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
29497–29520 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 19, 2017
Medline Waste Station
K160660 · DQO
Medline Industries, Inc.
Cardiovascular · 317d
Cleared Jan 19, 2017
Cranial PSI
K161090 · GXN
Ossdsign AB
Neurology · 276d
Cleared Jan 19, 2017
da Vinci Xi Surgical System
K161178 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 268d
Cleared Jan 19, 2017
meso-relle (AAL34, AAL36, AM30G)
K161255 · FMI
Biotekne Srl
General Hospital · 261d
Cleared Jan 19, 2017
Anatomic Total Knee System
K161414 · JWH
Amplitude
Orthopedic · 241d
Cleared Jan 19, 2017
Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation...
K161418 · OMP
Cardinalhealth
General & Plastic Surgery · 241d
Cleared Jan 19, 2017
Juno VPAP ST-A
K161492 · MNS
Resmed, Ltd.
Anesthesiology · 232d
Cleared Jan 19, 2017
GMI Frontier Dental Implant System
K161593 · DZE
Ilerimplant S.L
Dental · 224d
Cleared Jan 19, 2017
Polysmith Sleep System, Model NTI7593
K161650 · OLV
Neurotronics, Inc.
Neurology · 218d
Cleared Jan 19, 2017
Fever Scout™ Continuous Monitoring thermometer
K162137 · FLL
VivaLNK, Inc.
General Hospital · 171d
Cleared Jan 19, 2017
Comfort Flo Humidification System
K162242 · BTT
Teleflexmedical, Inc.
Anesthesiology · 162d
Cleared Jan 19, 2017
Titan 3 Low Speed Angle Attachments
K162397 · EGS
Dentalez, Inc.
Dental · 146d
Cleared Jan 19, 2017
Atellica CH Magnesium (Mg)
K162399 · JGJ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 146d
Cleared Jan 19, 2017
UniStrip1 Generic Blood Glucose Test Strips
K162430 · NBW
Ok Biotech Co., Ltd.
Chemistry · 141d
Cleared Jan 19, 2017
NC Gallant PTCA Catheter
K162434 · LOX
Medinol, Ltd.
Cardiovascular · 141d
Cleared Jan 19, 2017
TrueBeam-TrueBeam STx-Edge
K162472 · IYE
Varian Medical Systems, Inc.
Radiology · 135d
Cleared Jan 19, 2017
JAZZ FRAME SYSTEM
K162764 · NKB
Implanet, S.A.
Orthopedic · 111d
Cleared Jan 19, 2017
Ranfac Fat Aspiration Cannula
K162932 · MUU
Ranfac, Corp.
General & Plastic Surgery · 91d
Cleared Jan 19, 2017
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
K163069 · NEZ
Olympus Medical Systems Corp.
Gastroenterology & Urology · 78d
Cleared Jan 19, 2017
Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series
K163113 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 73d
Cleared Jan 19, 2017
LEDEX WL070+
K163605 · EBZ
Dentmate Technology Co. , Ltd.
Dental · 29d
Cleared Jan 19, 2017
Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD...
K163620 · JOW
Covidien
Cardiovascular · 28d
Cleared Jan 18, 2017
Taps for Resorbable Screws
K153587 · HBG
Synthes USA Products, LLC
Neurology · 399d
Cleared Jan 18, 2017
STIMPOD NMS460 Nerve Stimulator
K161091 · GZJ
Xavant Technology (Pty), Ltd.
Neurology · 275d