FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
20089–20112 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 11, 2020
Critical Alert CommonPath Enterprise
K193043 · MSX
Critical Alert
Cardiovascular · 193d
Cleared May 11, 2020
PuraDERM Gel
K193085 · FRO
3-D Matrix, Inc.
General & Plastic Surgery · 188d
Cleared May 11, 2020
Biograph mMR with syngo MR E11P-AP01 system software
K200213 · OUO
Siemens Medical Solutions USA, Inc.
Radiology · 104d
Cleared May 11, 2020
Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)
K200290 · MQV
SeaSpine Orthopedics Corporation
Orthopedic · 96d
Cleared May 11, 2020
ArtiSential Laparoscopic Instrument-Electrodes
K200501 · GEI
Livsmed, Inc.
General & Plastic Surgery · 73d
Cleared May 11, 2020
Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11
K200841 · GEI
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 41d
Cleared May 09, 2020
Dermalux Tri-Wave MD
K200659 · GEX
Aesthetic Technology, Ltd.
General & Plastic Surgery · 58d
Cleared May 08, 2020
Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate
K192209 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 268d
Cleared May 08, 2020
Custom Legacy and Custom InterActive Titanium Abutments
K192218 · NHA
Implant Direct Sybron Manufacturing, LLC
Dental · 267d
Cleared May 08, 2020
PRECICE Bone Transport System
K193016 · HSB
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 192d
Cleared May 08, 2020
Precice® Screws
K193617 · HSB
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 134d
Cleared May 08, 2020
Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)
K200348 · PLV
Neocis, Inc.
Dental · 86d
Cleared May 08, 2020
ALTAPORE SHAPE
K200640 · MQV
Baxter Healthcare Corporation
Orthopedic · 58d
Cleared May 08, 2020
Mazor X
K200935 · OLO
Mazor Robotics , Ltd.
Orthopedic · 30d
Cleared May 08, 2020
Ventricular Catheter
K200950 · JXG
Aesculap, Inc.
Neurology · 29d
Cleared May 08, 2020
Treace Medical Concepts (TMC) Plating System
K200961 · HRS
Treace Medical Concepts, Inc.
Orthopedic · 28d
Cleared May 08, 2020
Sonosite PX Ultrasound System
K200964 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 28d
Cleared May 07, 2020
Actreen Hi-Lite Intermittent Urinary Catheters
K192577 · GBM
B.Braun Medical, Inc.
Gastroenterology & Urology · 231d
Cleared May 07, 2020
ZAGA Zygomatic System
K192651 · DZE
Southern Implants (Pty), Ltd.
Dental · 226d
Cleared May 07, 2020
Nuvo Nano Portable Oxygen Concentrator
K192693 · CAW
Nidek Medical Products, Inc.
Anesthesiology · 224d
Cleared May 07, 2020
Chemfort CSTD
K192866 · ONB
Simplivia Healthcare , Ltd.
General Hospital · 213d
Cleared May 07, 2020
Patient Monitor
K192972 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 196d
Cleared May 07, 2020
EZER, Portable X-ray System
K193535 · IZL
Livermoretech, Inc.
Radiology · 139d
Cleared May 07, 2020
LiteSaber Wire Torque Assist Device
K200120 · DQX
Vesatek, LLC
Cardiovascular · 107d