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
83929–83952 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 07, 2000
SALTER AIRE COMPRESSOR
K992285 · CAF
Salter Labs
Anesthesiology · 184d
Cleared Jan 07, 2000
NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES
K992455 · DQA
Nihon Kohden America, Inc.
Anesthesiology · 168d
Cleared Jan 07, 2000
MAGSTIM RAPID
K992911 · GWF
Magstim Corporation US
Neurology · 130d
Cleared Jan 07, 2000
VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700)
K993039 · MRH
Bausch & Lomb, Inc.
Ophthalmic · 119d
Cleared Jan 07, 2000
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z44
K993426 · DXN
Rossmax International , Ltd.
Cardiovascular · 87d
Cleared Jan 07, 2000
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z40
K993429 · DXN
Rossmax International , Ltd.
Cardiovascular · 87d
Cleared Jan 07, 2000
THE AUTOTAC SYSTEM
K993493 · DZL
BioHorizons Implant Systems, Inc.
Dental · 84d
Cleared Jan 07, 2000
MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BILIARY STENT,...
K994156 · FGE
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Jan 07, 2000
AUTOMATED CORE BIOPSY DEVICE
K994272 · KNW
Promex, Inc.
Gastroenterology & Urology · 18d
Cleared Jan 07, 2000
ASCENT KNEE SYSTEM
K994326 · KWH
Biomet Manufacturing, Inc.
Orthopedic · 16d
Cleared Jan 06, 2000
BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP
K983866 · DSP
Belmont Instrument Corp.
Cardiovascular · 430d
Cleared Jan 06, 2000
MEDISYSTEMS BUTTONHOLE NEEDLE SETS
K990803 · FIE
Medisystems Corp.
Gastroenterology & Urology · 302d
Cleared Jan 06, 2000
PSI TITANIUM ANEURYSM CLIP
K991959 · HCH
V. Mueller Neuro/Spine
Neurology · 210d
Cleared Jan 06, 2000
CRITERION 40 OR PM 40
K992101 · CAP
Caradyne, Ltd.
Anesthesiology · 198d
Cleared Jan 06, 2000
BARD MEMOTHERM FLEXX BILIARY STENT
K993392 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 06, 2000
HDR CONTOUR TP TEMPLATE AND IMPLANT ACCESSORIES
K993400 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 90d
Cleared Jan 06, 2000
DISPOS-A-SCOPE
K993738 · FER
Dispos-A-Scope
Gastroenterology & Urology · 63d
Cleared Jan 06, 2000
HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00
K993778 · OCX
Northgate Technologies, Inc.
Gastroenterology & Urology · 59d
Cleared Jan 06, 2000
DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE...
K993892 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 51d
Cleared Jan 06, 2000
SIS WOUND DRESSING II
K993948 · KGN
Cook Biotech, Inc.
General & Plastic Surgery · 45d
Cleared Jan 05, 2000
ACCESS HYBRITECH FREE PSA QC, MODEL 37219
K993210 · JJX
Beckman Coulter, Inc.
Immunology · 103d
Cleared Jan 05, 2000
ENSTYLET MODELS EC0010, EC0020
K993376 · DRB
Endocardial Solutions, Inc.
Cardiovascular · 90d
Cleared Jan 05, 2000
OHMEDA MEDICAL OMNIBED
K993407 · FMZ
Ohmeda Medical
General Hospital · 89d
Cleared Jan 05, 2000
VARELISA TPO ANTIBODIES, MODEL 12348/12396
K993585 · JZO
Pharmacia & Upjohn Co.
Immunology · 75d