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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
26377–26400 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 2018
A7 Anesthesia System
K171292 · BSZ
Shenzhen Mindray Bio-Medical...
Anesthesiology · 255d
Cleared Jan 12, 2018
A5 Anesthesia System
K171311 · BSZ
Shenzhen Mindray Bio-Medical...
Anesthesiology · 255d
Cleared Jan 12, 2018
IRRIS (Infra-Red-Red Intubation System)
K171411 · BTR
A.R Guide IN Medical , Ltd.
Anesthesiology · 242d
Cleared Jan 12, 2018
MSD CRP Assay Kit and MESO SECTOR S 700 Instrument
K171498 · DCN
Meso Scale Diagnostics, LLC
Immunology · 234d
Cleared Jan 12, 2018
Single Lumen Ovum Aspiration Needles
K171625 · MQE
Willian A. Cook Australia Pty, Ltd.
Obstetrics & Gynecology · 224d
Cleared Jan 12, 2018
HBS2 Headless Bone Screw
K171628 · HWC
Stuckenbrock Medizintechnik GmbH
Orthopedic · 224d
Cleared Jan 12, 2018
PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE
K171958 · DZI
Mectron S.P.A.
Dental · 197d
Cleared Jan 12, 2018
ipsogen JAK2 RGQ PCR Kit
K172287 · PSU
Qiagen, Inc.
Pathology · 168d
Cleared Jan 12, 2018
ARBOR External Fixation System
K172438 · KTT
Globus Medical, Inc.
Orthopedic · 154d
Cleared Jan 12, 2018
Wiltrom Spinal Fixation System
K172548 · NKB
Wiltrom Corporation Limited
Orthopedic · 142d
Cleared Jan 12, 2018
T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN...
K172774 · HSB
Stryker Trauma GmbH
Orthopedic · 120d
Cleared Jan 12, 2018
cobas Factor II and Factor V Test
K172913 · NPR
Roche Molecular Systems, Inc.
Hematology · 109d
Cleared Jan 12, 2018
6440 Ultrasound System
K173291 · IYN
Esaote, S.P.A.
Radiology · 88d
Cleared Jan 12, 2018
K-Y Silicone
K173504 · NUC
Reckitt Benckiser, LLC
Obstetrics & Gynecology · 60d
Cleared Jan 12, 2018
ImagenUniversal
K173547 · KPS
Cardiovascular Imaging Technologies
Radiology · 57d
Cleared Jan 12, 2018
Microcatheter
K173560 · DQY
Surmodics,Inc.
Cardiovascular · 56d
Cleared Jan 12, 2018
Illumeo System
K173588 · LLZ
Philips Medical Systems Technologies...
Radiology · 53d
Cleared Jan 12, 2018
Optima XR240amx, AutoGrid
K173602 · IZL
Ge Medical Systems, LLC
Radiology · 52d
Cleared Jan 12, 2018
syngo.via RT Image Suite
K173635 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Jan 12, 2018
HI-TORQUE TurnTrac Guide Wire Family
K173795 · DQX
Abbott Vascular
Cardiovascular · 29d
Cleared Jan 12, 2018
GU60A & GU60A-65
K173828 · KPR
Samsung Electronics Co., Ltd.
Radiology · 25d
Cleared Jan 11, 2018
ET Hybrid Abutment
K170421 · NHA
Hiossen, Inc.
Dental · 332d
Cleared Jan 11, 2018
GLOBAL UNITE Platform Shoulder System
K170748 · PHX
Depuy Ireland UC
Orthopedic · 307d
Cleared Jan 11, 2018
CEREC Ortho Software
K171122 · PNN
Dentsply Sirona
Dental · 269d