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
77617–77640 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 01, 2001
CEREC3 VITABLOCKS
K012517 · ELW
Sirona Dental Systems GmbH
Dental · 87d
Cleared Nov 01, 2001
KSEA SIALOENDOSCOPES AND ACCESSORIES
K012527 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 87d
Cleared Nov 01, 2001
PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT
K012761 · EBC
Prime Dental Manufacturing, Inc.
Dental · 76d
Cleared Nov 01, 2001
S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL
K012767 · ELW
S & C Polymer GmbH
Dental · 76d
Cleared Nov 01, 2001
BIOPORTA G, MODEL 2052
K012826 · EJT
Wieland Edelmetalle GmbH & Co.
Dental · 70d
Cleared Nov 01, 2001
PORTA AURIUM, MODEL 2067
K012827 · EJT
Wieland Edelmetalle GmbH & Co.
Dental · 70d
Cleared Nov 01, 2001
PORTA SMK 82, MODEL 2032
K012828 · EJS
Wieland Edelmetalle GmbH & Co.
Dental · 70d
Cleared Nov 01, 2001
BIO PORTADUR, ORDER-NO.:2017
K012831 · EJT
Wieland Edelmetalle GmbH & Co.
Dental · 70d
Cleared Nov 01, 2001
PORTA GEO TI MODEL #2004
K012834 · EJT
Wieland Edelmetalle GmbH & Co.
Dental · 70d
Cleared Nov 01, 2001
PORTA MAXIMUM, MODEL# 2066
K012835 · EJT
Wieland Edelmetalle GmbH & Co.
Dental · 70d
Cleared Oct 31, 2001
OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION...
K010202 · GXD
Leslie W. Organ
Neurology · 282d
Cleared Oct 31, 2001
PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET
K011221 · KDI
Gambro Renal Products
Gastroenterology & Urology · 194d
Cleared Oct 31, 2001
MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE...
K011761 · DYB
Arrow Intl., Inc.
Cardiovascular · 147d
Cleared Oct 31, 2001
SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40...
K011916 · MSD
Horizon Medical Products, Inc.
Gastroenterology & Urology · 133d
Cleared Oct 31, 2001
OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTEMS
K012495 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Oct 31, 2001
ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH...
K012714 · LYY
Koon Seng Sdn Bhd
General Hospital · 78d
Cleared Oct 31, 2001
MODIFICATION TO: ECAT LSO PET/CT SCANNER
K013504 · KPS
Cti Pet Systems, Inc.
Radiology · 9d
Cleared Oct 30, 2001
PALAMED BONE CEMENT
K010586 · LOD
Merck Biomaterial GmbH
Orthopedic · 245d
Cleared Oct 30, 2001
ULTRASOUND TRANSDUCER COVER
K011265 · ITX
Advance Medical Designs, Inc.
Radiology · 188d
Cleared Oct 30, 2001
SOVEREIGN
K011476 · INI
Shoprider Intl., Inc.
Physical Medicine · 169d
Cleared Oct 30, 2001
CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1
K012497 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 88d
Cleared Oct 30, 2001
SEPRAGEL SINUS
K012532 · LYA
Genzyme Corp.
Ear, Nose, Throat · 85d
Cleared Oct 30, 2001
VANGUARD REPROCESSED ARTHROSCOPIC WANDS
K012695 · GEI
Vanguard Medical Concepts, Inc.
General & Plastic Surgery · 77d
Cleared Oct 30, 2001
HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE
K012895 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 63d