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
7225–7248 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 2024
HOTWIRE™ RF Guidewire
K240900 · DXF
Atraverse Medical
Cardiovascular · 30d
Cleared May 01, 2024
BruxZir® Esthetic
K240882 · EIH
Prismatik Dentalcraft, Inc.
Dental · 30d
Cleared May 01, 2024
AuST Steerable Sheath
K240829 · DYB
CenterPoint Systems, LLC
Cardiovascular · 36d
Cleared May 01, 2024
VIDAS TBI (GFAP, UCH-L1)
K240279 · QAT
bioMerieux, Inc.
Immunology · 90d
Cleared May 01, 2024
MiiS Horus Bronchoscope
K234113 · EOQ
Medimaging Integrated Solution, Inc...
Ear, Nose, Throat · 126d
Cleared May 01, 2024
Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)
K233516 · HKY
Reichert, Inc.
Ophthalmic · 182d
Cleared May 01, 2024
Remex Spine Surgery Navigation System II
K233513 · OLO
Remex Medical Corp.
Orthopedic · 182d
Cleared May 01, 2024
Vial Adapter with Filter
K233284 · LHI
Hangzhou Qiantang Longyue...
General Hospital · 215d
Cleared May 01, 2024
Soft Tissue Augmentation Resorbable Matrix
K233203 · NPL
Collagen Matrix, Inc.
Dental · 216d
Cleared May 01, 2024
ORskin Blue
K232858 · GEX
Megabay S.A.
General & Plastic Surgery · 229d
Cleared May 01, 2024
Percutaneous Nephroscope System
K232370 · FGA
Karl Storz SE & CO. KG
Gastroenterology & Urology · 267d
Cleared May 01, 2024
SmarTooth
K231722 · NBL
Smartooth Co., Ltd.
Dental · 323d
Cleared Apr 30, 2024
Morpheus® Moldable
K240621 · MQV
Biogennix, LLC
Orthopedic · 56d
Cleared Apr 30, 2024
LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical...
K240156 · DSA
Physio-Control, Inc.
Cardiovascular · 102d
Cleared Apr 30, 2024
Picosecond Nd:YAG Laser System
K240118 · GEX
Smedtrum Medical Technology Co., Ltd.
General & Plastic Surgery · 105d
Cleared Apr 30, 2024
Flexset System
K233403 · GWQ
Zeto, Inc.
Neurology · 209d
Cleared Apr 30, 2024
Dental Implants and Abutments
K233231 · DZE
Ditron Dental, Ltd.
Dental · 215d
Cleared Apr 30, 2024
High Speed Air Turbine Handpiece...
K233122 · EFB
Litu Tech , Ltd.
Dental · 216d
Cleared Apr 30, 2024
Ethos Treatment Management (3.0)
K232923 · IYE
Varian Medical Systems, Inc.
Radiology · 224d
Cleared Apr 30, 2024
METICULY Patient-specific titanium maxillofacial mesh implant
K232889 · JEY
Meticuly Co., Ltd.
Dental · 225d
Cleared Apr 30, 2024
Protective Cap
K232528 · NHA
Neobiotech Co., Ltd.
Dental · 253d
Cleared Apr 29, 2024
restor3d Kinos Axiom Total Ankle System
K240591 · HSN
Restor3D, Inc.
Orthopedic · 59d
Cleared Apr 29, 2024
XTRA Autotransfusion System (with XTRA Bowl sets)
K240584 · CAC
Sorin Group Italia S.R.L.
Cardiovascular · 59d
Cleared Apr 29, 2024
DuraPro™ Oscillating System
K240568 · OLO
Globus Medical, Inc.
Orthopedic · 60d