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
19897–19920 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 2020
Medacta Shoulder System
K192967 · PHX
Medacta International S.A.
Orthopedic · 154d
Cleared Mar 25, 2020
MIS CONNECT Conical Connection System
K193078 · NHA
Dentsply Sirona
Dental · 141d
Cleared Mar 25, 2020
Aluna
K193311 · BZH
Knox Medical Diagnostics, Inc.
Anesthesiology · 117d
Cleared Mar 25, 2020
IPL + Diode Laser Machine
K193328 · ONF
Beijing Globalipl Development Co., Ltd.
General & Plastic Surgery · 114d
Cleared Mar 25, 2020
NuVasive 3DP Interfixated ALIF System
K193593 · OVD
Nu Vasive, Incorporated
Orthopedic · 93d
Cleared Mar 25, 2020
FINE Osteotomy around the knee
K193614 · HRS
Bodycad Laboratories, Inc.
Orthopedic · 90d
Cleared Mar 25, 2020
NorthStar™ OCT Spinal System
K193615 · NKG
SeaSpine Orthopedics Corporation
Orthopedic · 90d
Cleared Mar 25, 2020
Cry-Ac®, Cry-Ac-3®, Cry-Baby
K193619 · GEH
Brymill Cryogenic Systems
General & Plastic Surgery · 90d
Cleared Mar 25, 2020
Disposable NIBP Cuff
K193629 · DXQ
Shenzhen Changke Connect Electronics...
Cardiovascular · 90d
Cleared Mar 25, 2020
LightWalker Laser System Family
K193661 · GEX
Fotona D.O.O.
General & Plastic Surgery · 86d
Cleared Mar 25, 2020
Shapiro MD model laser 272
K193667 · OAP
Conversion Labs, Pr, LLC
General & Plastic Surgery · 85d
Cleared Mar 25, 2020
TempSure System
K200241 · PBX
Cynosure, LLC
General & Plastic Surgery · 54d
Cleared Mar 25, 2020
syngo.CT Cardiac Planning
K200515 · JAK
Siemens Medical Soultions USA, Inc.
Radiology · 23d
Cleared Mar 24, 2020
RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0...
K193100 · NKB
OrthoPediatrics Corp.
Orthopedic · 137d
Cleared Mar 24, 2020
Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch
K193145 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 132d
Cleared Mar 24, 2020
Sherlock
K193335 · NHA
Open Implants, LLC
Dental · 113d
Cleared Mar 24, 2020
PlasmaBlade X 3.0S LIGHT
K193579 · GEI
Medtronic Navigation
General & Plastic Surgery · 92d
Cleared Mar 24, 2020
Persona Personalized Knee System
K200209 · JWH
Zimmer, Inc.
Orthopedic · 56d
Cleared Mar 24, 2020
SEA-LINK Anterior Cervical Plate System
K200224 · KWQ
Indius Medical Technologies Pvt. , Ltd.
Orthopedic · 55d
Cleared Mar 24, 2020
FloPatch (FP120)
K200337 · DPW
Flosonics Medical (R/A 1929803...
Cardiovascular · 42d
Cleared Mar 23, 2020
Somryst
K191716 · QVO
Pear Therapeutics, Inc.
Neurology · 271d
Cleared Mar 23, 2020
MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon...
K191763 · LPL
CooperVision, Inc.
Ophthalmic · 266d
Cleared Mar 23, 2020
CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal...
K191788 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 264d
Cleared Mar 23, 2020
HepaShield Bacterial Viral Breathing System Filter
K191909 · CAH
Flexicare Medical Limited.
General Hospital · 250d