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
6433–6456 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 2024
Viral Transport Medium
K233534 · JSM
Hardy Diagnostics
Microbiology · 273d
Cleared Aug 02, 2024
MYOTouch Muscle Stimulator
K233098 · IPF
Sunmed, LLC
Physical Medicine · 311d
Cleared Aug 01, 2024
Freefix Forearm Plating System
K242055 · HRS
Skeletal Dynamics, Inc.
Orthopedic · 17d
Cleared Aug 01, 2024
EXULT Knee Replacement System
K242046 · JWH
Corentec Co., Ltd.
Orthopedic · 20d
Cleared Aug 01, 2024
KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2)
K241945 · FGB
Karl Storz SE & CO. KG
Gastroenterology & Urology · 29d
Cleared Aug 01, 2024
Logical Liner
K241690 · MEH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 50d
Cleared Aug 01, 2024
LOOP™ LED Curing Light System (CLK01)
K241238 · EBZ
Garrison Dental Solutions, LLC
Dental · 90d
Cleared Aug 01, 2024
TLAB® Transvenous Liver Biopsy System (TF-18C)
K241145 · DYB
Argon Medical Devices, Inc.
General & Plastic Surgery · 98d
Cleared Aug 01, 2024
ViroZap Indoor Air Purifier, In Duct Model 1008
K241140 · FRA
Applied Photonix, LLC
General Hospital · 99d
Cleared Aug 01, 2024
Clear Moves Aligner
K241137 · NXC
Clear Moves Aligners
Dental · 99d
Cleared Aug 01, 2024
3MP Color LCD Monitor (CL-S301)
K241105 · PGY
Jvckenwood Corporation
Radiology · 101d
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