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
9313–9336 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 2023
Medline UNITE® REFLEX® Nitinol Staple System
K231885 · JDR
Medline Industries, LP
Orthopedic · 43d
Cleared Aug 09, 2023
VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack
K231525 · NIG
Ortho-Clinical Diagnostics
Immunology · 75d
Cleared Aug 09, 2023
Intense Pulsed Light System
K231394 · ONF
Smedtrum Medical Technology Co., Ltd.
General & Plastic Surgery · 86d
Cleared Aug 09, 2023
Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles,...
K231376 · MBI
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Aug 09, 2023
Conductive Silicone Rubber Electrode
K231167 · GXY
Guangzhou Xinbo Electronic Co., Ltd.
Neurology · 106d
Cleared Aug 09, 2023
Conductive carbon film electrode
K231164 · GXY
Guangzhou Xinbo Electronic Co., Ltd.
Neurology · 106d
Cleared Aug 09, 2023
Zimmer® Natural Nail® System Cephalomedullary Nails
K231114 · HSB
Zimmer Switzerland Manufacturing GmbH
Orthopedic · 112d
Cleared Aug 09, 2023
Polyisoprene Surgical Gloves
K230304 · KGO
Puyang Linshi Medical Supplies Co., Ltd.
General Hospital · 187d
Cleared Aug 09, 2023
Air Smart Extra Spirometer
K222443 · BZG
Feellife Health, Inc.
Anesthesiology · 362d
Cleared Aug 08, 2023
Efai Pacs Picture Archiving and Communication System Pro
K232100 · LLZ
Ever Fortune.Ai, Co., Ltd.
Radiology · 25d
Cleared Aug 08, 2023
Ceribell Instant EEG Headband
K232052 · GXY
Ceribell, Inc.
Neurology · 29d
Cleared Aug 08, 2023
Disposable Medical Examination Nitrile Gloves
K232008 · LZA
Raxwell Industrial, LLC
General Hospital · 33d
Cleared Aug 08, 2023
Arthrex TightRope II
K231857 · MBI
Arthrex, Inc.
Orthopedic · 46d
Cleared Aug 08, 2023
Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter
K230620 · DQO
Gentuity, LLC
Cardiovascular · 155d
Cleared Aug 08, 2023
Visual-ICE Cryoablation System
K230551 · GEH
Boston Scientific Corporation
Orthopedic · 161d
Cleared Aug 08, 2023
LW Implant System
K223924 · DZE
Ossvis Co., Ltd.
Dental · 221d
Cleared Aug 08, 2023
Rubicon™ Control Support Catheter (H749394323506A1)
K223633 · DQY
Boston Scientific Corporation
Cardiovascular · 246d
Cleared Aug 08, 2023
Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
K222439 · LEH
Siemens Healthcare Diagnostics, Inc.
Toxicology · 361d
Cleared Aug 08, 2023
Protective Gown AAMI Level 4
K222128 · QPC
Kenpax International Limited
General Hospital · 386d
Cleared Aug 07, 2023
PRO-LITE Sterilization Tray
K231501 · KCT
STERIS Corporation
General Hospital · 75d
Cleared Aug 07, 2023
Vis-U-All Low Temperature Sterilization Pouches
K231500 · FRG
STERIS Corporation
General Hospital · 75d
Cleared Aug 07, 2023
Celerity 20 HP Biological Indicator
K231490 · FRC
STERIS Corporation
General Hospital · 76d
Cleared Aug 07, 2023
Celerity™ HP Chemical Indicator
K231488 · JOJ
Steris
General Hospital · 76d
Cleared Aug 07, 2023
LineSider® Spinal System
K231098 · NKB
Integrity Implants, Inc.
Orthopedic · 111d