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
84529–84552 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 15, 1999
REDI-TEST OPIATES
K991883 · DJG
Advantage Diagnostics Corp.
Toxicology · 105d
Cleared Sep 15, 1999
BOLUS ACCESSORY SET
K992072 · FPA
I-Flow Corp.
General Hospital · 88d
Cleared Sep 15, 1999
NAC PRN NEEDLELESS ACCESS CONNECTOR
K992268 · FPA
The Kipp Group
General Hospital · 71d
Cleared Sep 15, 1999
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
K992399 · CIX
Bayer Corp.
Chemistry · 58d
Cleared Sep 15, 1999
CARESIDE CO2, TOTAL
K992475 · KHS
Careside, Inc.
Chemistry · 51d
Cleared Sep 15, 1999
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM,...
K992755 · FGE
Cordis, A Johnson & Johnson Co.
Gastroenterology & Urology · 30d
Cleared Sep 15, 1999
CYNOSURE ACCOLADE LASER
K992814 · GEX
Cynosure, Inc.
General & Plastic Surgery · 26d
Cleared Sep 15, 1999
CORDIS EXTREME PTA BALLOON CATHETER
K992825 · LIT
Cordis Corp.
Cardiovascular · 23d
Cleared Sep 15, 1999
AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE...
K992910 · DTZ
Medtronic Vascular
Cardiovascular · 16d
Cleared Sep 14, 1999
HELICA TC
K972267 · GEI
Tenerco, Inc.
General & Plastic Surgery · 819d
Cleared Sep 14, 1999
HAMILTON MEDICAL GALILEOVENTILATOR
K982910 · CBK
Hamilton Medical, Inc.
Anesthesiology · 392d
Cleared Sep 14, 1999
HYDROFERA BACTERISTATIC NASAL DRESSING
K983276 · EMX
Hydrofera, LLC
Ear, Nose, Throat · 362d
Cleared Sep 14, 1999
LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00
K990212 · DYX
Doctor'S Research Group, Inc.
Dental · 235d
Cleared Sep 14, 1999
DANEK PLATE AND SCREW SYSTEM
K991036 · MNH
Sofamor Danek USA,Inc.
Orthopedic · 169d
Cleared Sep 14, 1999
MADTRONIC DLP ARTERIAL CANNULAE
K991066 · DWF
Medtronic Vascular
Cardiovascular · 167d
Cleared Sep 14, 1999
SAUFLON AEROTAB DISINFECTING SYSTEM FOR THE DISINFECTION OF SOFT...
K991125 · LPN
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 165d
Cleared Sep 14, 1999
MODIFIED HAM'S F-10 BASAL MEDIUM, MODIFIED HAMS'S F-10 BASAL MEDIUM HEPES,...
K991419 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 144d
Cleared Sep 14, 1999
CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400
K991529 · GEI
Conway Stuart Medical, Inc.
General & Plastic Surgery · 134d
Cleared Sep 14, 1999
LUMENON XENON LIGHT SOURCE
K992050 · GCT
Walter Lorenz Surgical, Inc.
Gastroenterology & Urology · 89d
Cleared Sep 14, 1999
PREMIER ANTERIOR CERVICAL PLATE SYSTEM
K992110 · KWQ
Sofamor Danek USA
Orthopedic · 84d
Cleared Sep 14, 1999
DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH...
K992128 · LYY
Dash Medical Gloves Sdn Bhd
General Hospital · 83d
Cleared Sep 14, 1999
COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT...
K992171 · KGO
Allegiance Healthcare Corp.
General Hospital · 78d
Cleared Sep 14, 1999
DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS
K992302 · MGP
Dermaphylyx, Inc.
General & Plastic Surgery · 68d
Cleared Sep 14, 1999
SCHOELLY RIGID ENDOSCOPES
K992437 · GCJ
Fiber Imaging Technologies, Inc.
General & Plastic Surgery · 54d