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
18097–18120 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 2021
IBM iConnect Access
K203104 · LLZ
Merge Healthcare Incorporated
Radiology · 104d
Cleared Jan 26, 2021
M.U.S.T. Pedicle Screw Extension and Long Tab Implants
K203482 · NKB
Medacta International S.A.
Orthopedic · 60d
Cleared Jan 26, 2021
VASOBand Vascular Compression Device
K203803 · DXC
Vasoinnovations, Inc.
Cardiovascular · 29d
Cleared Jan 26, 2021
General Radiography CXDI-CS01
K203849 · MQB
Canon, Inc.
Radiology · 26d
Cleared Jan 25, 2021
Pulse Oximeter
K201468 · DQA
Shenzhen Creative Industry Co., Ltd.
Anesthesiology · 237d
Cleared Jan 25, 2021
Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory
K202742 · IYN
Viasonix , Ltd.
Radiology · 129d
Cleared Jan 25, 2021
Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp,...
K202856 · IYN
Edan Instruments, Inc.
Radiology · 119d
Cleared Jan 25, 2021
VERTACONNECT TLIF Cage
K203327 · MAX
Signus Medizintechnik
Orthopedic · 74d
Cleared Jan 25, 2021
BD Hypodermic Syringe
K203453 · FMF
Becton, Dickinson and Company
General Hospital · 63d
Cleared Jan 25, 2021
Non-Contact Forehead Thermometer (Models UT306H & UT308H)
K203747 · FLL
Uni-Trend Technology (China) Co., Ltd.
General Hospital · 34d
Cleared Jan 25, 2021
vatech A9 (Model : PHT-30CSS)
K203797 · OAS
VATECH Co., Ltd.
Radiology · 28d
Cleared Jan 23, 2021
Cytoplast Titanium-Reinforced PTFE Membranes
K201187 · NPK
Osteogenics Biomedical, Inc.
Dental · 267d
Cleared Jan 23, 2021
Patient Monitor
K202336 · MHX
Edan Instruments, Inc.
Cardiovascular · 159d
Cleared Jan 22, 2021
MIIN
K193266 · GEX
Medico USA, Inc.
General & Plastic Surgery · 423d
Cleared Jan 22, 2021
Piccolo Medical SmartPICC System
K200037 · LJS
Piccolo Medical, Inc.
Cardiovascular · 380d
Cleared Jan 22, 2021
ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue...
K201066 · GEI
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 275d
Cleared Jan 22, 2021
Simply Iconic Implants
K201553 · DZE
Implant Direct Sybron Manufacturing, LLC
Dental · 226d
Cleared Jan 22, 2021
ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue...
K201696 · GEI
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 214d
Cleared Jan 22, 2021
NuFace Trinity Plus Device
K201782 · NFO
Carol Cole Company Dba Nuface
Neurology · 206d
Cleared Jan 22, 2021
VirtueRF
K202415 · GEI
ShenB Co., Ltd.
General & Plastic Surgery · 151d
Cleared Jan 22, 2021
ClearPoint Array System
K202575 · HAW
ClearPoint Neuro, Inc.
Neurology · 140d
Cleared Jan 22, 2021
Surgical Mask
K202640 · FXX
Jiangsu Medpure Biological Technology...
General Hospital · 133d
Cleared Jan 22, 2021
SPRINT PNS System
K202660 · NHI
Spr Therapeutics, Inc.
Neurology · 130d
Cleared Jan 22, 2021
BRIUS Clear Aligners
K202792 · NXC
Brius Technologies, Inc.
Dental · 122d