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
28681–28704 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 2017
SpiralTech Dental Implant System
K170372 · DZE
Spiraltech Superior Dental Implants,...
Dental · 143d
Cleared Jun 30, 2017
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...
K170794 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 106d
Cleared Jun 30, 2017
FIBERGRAFT BG Matrix Bone Graft Substitute
K171284 · MQV
Prosidyan, Inc.
Orthopedic · 60d
Cleared Jun 30, 2017
Smart External Drain (SED) System
K171586 · JXG
Aqueduct Critical Care, Inc.
Neurology · 30d
Cleared Jun 30, 2017
ACUITY Pro Lead Delivery System
K171612 · DQY
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Jun 30, 2017
Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall...
K171621 · MHX
Welch Allyn, Inc.
Cardiovascular · 28d
Cleared Jun 30, 2017
Infinity-Lock 3, Infinity-Lock 5
K171680 · GAT
Xiros, Ltd.
General & Plastic Surgery · 24d
Cleared Jun 29, 2017
SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL
K161710 · MAX
Spinal Analytics & Geometrical Impant...
Orthopedic · 373d
Cleared Jun 29, 2017
ADAMS A1c HA-8180V, CALIBRATOR 80
K162822 · PDJ
Arkray Factory, Inc.
Chemistry · 265d
Cleared Jun 29, 2017
PHA S1 Spinal System
K163011 · NKB
Phamedica, Inc.
Orthopedic · 244d
Cleared Jun 29, 2017
Parietene DS Composite Mesh
K163212 · FTL
Sofradim Production
General & Plastic Surgery · 225d
Cleared Jun 29, 2017
SMR Hybrid Glenoid System
K163397 · MBF
Lima Corporate S.P.A.
Orthopedic · 206d
Cleared Jun 29, 2017
Vessel Dilator
K163524 · DWP
Fetzer Medical GmbH & Co. KG
Cardiovascular · 196d
Cleared Jun 29, 2017
Firebow Wire Torque Assist Device
K170684 · DQX
Vesatek, LLC
Cardiovascular · 114d
Cleared Jun 29, 2017
Admira Fusion x-base
K170896 · EBF
Voco GmbH
Dental · 94d
Cleared Jun 29, 2017
Rickettsia Real-time PCR Assay
K170940 · PVQ
Centers For Disease Control and...
Microbiology · 91d
Cleared Jun 29, 2017
BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set
K171514 · MXD
Biotronik, Inc.
Cardiovascular · 36d
Cleared Jun 29, 2017
Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap
K171533 · FRG
Ahlstrom Nonwovens, LLC
General Hospital · 35d
Cleared Jun 28, 2017
Livia
K163153 · NUH
Lifecare , Ltd.
Neurology · 230d
Cleared Jun 28, 2017
Delta III Lithotripter
K170122 · LNS
Dornier Medtech America
Gastroenterology & Urology · 166d
Cleared Jun 28, 2017
SupraSDRM Biodegradable Matrix Wound Dressing
K170213 · QSZ
Polymedics Innovations, GmbH
General & Plastic Surgery · 155d
Cleared Jun 28, 2017
Unison-C Anterior Cervical Fixation System
K170830 · OVE
Pioneer Surgical Technology, Inc....
Orthopedic · 100d
Cleared Jun 28, 2017
TULA Tube Delivery System
K171239 · ETD
Tusker Medical
Ear, Nose, Throat · 62d
Cleared Jun 27, 2017
Cannulated Screws Neoortho
K162874 · HWC
Neoortho Produtos Ortopedicos S/A
Orthopedic · 257d