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
28105–28128 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 27, 2017
Pinpoint GT Needles
K163216 · BSP
C.R. Bard, Inc.
Anesthesiology · 223d
Cleared Jun 27, 2017
Stellar LEAP
K163432 · IOR
Pdg Product Design Group, Inc.
Physical Medicine · 202d
Cleared Jun 27, 2017
Tranquil Interbody System
K170297 · MAX
Nexus Spine, LLC
Orthopedic · 147d
Cleared Jun 27, 2017
OWL RF INSULATED CANNULAE
K170708 · GXI
Diros Technology, Inc.
Neurology · 111d
Cleared Jun 27, 2017
Powder-Free Clear Vinyl Patient Examination Gloves
K170735 · LYZ
Zibo Yue Fan Medical Products Co, Ltd.
General Hospital · 109d
Cleared Jun 27, 2017
Halcyon
K170817 · IYE
Varian Medical Systems, Inc.
Radiology · 99d
Cleared Jun 27, 2017
Contact Lens Case Round Glasses
K171163 · LRX
Fiftytwoways, Ltd.
Ophthalmic · 68d
Cleared Jun 27, 2017
RayStation
K171536 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 33d
Cleared Jun 27, 2017
Distal Elbow Plating System
K171590 · HRS
Skeletal Dynamics, LLC
Orthopedic · 27d
Cleared Jun 27, 2017
Smith & Nephew 25 Fluid Management System
K171794 · HRX
Smith & Nephew, Inc.
Orthopedic · 11d
Cleared Jun 26, 2017
SpringTMS
K162797 · OKP
Eneura, Inc.
Neurology · 265d
Cleared Jun 26, 2017
Swedge™ Pedicle Screw Fixation System
K170045 · NKB
Spinal Resources, Inc.
Orthopedic · 172d
Cleared Jun 26, 2017
LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100...
K170416 · DJR
Lin-Zhi International, Inc.
Toxicology · 136d
Cleared Jun 26, 2017
PROCOTYL® PRIME Acetabular Cup System
K170444 · LPH
Microport Orthopedics, Inc.
Orthopedic · 132d