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
14545–14568 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 2022
Nitrile Examination Gloves
K213843 · LZA
Dong Tai City Huayi Gloves Co., Ltd.
General Hospital · 112d
Cleared Mar 31, 2022
STATIM 6000B Vacuum Autoclave
K214057 · FLE
Scican , Ltd.
General Hospital · 94d
Cleared Mar 31, 2022
ARx® Spinal System
K220025 · NKB
Life Spine, Inc.
Orthopedic · 85d
Cleared Mar 31, 2022
PediGuard Threaded
K220160 · PDQ
Spineguard S.A.
Neurology · 71d
Cleared Mar 31, 2022
Uterine ElevatOR PRO with OccludOR Balloon
K220202 · LKF
The O R Company Pty, Ltd.
Obstetrics & Gynecology · 66d
Cleared Mar 31, 2022
Vinyl Co-Polymer Powder-free Examination Gloves, Black
K220240 · LYZ
Grand Work Plastic Products Co., Ltd.
General Hospital · 62d
Cleared Mar 31, 2022
Hercules Syndesmosis Implant System
K220260 · HTN
In2bones USA, LLC
Orthopedic · 59d
Cleared Mar 31, 2022
NEXXT SPINE NAVIGATION System
K220291 · OLO
Nexxt Spine, LLC
Orthopedic · 58d
Cleared Mar 31, 2022
Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy...
K220353 · LZC
Niujian Technology Co., Ltd.
General Hospital · 51d
Cleared Mar 31, 2022
BD Cathena Safety IV Catheter
K220584 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 30d
Cleared Mar 31, 2022
TargetCool
K220674 · GEH
Recensmedical, Inc.
General & Plastic Surgery · 23d
Cleared Mar 31, 2022
APX-24 Portable X-ray System
K220678 · IZL
Aspenstate, Inc.
Radiology · 23d
Cleared Mar 30, 2022
INTAI Surgical Mask (non-sterile)
K210422 · FXX
Intai Technology Corp.
General Hospital · 412d
Cleared CT Mar 30, 2022
EON
K211681 · PKT
Dominion Aesthetic Technologies, Inc.
General & Plastic Surgery · 302d
Cleared Mar 30, 2022
Shield System
K212159 · OWB
Radiaction , Ltd.
Radiology · 261d
Cleared Mar 30, 2022
Dukal Corporation AAMI Level 4 Open-Back Protective Gown
K212464 · QPC
Dukal Corporation
General Hospital · 236d
Cleared Mar 30, 2022
VERIQA
K213370 · IYE
Ptw-Freiburg...
Radiology · 169d
Cleared Mar 30, 2022
CareTaker Monitor App
K213699 · DXN
Caretaker Medical, LLC
Cardiovascular · 127d
Cleared Mar 30, 2022
BD Trek Powered Bone Biopsy System
K213896 · KNW
Bard Peripheral Vascular
General & Plastic Surgery · 106d
Cleared Mar 30, 2022
EL CAPITAN Anterior Lumbar Interbody Fusion System
K214047 · OVD
Astura Medical
Orthopedic · 93d
Cleared Mar 30, 2022
VSP Bolus
K214093 · IXI
3D Systems
Radiology · 92d
Cleared Mar 30, 2022
Aggeris™-C
K220182 · KWQ
Clariance
Orthopedic · 68d
Cleared Mar 30, 2022
Empulse R90
K220213 · ITI
Sunrise Medical (Us), LLC
Physical Medicine · 63d
Cleared Mar 29, 2022
Reliance Cervical IBF System
K202266 · ODP
Reliance Medical Systems, LLC
Orthopedic · 595d