FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
27625–27648 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 2017
Anprolene AN75 Ethylene Oxide Gas Sterilizer
K170432 · FLF
Andersen Sterilizers, Inc.
General Hospital · 260d
Cleared Oct 31, 2017
ALOKA ARIETTA 850
K171708 · IYN
Hitachi Healthcare Americas Corporation
Radiology · 145d
Cleared Oct 31, 2017
Cianna Medical SAVI Scout Reflector and SAVI Scout System
K171767 · NEU
Cianna Medical, Inc.
General & Plastic Surgery · 139d
Cleared Oct 31, 2017
iFuse Implant System- iFuse Navigation
K172268 · OLO
SI-BONE, Inc.
Orthopedic · 96d
Cleared Oct 31, 2017
Sysmex CS-5100
K172333 · JPA
Siemens Healthcare Diagnostics...
Hematology · 90d
Cleared Oct 31, 2017
JO Gelato Flavored Personal Lubricants
K172447 · NUC
United Consortium
Obstetrics & Gynecology · 78d
Cleared Oct 31, 2017
Stryker Upper-Face AXS screws and Mid-Face AXS screws
K172572 · JEY
Stryker
Dental · 64d
Cleared Oct 31, 2017
IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)
K173080 · MAX
Huvexel Co. , Ltd.
Orthopedic · 32d
Cleared Oct 31, 2017
Rapid HB, Rapid LB, Rapid MB
K173318 · ELW
3M Deutschland GmbH
Dental · 11d
Cleared Oct 30, 2017
Crystal Vision
K163659 · FYD
I.C Medical, Inc.
General Hospital · 307d
Cleared Oct 30, 2017
AN85/AN86 EO Indicators
K170426 · JOJ
Andersen Sterilizers, Inc.
General Hospital · 259d
Cleared Oct 30, 2017
Bi-Ostetic Bioactive Glass Foam
K170917 · MQV
Berkeley Advanced Biomaterials
Orthopedic · 215d
Cleared Oct 30, 2017
Anorganic Bone Mineral with Collagen in Delivery Applicator
K171008 · NPM
Collagen Matrix, Inc.
Dental · 209d
Cleared Oct 30, 2017
Intellijoint HIP Generation 2B System
K171525 · OLO
Intellijoint Surgical, Inc.
Orthopedic · 158d
Cleared Oct 30, 2017
Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed
K171643 · NPL
Geistlich Pharma AG
Dental · 150d
Cleared Oct 30, 2017
Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging...
K172236 · MCW
Avinger, Inc.
Cardiovascular · 97d
Cleared Oct 30, 2017
Stethee Pro
K172296 · DQD
M3Dicine Pty , Ltd.
Cardiovascular · 91d
Cleared Oct 30, 2017
Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System
K172326 · JWH
Stryker Orthopaedics
Orthopedic · 90d
Cleared Oct 30, 2017
AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate...
K172351 · KWS
Encore Medical, L.P.
Orthopedic · 88d
Cleared CT Oct 30, 2017
ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit
K172402 · PGX
Luminex Corporation
Microbiology · 82d
Cleared Oct 30, 2017
SenoBright HD
K172404 · MUE
Ge Healthcare
Radiology · 82d
Cleared Oct 30, 2017
XIDF-AWS801, Angio Workstation, V7.0
K172646 · OWB
Toshibamedical Systems Corporation
Radiology · 59d
Cleared Oct 30, 2017
Flex-Thread Fibula Pin System
K172943 · HSB
Intrafuse, LLC
Orthopedic · 34d
Cleared Oct 27, 2017
Puritan Bennett 980 Ventilator System
K162738 · CBK
Covidien
Anesthesiology · 392d