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
20041–20064 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 18, 2020
Catalys Precision Laser System
K200056 · OOE
Amo Manufacturng USA, LLC
Ophthalmic · 126d
Cleared May 18, 2020
V.A.C. DERMATAC Drape
K200390 · OMP
Kci USA, Inc.
General & Plastic Surgery · 90d
Cleared May 18, 2020
3D GraftRasp System
K200431 · FMF
Surgentec
General & Plastic Surgery · 87d
Cleared May 18, 2020
Natus NeuroWorks
K200878 · OMB
Natus Medical Incorporated Dba...
Neurology · 46d
Cleared May 18, 2020
syngo Ultrasound Apps Suite (sUSAS)
K201062 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared May 17, 2020
Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)
K200866 · QEP
Hologic, Inc.
Microbiology · 46d
Cleared May 15, 2020
Medtronic Commander Flex
K191745 · DXN
Medtronic Care Management Services
Cardiovascular · 319d
Cleared May 15, 2020
SonarMed AirWave Airway Monitoring System
K193058 · OQU
Sonarmed, Inc.
Anesthesiology · 196d
Cleared May 15, 2020
Biocore9 Humeral Resurfacing System
K193122 · HSD
Biocore9, LLC
Orthopedic · 185d
Cleared May 15, 2020
Pristina Serena Bright
K193334 · MUE
Ge Healthcare
Radiology · 165d
Cleared May 15, 2020
BP-BT Kiosk
K200287 · DXN
Ld Technology, LLC
Cardiovascular · 100d
Cleared May 15, 2020
AquaPulse Auxiliary Water Connector
K200479 · OCX
Ga Health Company Limited
Gastroenterology & Urology · 78d
Cleared May 15, 2020
IPL Treatment Systems
K200746 · ONF
Shanghai Apolo Medical Technology...
General & Plastic Surgery · 53d
Cleared May 15, 2020
PuriLens Plus Preservative Free Saline
K200747 · LPN
The Lifestyle Company, Inc.
Ophthalmic · 53d
Cleared May 14, 2020
Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam...
K191819 · FRO
Winner Medical Co., Ltd.
General & Plastic Surgery · 314d
Cleared May 14, 2020
KeYi Total Hip System
K191826 · LPH
Beijing Keyi Medical Device...
Orthopedic · 311d
Cleared May 14, 2020
Single Use Endoscope Valves Set
K192048 · ODC
Anrei Medical (Hangzhou) Co., Ltd.
Gastroenterology & Urology · 288d
Cleared May 14, 2020
PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB...
K192463 · FRO
Winner Medical Co., Ltd.
General & Plastic Surgery · 248d
Cleared May 14, 2020
PAL Single-Use Cannulas
K192694 · QPB
Microaire Surgical Instruments
General & Plastic Surgery · 231d
Cleared May 14, 2020
S.I.N. Dental Implant System
K193096 · DZE
S.I.N. ? Sistema DE Implante Nacional...
Dental · 189d
Cleared CT May 14, 2020
XV Lung Ventilation Analysis Software
K193293 · JAK
4Dx Limited
Radiology · 169d
Cleared May 14, 2020
VITA Ambria
K193436 · EIH
Vita Zahnfabrik GmbH H Rauter & CO
Dental · 155d
Cleared May 14, 2020
VFS1 Bipolar Electrosurgical Generator
K200169 · GEI
FHC, Inc.
General & Plastic Surgery · 112d
Cleared May 14, 2020
Support Catheter
K200317 · DQY
Qxmedical, LLC
Cardiovascular · 97d