FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
125593–125616 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 1990
EXTENDED CHIN IMPLANT STYLE II
K902825 · FWP
Implantech Associates, Inc.
General & Plastic Surgery · 34d
Cleared Aug 01, 1990
ANATOMICAL MANDIBULAR IMPLANT STYLE I
K902826 · FWP
Implantech Associates, Inc.
General & Plastic Surgery · 34d
Cleared Aug 01, 1990
ANATOMICAL MANDIBULAR IMPLANT STYLE II
K902827 · FWP
Implantech Associates, Inc.
General & Plastic Surgery · 34d
Cleared Aug 01, 1990
FASTRECON 88 PERIFERAL
K902848 · JAK
Scientific Technology , Ltd.
Radiology · 34d
Cleared Aug 01, 1990
POST CEMENT (DENTAL COMPOSITE)
K902894 · EMA
Medical Device Inspection Co., Inc.
Dental · 30d
Cleared Aug 01, 1990
MODIFIED COAG-1 PT TEST CARD
K903019 · GJS
Cardiovascular Diagnostic Services
Hematology · 21d
Cleared Aug 01, 1990
LATEX SURGICAL STERILE GLOVES
K903212 · KGO
Mirage Medical & Chemical, Inc.
General Hospital · 21d
Cleared Jul 31, 1990
SPBC SERIES SINGLE PASS BLOOD CARDIOPLEGIA SYSTEM
K896807 · DTR
Gish Biomedical, Inc.
Cardiovascular · 239d
Cleared Jul 31, 1990
ZAP-GUARD
K896985 · DRL
Guardian Angel Products, Inc.
Cardiovascular · 230d
Cleared Jul 31, 1990
MICRORING YT
K900112 · JXB
Medical Wire & Equipment Co.
Microbiology · 203d
Cleared Jul 31, 1990
EPICARDIA 4000
K900207 · DST
Medicomp, Inc.
Cardiovascular · 196d
Cleared Jul 31, 1990
APPLICARD (EKG)
K900459 · DRY
Medi-Globe Corp.
Cardiovascular · 182d
Cleared Jul 31, 1990
PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE
K900682 · DRY
Contour Electrodes, Inc.
Cardiovascular · 168d
Cleared Jul 31, 1990
IONOMETER EF-HK AND ACCESSORIES
K901042 · JGS
Fresenius USA, Inc.
Chemistry · 147d
Cleared Jul 31, 1990
TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES
K901247 · DYG
Intec Medical, Inc.
Cardiovascular · 138d
Cleared Jul 31, 1990
HEWLETT-PACKARD SERIES OF DISPOSABLE NIBP CUFFS
K901252 · DXQ
Hewlett-Packard Co.
Cardiovascular · 137d
Cleared Jul 31, 1990
ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM
K901994 · EFW
Rosofsky & Ross, Inc.
Dental · 90d
Cleared Jul 31, 1990
FUJI LINING CEMENT LIGHT CURE
K901999 · EJK
G-C Intl. Corp.
Dental · 90d
Cleared Jul 31, 1990
MOVABLE CORE GUIDEWIRE
K902152 · DQX
Guidewire Technologies, Inc.
Cardiovascular · 77d
Cleared Jul 31, 1990
TEFLON COATED GUIDEWIRE
K902153 · DQX
Guidewire Technologies, Inc.
Cardiovascular · 76d
Cleared Jul 31, 1990
COULTER HDL - CHOLESTEROL REAGENT
K902174 · LBR
Coulter Corp.
Chemistry · 78d
Cleared Jul 31, 1990
DMA TRIGLYCERIDE (GPO) PROCEDURE
K902202 · JGY
Data Medical Associates, Inc.
Chemistry · 76d
Cleared Jul 31, 1990
SUBCLAVIAN INTRODUCER SET
K902251 · DYB
Infusaid Corp.
Cardiovascular · 76d
Cleared Jul 31, 1990
CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY
K902270 · LJC
Ciba Corning Diagnostics Corp.
Microbiology · 71d