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
10177–10200 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 04, 2023
Pollogen STOP U Model UXV Device
K220322 · PAY
Pollogen, Ltd.
General & Plastic Surgery · 455d
Cleared May 04, 2023
Revitalair 430+
K220290 · CBF
Us Hyperbaric Network
Anesthesiology · 457d
Cleared May 04, 2023
BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application,...
K213280 · QQY
Bd Kiestra B.V.
Microbiology · 580d
Cleared May 04, 2023
Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit,...
K203245 · MMW
Nucleix , Ltd.
Medical Genetics · 912d
Cleared May 03, 2023
BFlex™ 2 Slim 3.8 Single-Use Bronchoscope
K230948 · EOQ
Verathon Medical (Canada) Ulc
Ear, Nose, Throat · 29d
Cleared May 03, 2023
ARIX Humerus System
K230938 · HRS
Jeil Medical Corporation
Orthopedic · 30d
Cleared May 03, 2023
ViewFlex™ Eco Reprocessed ICE Catheter
K230934 · OWQ
Abbott Medical
Cardiovascular · 30d
Cleared May 03, 2023
PEEK RCI Screw
K230655 · MBI
Signature Orthopaedics Pty, Ltd.
Orthopedic · 55d
Cleared May 03, 2023
Dentis I-FIX Abutment
K230203 · NHA
Dentis Co., Ltd.
Dental · 98d
Cleared May 03, 2023
Apollo Knotless Suture Anchor
K230123 · MBI
Maruho Medical
Orthopedic · 106d
Cleared May 03, 2023
FloPatch FP120
K223843 · DPW
Flosonics Medical
Cardiovascular · 132d
Cleared May 03, 2023
Epione
K223758 · JAK
Quantum Surgical Sas
Radiology · 139d
Cleared May 03, 2023
Sphincterotome
K222421 · KNS
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 265d
Cleared May 03, 2023
MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System
K212743 · JSM
Medschenker, Inc.
Microbiology · 611d
Cleared May 02, 2023
SIS System
K230977 · QIH
Surgical Information Sciences, Inc.
Radiology · 27d
Cleared May 02, 2023
TriSalus TriNav® LV Infusion System
K230957 · KRA
Trisalus Life Sciences
Cardiovascular · 28d
Cleared May 02, 2023
Artix BG
K230912 · QEW
Inari Medical
Cardiovascular · 32d
Cleared May 02, 2023
CoreLink Navigation Instruments
K230880 · OLO
Corelink, LLC
Orthopedic · 33d
Cleared May 02, 2023
Cortium™
K230614 · NKG
Ulrich Medical USA
Orthopedic · 57d
Cleared May 02, 2023
AcQMap® High Resolution Imaging and Mapping System
K230606 · DQK
Acutus Medical, Inc.
Cardiovascular · 60d
Cleared May 02, 2023
Samsung ECG Monitor Application with Irregular Heart Rhythm Notification
K230292 · QDA
Samsung Electronics Co., Ltd.
Cardiovascular · 89d
Cleared May 02, 2023
3D Anatomic Model
K230119 · LLZ
Ricoh USA, Inc.
Radiology · 105d
Cleared May 02, 2023
NuEra Tight RF Model APMD145.M70-US
K223907 · PBX
Bios S.R.L.
General & Plastic Surgery · 125d
Cleared May 02, 2023
PressON Spinal Fixation System
K223529 · NKB
Nexus Spine, LLC
Orthopedic · 160d