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
17497–17520 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 2021
Vitality® Spinal Fixation System
K203507 · NKB
Zimmer Biomet Spine, Inc.
Orthopedic · 59d
Cleared Jan 28, 2021
BOSS 8F Balloon Guide Catheter
K203840 · QJP
Marblehead Medical, LLC
Neurology · 28d
Cleared Jan 27, 2021
Wrist Electronic Sphygmomanometer
K193386 · DXN
Shenzhen Changkun Technology Co., Ltd.
Cardiovascular · 418d
Cleared Jan 27, 2021
Arm Electronic Sphygmomanometer
K193387 · DXN
Shenzhen Changkun Technology Co., Ltd.
Cardiovascular · 418d
Cleared Jan 27, 2021
Vivo 45 LS
K193586 · NOU
Breas Medical AB
Anesthesiology · 401d
Cleared Jan 27, 2021
EVOS Large Fragment Plating System
K203405 · HRS
Smith & Nephew, Inc.
Orthopedic · 69d
Cleared Jan 26, 2021
Altus Spine HA Pedicle Screw System
K200922 · NKB
Altus Partners, LLC
Orthopedic · 295d
Cleared Jan 26, 2021
Airway Mobilescope
K201300 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 256d
Cleared Jan 26, 2021
BTL-899ST
K202199 · GEI
Btl
General & Plastic Surgery · 174d
Cleared Jan 26, 2021
Blood Pressure Monitor
K202934 · DXN
Bioland Technology, Ltd.
Cardiovascular · 119d
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