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
84121–84144 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 1999
INNOVAQUARTZ GENERAL SHAPE LASER FIBER
K994010 · GEX
Innovaquartz
General & Plastic Surgery · 21d
Cleared Dec 16, 1999
FRUCTOSAMINE, MODEL FR 106-01
K991246 · LCP
A.P. Total Care, Inc.
Chemistry · 248d
Cleared Dec 16, 1999
VERDICT -II OPIATES 2000
K992111 · DJG
Medtox Diagnostics, Inc.
Toxicology · 177d
Cleared Dec 16, 1999
COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY
K992552 · LIP
DiaSorin, Inc.
Microbiology · 139d
Cleared Dec 16, 1999
SURE-WAY REUSABLE SHARPS CONTAINER
K992626 · FMI
Sure-Way Systems, Inc.
General Hospital · 133d
Cleared Dec 16, 1999
PATIENT LATEX EXAMINATION POWDER-FREE POLYMER COATED GLOVES
K992676 · LYY
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 128d
Cleared Dec 16, 1999
PATIENT LATEX EXAMINATION GLOVE POWDERED & POWDER FREE, STERILE
K992681 · LYY
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 128d
Cleared Dec 16, 1999
INTRAY GC
K993033 · JTY
Biomed Diagnostics, Inc.
Microbiology · 98d
Cleared Dec 16, 1999
TALON ANCHOR SNAP-PAK
K993327 · DZL
Mitek Products
Dental · 73d
Cleared Dec 16, 1999
CLEARPLAN EASY II HOME PREGNANCY TEST
K993333 · LCX
Unipath , Ltd.
Chemistry · 73d
Cleared Dec 16, 1999
PALL SUPOR AEF FILTER
K993379 · FPB
Pall Corp.
General Hospital · 70d
Cleared Dec 16, 1999
WAKO L-TYPE GOT TEST
K993468 · CIT
Wako Chemicals USA, Inc.
Chemistry · 64d
Cleared Dec 16, 1999
BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12
K993571 · CDD
Bayer Corp.
Chemistry · 56d
Cleared Dec 16, 1999
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC...
K993711 · JZG
Bayer Corp.
Chemistry · 43d
Cleared Dec 16, 1999
MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH
K993764 · KCT
Medipack Medical Packaging Mfg. Co.
General Hospital · 38d
Cleared Dec 16, 1999
PARAPOST SYSTEM STERILIZABLE ORGANIZER
K993835 · FRG
Coltene/Whaledent, Inc.
General Hospital · 34d
Cleared Dec 16, 1999
AVL OPTI CRITICAL CARE ANALYZER
K993837 · CGA
Avl Scientific Corp.
Chemistry · 34d
Cleared Dec 16, 1999
IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6
K993952 · LFZ
Diagnostic Products Corp.
Microbiology · 24d
Cleared Dec 16, 1999
AT WORK DRUG TEST, MODEL 9145-25C
K994093 · LCL
Phamatech
Toxicology · 13d
Cleared Dec 15, 1999
QMS MAPPING SYSTEM,MODEL 2000
K990058 · DQK
Cathdata, Inc.
Cardiovascular · 342d
Cleared Dec 15, 1999
ATR 3000, ATR 2000, IMPLANT-PRO
K991401 · EFB
Advanced Technology Research (A.T.R.)...
Dental · 237d
Cleared Dec 15, 1999
ACUNAV DIAGNOSTIC ULTRASOUND CATHETER
K992631 · DQO
Acuson Corp.
Radiology · 131d
Cleared Dec 15, 1999
BREMER HALO SYSTEM TITANIUM SKULL PIN
K993099 · JEC
Depuyacromed
Orthopedic · 90d
Cleared Dec 15, 1999
TRIP TONOMETRY CATHETER, 14F
K993296 · KNT
Datex-Ohmeda, Inc.
Gastroenterology & Urology · 75d