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
78001–78024 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 2001
EZ SYRINGE
K011951 · FMF
Owen Mumford, Ltd.
General Hospital · 42d
Cleared Aug 02, 2001
SOMNO STAR & SERIES SLEEP SYSTEM
K012085 · OLV
Sensor Medics Corp.
Neurology · 30d
Cleared Aug 01, 2001
CENTRAL VENOUS CATHETER
K003839 · LJS
Boston Scientific Corp
General Hospital · 232d
Cleared Aug 01, 2001
MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION
K010300 · GZB
Medtronic Vascular
Neurology · 181d
Cleared Aug 01, 2001
WAKO IMMUNOASSAY CALIBRATOR SET
K010332 · JIT
Wako Chemicals USA, Inc.
Immunology · 180d
Cleared Aug 01, 2001
THE ALBERTA LENS SM2, SULFOCON B
K010454 · HQD
Progressive Optical Research , Ltd.
Ophthalmic · 167d
Cleared Aug 01, 2001
AUTOMATED WORKCELL CONTROL SOFTWARE
K010500 · JJE
Lab-Interlink, Inc.
Chemistry · 161d
Cleared Aug 01, 2001
CANNULATED PLUS SCREW SYSTEM
K010738 · HWC
Orthomatrix, Inc.
Orthopedic · 142d
Cleared Aug 01, 2001
MEDICON TITANIUM YASARGIL ANEURYSM CLIPS
K010908 · HCH
Medicon EG
Neurology · 128d
Cleared Aug 01, 2001
MEDICON YASARGIL CLIP APPLYING FORCEPS
K010910 · HCI
Medicon EG
Neurology · 128d
Cleared Aug 01, 2001
SPARC SLING SYSTEM
K011251 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 99d
Cleared Aug 01, 2001
AESCULAP, INC. SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE
K011372 · GAM
Aesculap, Inc.
General & Plastic Surgery · 89d
Cleared Aug 01, 2001
ARTHREX BIO-POST AND WASHER
K011495 · MAI
Arthrex, Inc.
Orthopedic · 78d
Cleared Aug 01, 2001
ORTHO VLC
K011521 · DYH
First Scientific Limited
Dental · 76d
Cleared Aug 01, 2001
POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR
K011791 · LZA
Latexx Partners Bhd.
General Hospital · 54d
Cleared Aug 01, 2001
NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
K011792 · LZA
Latexx Partners Bhd.
General Hospital · 54d
Cleared Aug 01, 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
K012056 · FGE
Cordis Europa, N.V.
Gastroenterology & Urology · 30d
Cleared Aug 01, 2001
8100/8500 VITAL SIGNS MONITOR
K012059 · MWI
Criticare Systems, Inc.
Cardiovascular · 30d
Cleared Aug 01, 2001
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
K012066 · FGE
Sulzer Intratherapeutics, Inc.
Gastroenterology & Urology · 30d
Cleared Aug 01, 2001
MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT
K012069 · JXE
Neurotron Medical, Inc.
Neurology · 30d
Cleared Aug 01, 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
K012087 · FGE
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Aug 01, 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
K012090 · FGE
Cordis, A Johnson & Johnson Co.
Gastroenterology & Urology · 27d
Cleared Aug 01, 2001
PROTECTIV ACUVANCE IV CATHETER SYSTEM
K012128 · FOZ
Ethicon Endo-Surgery, Inc.
General Hospital · 23d
Cleared Aug 01, 2001
POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM...
K012135 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 23d