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
25297–25320 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 2018
Pulse Oximeter
K172616 · DQA
Beijing Safe Heart Technology , Ltd.
Anesthesiology · 330d
Cleared Jul 27, 2018
RetiCapture
K173474 · HKI
Ilooda Co,., Ltd.
Ophthalmic · 260d
Cleared Jul 27, 2018
Voutia™
K173808 · LFD
Jeffrey Ward Cash, Dds
Dental · 224d
Cleared Jul 27, 2018
OsteoFab Patient Specific Cranial Device
K180064 · GXN
Oxford Performance Materials, Inc.
Neurology · 199d
Cleared Jul 27, 2018
Ti 3Z Interbody System
K180076 · MAX
Zavation Medical Products, LLC
Orthopedic · 198d
Cleared Jul 27, 2018
Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal...
K180485 · FJS
Covidien, LLC
Gastroenterology & Urology · 154d
Cleared Jul 27, 2018
Corelink Foundation 3D Anterior Lumbar System
K180556 · MAX
Corelink, LLC
Orthopedic · 148d
Cleared Jul 27, 2018
Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices
K180580 · KTT
Surgical Instrument Service and...
Orthopedic · 144d
Cleared Jul 27, 2018
Macroduct Advanced Model 3710
K180627 · KTB
Elitechgroup, Inc.
Physical Medicine · 140d
Cleared Jul 27, 2018
Panther Fusion GBS Assay
K181156 · NJR
Diagenode
Microbiology · 87d
Cleared Jul 27, 2018
OIC Intramedullary Nail System
K181184 · HSB
The Orthopaedic Implant Company
Orthopedic · 85d
Cleared Jul 27, 2018
Universal Cannula Seal (5-12 mm)
K181395 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 59d
Cleared Jul 27, 2018
RCT800
K181452 · OAS
Ray Co., Ltd.
Radiology · 56d
Cleared Jul 27, 2018
EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic...
K181485 · IYN
Philips Ultrasound, Inc.
Radiology · 51d
Cleared Jul 27, 2018
Stowe Pedicle Screw System
K181554 · NKB
Black Box Medical
Orthopedic · 44d
Cleared Jul 27, 2018
FlowTriever Retrieval/Aspiration System
K181694 · QEW
Inari Medical
Cardiovascular · 30d
Cleared Jul 27, 2018
FUJIFILM Ultrasonic Endoscope
K181763 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 24d
Cleared Jul 26, 2018
Vios Central Station Monitor Software, Vios Central Server Software
K173107 · DXJ
Vios Medical, Inc.
Cardiovascular · 300d
Cleared Jul 26, 2018
Arthrex FibuLock Nail
K173656 · HSB
Arthrex, Inc.
Orthopedic · 239d
Cleared Jul 26, 2018
Saniclave 250
K180272 · FLE
Revolutionary Science
General Hospital · 176d
Cleared Jul 26, 2018
Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter,...
K180958 · PPN
Shockwave Medical, Inc.
Cardiovascular · 105d
Cleared Jul 26, 2018
PROLENE (Polypropylene) 3D Patch
K181268 · FTL
Ethicon, Inc.
General & Plastic Surgery · 73d
Cleared Jul 26, 2018
RxSight Insertion Device
K181401 · MSS
Rxsight, Inc.
Ophthalmic · 58d
Cleared Jul 26, 2018
eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas...
K181579 · HQD
E&E Optics, Inc.
Ophthalmic · 41d