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
6169–6192 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 2024
Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)
K240805 · HIR
Pelvital USA, Inc.
Gastroenterology & Urology · 129d
Cleared Aug 01, 2024
Infinity CentralStation Wide
K240312 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 181d
Cleared Aug 01, 2024
MammoScreen® (3)
K240301 · QDQ
Therapixel
Radiology · 182d
Cleared Aug 01, 2024
TACTIX Vector Syndesmosis System
K240035 · HTN
Vilex, LLC
Orthopedic · 210d
Cleared Aug 01, 2024
AISAP Cardio V1.0
K234141 · POK
Aisap
Radiology · 216d
Cleared Aug 01, 2024
PENTAX Medical Video Duodenoscope (ED34-i10T2s)
K233942 · FDT
Pentax of America, Inc.
Gastroenterology & Urology · 231d
Cleared Aug 01, 2024
CarboClear® X Pedicle Screw System
K233793 · NKB
CarboFix Orthopedics , Ltd.
Orthopedic · 247d
Cleared Aug 01, 2024
CardIQ Suite
K233731 · JAK
GE Medical Systems SCS
Radiology · 254d
Cleared Aug 01, 2024
DePuy Synthes Retrograde Femoral Nail Advanced System
K233696 · HSB
DePuy Synthes
Orthopedic · 258d
Cleared Aug 01, 2024
A Breathing System (ABS)
K233580 · HCC
Deepwell Dtx, Inc.
Neurology · 268d
Cleared Aug 01, 2024
Rüsch Latex Gold Foley Catheter
K232469 · EZL
Teleflexmedical, Inc.
Gastroenterology & Urology · 352d
Cleared Jul 31, 2024
NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach...
K241934 · QKZ
Anx Robotica Corp
Gastroenterology & Urology · 29d
Cleared Jul 31, 2024
EARP Nerve Cuff Electrode
K241917 · ETN
Retropsoas Technologies, LLC
Neurology · 30d
Cleared Jul 31, 2024
Silverlon® Wound Contact, Burn Contact Dressing
K241225 · FRO
Argentum Medical, LLC
General & Plastic Surgery · 90d
Cleared Jul 31, 2024
ValvuloPro Valvuloplasty Balloon Catheter
K240967 · OZT
Dongguan TT Medical, Inc.
Cardiovascular · 113d
Cleared Jul 31, 2024
SteriTite rigid reusable sterilization container with MediTray Products
K240898 · KCT
Case Medical
General Hospital · 121d
Cleared Jul 31, 2024
VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava...
K240578 · DTK
B.Braun Medical, Inc.
Cardiovascular · 152d
Cleared Jul 31, 2024
LW Narrow Implant System
K233808 · DZE
Ossvis Co., Ltd.
Dental · 244d
Cleared Jul 31, 2024
AF531 Oro-Nasal EE Leak 1 Face Mask
K233555 · BZD
Philips Respironics
Anesthesiology · 268d
Cleared Jul 31, 2024
ARCHITECT Active-B12 (Holotranscobalamin)
K233541 · CDD
Axis-Shield Diagnostics, Ltd.
Chemistry · 271d
Cleared Jul 30, 2024
WERAY
K241963 · EHD
Picopack Co., Ltd.
Radiology · 27d
Cleared Jul 30, 2024
Activmotion S
K241539 · HRS
Newclip Technics
Orthopedic · 60d
Cleared Jul 30, 2024
SmartShape™ Healing Abutment
K240531 · NHA
BioHorizons Implant Systems, Inc.
Dental · 158d
Cleared Jul 30, 2024
Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx,...
K240446 · KIF
Shiva Products
Dental · 166d