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
10441–10464 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 04, 2023
swiftPro System
K222388 · NEY
Emblation , Ltd.
General & Plastic Surgery · 269d
Cleared May 04, 2023
Ceramic Brackets Orthometric
K222847 · NJM
Orthometric - Industria E Comercio DE...
Dental · 225d
Cleared May 04, 2023
ProLift Micro Expandable Spacer System
K223430 · MAX
Life Spine, Inc.
Orthopedic · 171d
Cleared May 04, 2023
SimPro™ Now, GentleCath™ Hydrophilic
K223756 · EZD
Dentsply Sirona
Gastroenterology & Urology · 140d
Cleared May 04, 2023
Lumify Diagnostic Ultrasound System
K223771 · IYN
Philips Ultrasound
Radiology · 139d
Cleared May 04, 2023
Agnes
K223805 · GEI
Agnes Medical Co., Ltd.
General & Plastic Surgery · 136d
Cleared May 04, 2023
Auto Segmentation
K230082 · QKB
Ge Medical Systems, LLC
Radiology · 113d
Cleared May 04, 2023
Orchid Safety Release Valve
K230266 · QOI
Linear Health Sciences, LLC
General Hospital · 93d
Cleared May 04, 2023
Lucas Plus
K230340 · GEX
Amt Engineering Co., Ltd.
General & Plastic Surgery · 86d
Cleared May 04, 2023
SOZO Pro
K230530 · OBH
ImpediMed Limited
Gastroenterology & Urology · 66d
Cleared May 04, 2023
SOZO Pro
K230531 · QJB
ImpediMed Limited
Gastroenterology & Urology · 66d
Cleared May 04, 2023
Hubly Electric Drill (H100)
K230619 · HBE
Hubly, Inc.
Neurology · 59d
Cleared May 04, 2023
Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System,...
K230653 · JWH
Smith & Nephew, Inc.
Orthopedic · 56d
Cleared May 04, 2023
DLP™ Silicone Coronary Artery Ostial Cannulae
K230960 · DWF
Medtronic, Inc.
Cardiovascular · 29d
Cleared May 04, 2023
Alinity i STAT High Sensitivity Troponin-I
K230994 · MMI
Abbott Laboratories Diagnostics Division
Chemistry · 27d
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 03, 2023
Sphincterotome
K222421 · KNS
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 265d
Cleared May 03, 2023
Epione
K223758 · JAK
Quantum Surgical Sas
Radiology · 139d
Cleared May 03, 2023
FloPatch FP120
K223843 · DPW
Flosonics Medical
Cardiovascular · 132d
Cleared May 03, 2023
Apollo Knotless Suture Anchor
K230123 · MBI
Maruho Medical
Orthopedic · 106d
Cleared May 03, 2023
Dentis I-FIX Abutment
K230203 · NHA
Dentis Co., Ltd.
Dental · 98d
Cleared May 03, 2023
PEEK RCI Screw
K230655 · MBI
Signature Orthopaedics Pty, Ltd.
Orthopedic · 55d
Cleared May 03, 2023
ViewFlex™ Eco Reprocessed ICE Catheter
K230934 · OWQ
Abbott Medical
Cardiovascular · 30d
Cleared May 03, 2023
ARIX Humerus System
K230938 · HRS
Jeil Medical Corporation
Orthopedic · 30d