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
14089–14112 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 2022
Med-link Pulse Oximeter
K212752 · DQA
Shenzhen Med-Link Electronics Tech...
Anesthesiology · 263d
Cleared May 20, 2022
CalcShift™ Displacement Calcaneal Osteotomy System
K212979 · HRS
Nextremity Solutions, Inc.
Orthopedic · 245d
Cleared May 20, 2022
Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set
K213540 · DWF
Qura S.R.L
Cardiovascular · 193d
Cleared May 20, 2022
Diode Laser Therapy Systems
K220381 · GEX
Beijing Lasertell Medical Co., Ltd.
General & Plastic Surgery · 99d
Cleared May 20, 2022
7D Surgical System - Percutaneous Application (7D Flash Frame)
K220522 · OLO
7D Surgical
Orthopedic · 86d
Cleared May 20, 2022
iovera System
K220656 · GXH
Pacira Biosciences, Inc.
Neurology · 74d
Cleared May 20, 2022
syngo Dynamics (Version VA40E)
K220832 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 59d
Cleared May 20, 2022
Artisan Bone Plug, Universal Cement Restrictor
K220838 · LZN
Howmedica Osteonics, Dba Stryker...
Orthopedic · 59d
Cleared May 19, 2022
Alinity i STAT High Sensitivity Troponin-I
K202525 · MMI
Abbott Laboratories Diagnostics Division
Chemistry · 625d
Cleared May 19, 2022
ARCHITECT Toxo IgG
K210596 · LGD
Abbott Laboratories
Microbiology · 444d
Cleared May 19, 2022
BD Epilor Syringe
K210983 · CAZ
Becton, Dickinson and Company
Anesthesiology · 413d
Cleared May 19, 2022
RevoLix HTL
K211534 · GEX
Lisa Laser Products GmbH
Gastroenterology & Urology · 366d
Cleared May 19, 2022
OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A...
K211869 · LOD
Ormed Grup Medikal Turizm Saglik...
Orthopedic · 337d
Cleared May 19, 2022
CoverScan v1
K212565 · LLZ
Perspectum, Ltd.
Radiology · 279d
Cleared May 19, 2022
Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection
K213174 · PIF
Cardinalhealth
Gastroenterology & Urology · 233d
Cleared May 19, 2022
Artiglass NRFitTM Tip L.O.R. Glass Syringes
K213800 · QEH
Artiglass Srl
Anesthesiology · 164d
Cleared May 19, 2022
PINE Pedicle Screw System
K220285 · NKB
Tdm Co., Ltd.
Orthopedic · 107d
Cleared May 19, 2022
Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)
K220370 · FMK
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 99d
Cleared May 19, 2022
PAPAYA 3D & PAPAYA 3D Plus
K220392 · OAS
Genoray Co., Ltd.
Radiology · 97d
Cleared May 19, 2022
PAPAYA & PAPAYA Plus
K220423 · MUH
Genoray Co., Ltd.
Radiology · 94d
Cleared May 19, 2022
Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand...
K220485 · HBC
The Anspach Effort, Inc.
Neurology · 91d
Cleared May 19, 2022
SMR Reverse Liner
K220792 · MBF
Lima Corporate S.P.A.
Orthopedic · 62d
Cleared May 19, 2022
Medical Surgical Mask (Planar type)
K220824 · FXX
Hunan Chopard Medical Devices Co., Ltd.
General Hospital · 59d
Cleared May 19, 2022
Accu-Chek Safe-T-Pro Plus Lancing Device
K220849 · FMK
Roche Diabetes Care, Inc.
General & Plastic Surgery · 57d