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
77497–77520 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 2001
MALE LATEX CONDOM
K012653 · HIS
Qingdao Shuang Die Latex Production...
Obstetrics & Gynecology · 39d
Cleared Sep 21, 2001
COLLAGEN NERVE CUFF
K012814 · JXI
Collagen Matrix, Inc.
Neurology · 30d
Cleared Sep 21, 2001
NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH BLUEBERRY SCENTED...
K012857 · LYY
Sgmp Co., Ltd.
General Hospital · 28d
Cleared Sep 21, 2001
POWDER-FREE LATEX EXAM GLOVES WITH CHOCOLATE SCENTING AND PROTEIN LABELING...
K012860 · LYY
Sgmp Co., Ltd.
General Hospital · 28d
Cleared Sep 21, 2001
NON-STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH VANILLA AND PROTEIN...
K012863 · LYY
Sgmp Co., Ltd.
General Hospital · 28d
Cleared Sep 21, 2001
ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION
K012904 · GKZ
Bayer Diagnostics Corp.
Hematology · 23d
Cleared Sep 20, 2001
COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X...
K000122 · MQV
Neucoll, Inc.
Orthopedic · 611d
Cleared Sep 20, 2001
QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM
K002241 · DZE
Quantum Bioengineering, Ltd.
Dental · 423d
Cleared Sep 20, 2001
GSA GENITO SENSORY ANALYZER
K010981 · LLN
Medoc Ltd. Advanced Medical Systems
Neurology · 171d
Cleared Sep 20, 2001
QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM
K011223 · DZE
Paxmed International
Dental · 153d
Cleared Sep 20, 2001
INSIGHT MILLENNIUM PLUS
K011964 · HCC
Fasstech
Neurology · 87d
Cleared Sep 20, 2001
SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C
K011988 · OCL
Cardiofocus, Inc.
Cardiovascular · 86d
Cleared Sep 20, 2001
MODIFICATION TO LR 5200 FILM RECORDER
K012010 · LMC
Agfa Corp.
Radiology · 85d
Cleared Sep 20, 2001
MULTIFUNCTION ENDOSCOPIC INSTRUMENT
K012033 · GEI
Seedling Enterprises., LLC
General & Plastic Surgery · 83d
Cleared Sep 20, 2001
KINETIC CANNULA
K012042 · QPB
Reliance Medical Corp.
General & Plastic Surgery · 83d
Cleared Sep 20, 2001
OPTIBOND SOLO PLUS ACTIVATOR
K012082 · KLE
Sybron Dental Specialties, Inc.
Dental · 79d
Cleared Sep 20, 2001
PRECLUDE PERICARDIAL MEMBRANE
K012098 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 77d
Cleared Sep 20, 2001
PATTON ENDO-BAG
K012150 · GCJ
Patton Medical Corp.
General & Plastic Surgery · 72d
Cleared Sep 20, 2001
REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT
K013018 · MID
Corgenix, Inc.
Immunology · 13d
Cleared Sep 20, 2001
QUANTUM VERSATILITY IMPLANT SYSTEM
K991250 · DZE
Quantum Bioengineering, Ltd.
Dental · 891d
Cleared Sep 19, 2001
NSI HEXED AND NON-HEXED IMPLANT SYSTEM
K003620 · DZE
Nsi
Dental · 301d
Cleared Sep 19, 2001
ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE
K011087 · FMF
Orthovita, Inc.
General Hospital · 162d
Cleared Sep 19, 2001
NEUROSOFT'S SOURCE
K011241 · OLX
Neurosoft, Inc.
Neurology · 149d
Cleared Sep 19, 2001
IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR
K011943 · LZN
Kensey Nash Corp.
Orthopedic · 90d