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
32929–32952 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 18, 2015
AN85/AN86 EO Indicators
K150644 · JOJ
Andersen Sterilizers, Inc.
General Hospital · 251d
Cleared Nov 18, 2015
EOGas 4 Ethylene Oxide Gas Sterilizer
K150646 · FLF
Andersen Sterilizers, Inc.
General Hospital · 251d
Cleared Nov 18, 2015
WASTON General Spinal System
K150684 · MNI
Changzhou Waston Medical Appliance...
Orthopedic · 246d
Cleared Nov 18, 2015
R350 guidewire
K151234 · DQX
Vascular Solutions, Inc.
Cardiovascular · 194d
Cleared Nov 18, 2015
Andersen EOGas 4 SteriTest
K151585 · FRC
Andersen Sterilizers, Inc.
General Hospital · 160d
Cleared Nov 18, 2015
Tyvek Sterilization Pouches with Chevron Seal
K152058 · FRG
Andersen Sterilizers, Inc.
General Hospital · 117d
Cleared Nov 18, 2015
Clickfine AutoProtect Pen Needle
K152514 · FMI
Ypsomed AG
General Hospital · 77d
Cleared Nov 18, 2015
8 CH Knee SPEEDER
K152695 · MOS
Quality Electrodynamics, LLC
Radiology · 58d
Cleared Nov 18, 2015
Venue 50
K152758 · IYN
GE Medical Systems Ultrasound and...
Radiology · 55d
Cleared Nov 18, 2015
Philips IntelliSpace Cardiovascular
K153022 · LLZ
Philips Medical Systems Nethrlands BV
Radiology · 34d
Cleared Nov 17, 2015
PULLUP® Adjustable Juxtacortical Fixation Device
K151004 · MBI
Sbm Sciences For Bio Materials
Orthopedic · 216d
Cleared Nov 17, 2015
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K151682 · LYZ
Daxwell, LLC
General Hospital · 148d
Cleared Nov 17, 2015
Nanova Universal Composite
K152004 · EBF
Nanova Biomaterials, Inc.
Dental · 120d
Cleared Nov 17, 2015
Renaissance X System
K152041 · OLO
Mazor Robotics , Ltd.
Orthopedic · 118d
Cleared Nov 17, 2015
MD-2300S Ultrasonic A/B Scanner for Ophthalmology
K152318 · IYO
MEDA Co., Ltd.
Radiology · 92d
Cleared Nov 17, 2015
TYRX Neuro Antibacterial Envelope
K152678 · FTL
Tyrx, Inc.
General & Plastic Surgery · 60d
Cleared Nov 17, 2015
DIVA ZSP5812CMI with QUBYX PerfectLum bundle
K152847 · PGY
Qubyx , Ltd.
Radiology · 49d
Cleared Nov 17, 2015
AUTOLAP SYSTEM
K152848 · GCJ
M.S.T Medical Surgery Technologies, Ltd.
General & Plastic Surgery · 49d
Cleared Nov 17, 2015
RANGE/DENALI/MESA Spinal System
K153031 · NKB
K2m, Incorporated
Orthopedic · 29d
Cleared Nov 16, 2015
GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR...
K150504 · PSW
Pci Medical, Inc.
General Hospital · 263d
Cleared Nov 16, 2015
Annuy Latex Surgeon's Gloves (Powdered and Powder Free)
K150609 · KGO
Anhui Anyu Latex Products Co., Ltd.
General Hospital · 251d
Cleared Nov 16, 2015
Annuy Latex Patient Examination Glove (powdered and powder-free)
K150612 · LYY
Anhui Anyu Latex Products Co., Ltd.
General Hospital · 251d
Cleared Nov 16, 2015
REDAPT Porous Acetabular Shell and Cemented Liner
K150790 · LPH
Smith & Nephew, Inc.
Orthopedic · 236d
Cleared Nov 16, 2015
KYPHON XPEDE Bone Cement
K151227 · NDN
Medtronic
Orthopedic · 193d