961269 · GEX
American Dental Technologies, Inc.
General & Plastic Surgery · 342d
Cleared Mar 10, 1997
IMMULITE OPIATES SCREEN/CONTROL MODULE
K962323 · DJG
Diagnostic Products Corp.
Toxicology · 266d
Cleared Mar 10, 1997
NASP HYDROCOLLOID DRESSING (REGULAR OR THIN)
K964231 · KMF
North American Sterilization &...
General & Plastic Surgery · 138d
Cleared Mar 10, 1997
R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM
K964538 · LJT
Boston Scientific Corp
General Hospital · 118d
Cleared Mar 10, 1997
PVK-720ST ENDOCAVITARY TRANSDUCER
K964865 · ITX
Toshiba America Medical Systems, In.C
Radiology · 96d
Cleared Mar 10, 1997
ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS
K964909 · ETB
Xomed, Inc.
Ear, Nose, Throat · 91d
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