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
24913–24936 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 2018
OralTox Oral fluid Drug Test
K181305 · DJC
Premier Biotech, Inc.
Toxicology · 126d
Cleared Sep 20, 2018
Aequalis Flex Revive Shoulder System
K181420 · KWS
Tornier, Inc.
Orthopedic · 112d
Cleared Sep 20, 2018
Medline Patient Cables and Lead Wires
K181726 · DSA
Medline Industries, Inc.
Cardiovascular · 83d
Cleared Sep 20, 2018
LOGIQ P9
K181783 · IYN
Ge Healthcare
Radiology · 79d
Cleared Sep 20, 2018
Chiral Surgical Pedicle Screw System
K181995 · NKB
Chiral Surgical
Orthopedic · 56d
Cleared Sep 20, 2018
NICO Myriad
K182340 · GEI
Nico Corporation
Obstetrics & Gynecology · 23d
Cleared Sep 19, 2018
CSM Submerged3-L Implant System
K173141 · DZE
Csm Implant
Dental · 355d
Cleared Sep 19, 2018
FORTIFY Corpectomy Spacers
K173982 · MQP
Globus Medical, Inc.
Orthopedic · 264d
Cleared Sep 19, 2018
Bard Vertus Foley Catheter
K180781 · EZL
C.R. Bard, Inc.
Gastroenterology & Urology · 177d
Cleared Sep 19, 2018
IHM Technology Bandage
K180893 · QSY
Protege Biomedical
General & Plastic Surgery · 167d
Cleared Sep 19, 2018
Magnetic Surgical System
K180894 · PNL
Levita Magnetics International Corp
General & Plastic Surgery · 167d
Cleared Sep 19, 2018
Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit
K180981 · GZB
Stimwave Technologies Incorporated
Neurology · 159d
Cleared Sep 19, 2018
TirboLOX-C Cervical IBFD
K181229 · ODP
Captiva Spine, Inc.
Orthopedic · 133d
Cleared Sep 19, 2018
T2 STRATOSPHERE™ Expandable Corpectomy System
K181328 · MQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 124d
Cleared Sep 19, 2018
Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact...
K181349 · LPL
Visco Vision, Inc.
Ophthalmic · 121d
Cleared Sep 19, 2018
Ortoma Treatment Solution - OTS
K181449 · OLO
Ortoma AB
Orthopedic · 110d
Cleared Sep 19, 2018
Beurer IPL 8500 device/ IPL VelvetSkin Pro
K181734 · OHT
Home Well Trading, Ltd.
General & Plastic Surgery · 79d
Cleared Sep 19, 2018
Scope Antifogging System
K182080 · GCJ
Xodus Medical, Inc.
General & Plastic Surgery · 48d
Cleared Sep 19, 2018
Oh'Care Lite Smart Blood Glucose Monitoring System
K182286 · NBW
Osang Healthcare Co. , Ltd.
Chemistry · 27d
Cleared Sep 18, 2018
Tandry Locking Plate System
K171904 · HRS
Microware Precision Co., Ltd.
Orthopedic · 449d
Cleared Sep 18, 2018
MAC VU360 Resting ECG Analysis System
K173830 · DPS
Ge Medical Systems Information...
Cardiovascular · 274d
Cleared Sep 18, 2018
Elecsys FT4 III
K181233 · CEC
Roche Diagnostics
Chemistry · 132d
Cleared Sep 18, 2018
Caprolon
K181320 · GAM
Resorba Medical GmbH
General & Plastic Surgery · 123d
Cleared Sep 18, 2018
Sypher Spacer System
K181337 · MAX
Biogennix, LLC
Orthopedic · 120d