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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68497–68520 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 10, 2004
ORAVIVE TOOTH REVITALIZING PASTE
K040473 · LBH
Novamin Technology, Inc.
Dental · 15d
Cleared Mar 09, 2004
PROFILE 1320 LASER SYSTEM
K032459 · GEX
Sciton, Inc
General & Plastic Surgery · 211d
Cleared Mar 09, 2004
ARROWHEAD SPINAL SYSTEM
K032560 · NKB
Medtronic Sofamor Danek
Orthopedic · 202d
Cleared Mar 09, 2004
SOHNIKS
K033191 · FAJ
Sohniks Endoscopy, Inc.
Gastroenterology & Urology · 160d
Cleared Mar 09, 2004
BONESAVE BONE VOID FILLER
K033258 · MQV
Howmedica Osteonics
Orthopedic · 152d
Cleared Mar 09, 2004
MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POWDER FREE FOR CHEMOTHERAPY USE
K033496 · LYY
Industrial Clothings, Ltd.
General Hospital · 125d
Cleared Mar 09, 2004
INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER
K033807 · DRQ
Draeger Medical Systems, Inc.
Cardiovascular · 92d
Cleared Mar 09, 2004
BD PROBETEC ET LEGIONELLA PNEUMOPHILA (LP) AMPLIFIED DNA ASSAY
K033861 · LQH
Becton, Dickinson & CO
Microbiology · 88d
Cleared Mar 09, 2004
ULTRAFLEX INFUSION SET
K033892 · FPA
Disetronic Medical Systems AG
General Hospital · 84d
Cleared Mar 09, 2004
TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P
K033967 · LHQ
Flir Systems
Radiology · 78d
Cleared Mar 09, 2004
LACRYTEST
K034057 · DGC
Adiatec SA
Immunology · 70d
Cleared Mar 09, 2004
SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE
K034059 · LLZ
Sectra AB
Radiology · 69d
Cleared Mar 09, 2004
STEERABLE STYLET
K040001 · DRB
Synovis Surgical Innovations
Cardiovascular · 67d
Cleared Mar 09, 2004
THERILINK BONE VOID FILLER
K040134 · MQV
Therics, Inc.
Orthopedic · 48d
Cleared Mar 09, 2004
VERSAPOINT RESECTOSCOPIC SYSTEM
K040302 · HIH
Gynecare, A Div. of Ethicon, Inc.
Obstetrics & Gynecology · 29d
Cleared Mar 09, 2004
SIREMOBIL ISO-C 3D
K040347 · OXO
Siemens Medical Systems, Inc.
Radiology · 26d
Cleared Mar 09, 2004
MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL
K040348 · MOS
Mri Devices Corp.
Radiology · 26d
Cleared Mar 09, 2004
MODIFICATION TO HRW-127 WRIST ARRAY COIL
K040349 · MOS
Mri Devices Corp.
Radiology · 26d
Cleared Mar 09, 2004
FLEBOSET MULTIPLE
K040456 · LHI
Laboratorios Grifols, S.A.
General Hospital · 15d
Cleared Mar 09, 2004
SONOLINE EBISU DIAGNOSTIC ULTRASOUND SYSTEMS
K040502 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 11d
Cleared Mar 08, 2004
SMART KLAMP VARIOUS BY SIZE
K032091 · HFX
Emergogroup, Inc.
Obstetrics & Gynecology · 245d
Cleared Mar 08, 2004
ZTI IMPLANTS SYSTEM, DRM IMPLANTS
K034067 · DZE
Drm Research Laboratories, Inc.
Dental · 68d
Cleared Mar 08, 2004
AMEDITECH IMMU TEST DRUG SCREEN PANEL
K040092 · DKZ
Ameditech, Inc.
Toxicology · 52d
Cleared Mar 08, 2004
QUANTA PLEX SLE PROFILE 8
K040160 · LLL
Inova Diagnostics, Inc.
Immunology · 45d