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
70729–70752 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 2003
VIANOX DELIVERY SYSTEM, MODEL I
K023014 · MRP
Pulmonox Medical, Inc.
Anesthesiology · 338d
Cleared Aug 14, 2003
MODIFICATION TO FRIALIT-2 DENTAL IMPLANT SYSTEM
K031674 · DZE
Friadent GmbH
Dental · 76d
Cleared Aug 14, 2003
STATCO2METER, MODEL 10-55372
K031814 · CCK
Mercury Medical
Anesthesiology · 63d
Cleared Aug 14, 2003
DVNET MDV-PACS
K031816 · LLZ
Dvnet International Technology Co., Ltd.
Radiology · 63d
Cleared Aug 14, 2003
PHILIPS FRESCO RELEASE 1
K031836 · LLZ
Philips Medical Systems North America...
Radiology · 62d
Cleared Aug 14, 2003
MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC
K031866 · JAI
Med-Tec,Inc.
Radiology · 59d
Cleared Aug 14, 2003
MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION
K031957 · LPN
Ciba Vision Corporation
Ophthalmic · 50d
Cleared Aug 14, 2003
ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS
K032080 · HIL
Rostam , Ltd.
Obstetrics & Gynecology · 38d
Cleared Aug 14, 2003
XIVE DENTAL IMPLANT SYSTEM MULTIPLE
K032158 · DZE
Friadent GmbH
Dental · 30d
Cleared Aug 14, 2003
DISPOSABLE POWDER FREE VINYL EXAM GLOVES
K032172 · LYZ
Synmertex Co, Ltd.
General Hospital · 29d
Cleared Aug 14, 2003
DISPOSABLE POWDERED VINYL EXAM GLOVES
K032190 · LYZ
Synmertex Co, Ltd.
General Hospital · 28d
Cleared Aug 14, 2003
XIVE TG DENTAL IMPLANT SYSTEM
K032284 · DZE
Friadent GmbH
Dental · 21d
Cleared Aug 14, 2003
ORTHOVIEW
K032401 · LLZ
Omsbar, Ltd.
Radiology · 10d
Cleared Aug 13, 2003
IVENT 201 PORTABLE VENTILATOR
K021981 · NOU
Versamed , Ltd.
Anesthesiology · 422d
Cleared Aug 13, 2003
PBN GUIDEWIRES
K031442 · DQX
Medical Device Technologies, Inc.
Cardiovascular · 99d
Cleared Aug 13, 2003
CONDUCTION CATHETER
K031600 · FRN
Micor, Inc.
General Hospital · 84d
Cleared Aug 13, 2003
IUR FLUID MANAGEMENT SYSTEM
K031616 · HIG
W.O.M. World of Medicine AG
Obstetrics & Gynecology · 82d
Cleared Aug 13, 2003
MODIFICATION TO CERASORB ORTHO
K031651 · MQV
Curasan AG
Orthopedic · 77d
Cleared Aug 13, 2003
VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE
K031865 · LON
bioMerieux, Inc.
Microbiology · 57d
Cleared Aug 13, 2003
COULTER LH 500 HEMATOLOGY ANALYZER
K032000 · GKZ
Beckman Coulter, Inc.
Hematology · 64d
Cleared Aug 13, 2003
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
K032073 · DYB
W.L. Gore & Associates, Inc.
Cardiovascular · 41d
Cleared Aug 13, 2003
MODIFICATION TO E-SCAN XQ
K032121 · LNH
Esaote, S.P.A.
Radiology · 35d
Cleared Aug 13, 2003
MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
K032246 · JSM
Starplex Scientific, Inc.
Microbiology · 22d
Cleared Aug 13, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS
K032296 · JIS
Ortho-Clinical Diagnostics, Inc.
Chemistry · 19d