FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
9481–9504 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 2023
Elecsys proBNP II, Elecsys proBNP II STAT
K223637 · NBC
Roche Diagnostics
Chemistry · 228d
Cleared Jul 21, 2023
Three Way Stop Cock
K223499 · FMG
M/S Romsons International
General Hospital · 242d
Cleared Jul 21, 2023
Alkaline Phosphatase2
K223317 · CJE
Abbott Ireland Diagnostics Division
Chemistry · 266d
Cleared Jul 21, 2023
Identity Imprint Porous Total Knee Replacement System, Identity Imprint...
K223316 · MBH
Conformis, Inc.
Orthopedic · 266d
Cleared Jul 21, 2023
Cranial Navigation, Navigation Software Cranial, Navigation Software...
K223288 · HAW
Brainlab AG
Neurology · 269d
Cleared Jul 21, 2023
Firefighter™ NC Pro PTCA Balloon Catheter
K223189 · LOX
Shanghai MicroPort Medical (Group)...
Cardiovascular · 282d
Cleared Jul 21, 2023
Infrared Thermometer, Model: IR8807
K223037 · FLL
Shen Zhen Rong Feng Technology Co., Ltd.
General Hospital · 295d
Cleared Jul 21, 2023
BD Alaris™ Pump Infusion Sets
K221327 · FPA
Care Fusion
General Hospital · 441d
Cleared Jul 21, 2023
BD Alaris™ Pump Epidural Infusion Set
K221319 · PWH
Care Fusion
General Hospital · 441d
Cleared Jul 21, 2023
BD Alaris System with Guardrails Suite MX v12.1.2
K211218 · FRN
Carefusion 303, Inc.
General Hospital · 819d
Cleared Jul 20, 2023
VenaCure EVLT NeverTouch Procedure Kits
K231945 · GEX
AngioDynamics, Inc.
General & Plastic Surgery · 20d
Cleared Jul 20, 2023
CastleLoc-S Posterior Cervical Fixation System
K231840 · NKG
L & K Biomed Co., Ltd.
Orthopedic · 28d
Cleared Jul 20, 2023
QUASAR Standalone ACIF System
K231808 · OVE
GS Medical Co., Ltd.
Orthopedic · 30d
Cleared Jul 20, 2023
INERTIA® CONNEXX™ Modular Pedicle Screw System
K231799 · NKB
Nexxt Spine, LLC
Orthopedic · 30d
Cleared Jul 20, 2023
The InMode System with the Morpheus8 Applicators
K231790 · GEI
Inmode , Ltd.
General & Plastic Surgery · 30d
Cleared Jul 20, 2023
ROSA ONE Brain Application
K231103 · HAW
Medtech S.A.S
Neurology · 92d
Cleared Jul 20, 2023
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with...
K230875 · LZA
Central Medicare Sdn Bhd
General Hospital · 112d
Cleared Jul 20, 2023
Oscar 15 & Oscar 15i
K230787 · OWB
Genoray Co., Ltd.
Radiology · 120d
Cleared Jul 20, 2023
CROSSLEAD Penetration Peripheral Guide Wire
K230377 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 157d
Cleared Jul 20, 2023
uOmnispace
K230039 · QIH
Shanghai United Imaging Healthcare...
Radiology · 195d
Cleared Jul 20, 2023
AccuCheck
K223834 · IYE
Manteia Technologies Co., Ltd.
Radiology · 210d
Cleared Jul 20, 2023
IGAR System (1001.A)
K223484 · MOS
Insight Medbotics, Inc.
Radiology · 244d
Cleared Jul 20, 2023
ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation...
K223301 · OLO
Spinecraft, LLC
Orthopedic · 266d
Cleared Jul 20, 2023
Oxygen concentrator
K222920 · CAW
Zhengzhou Olive Electronic Technology...
Anesthesiology · 297d