Search FDA 510(k) Database

7,147 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
21841–21864 of 174,061
Cleared Mar 06, 2019
GenePOC Strep A
K183366 · PGX
Genepoc, Inc.
Microbiology · 92d
Cleared Mar 06, 2019
ChoiceSpine Stealth Cervical Spacer System
K183397 · ODP
Choicespine, LP
Orthopedic · 89d
Cleared Mar 05, 2019
MAC Medical D-Series Blanket and Solution Warming Cabinets
K180842 · LGZ
Mac Medical, Inc.
General Hospital · 340d
Cleared Mar 05, 2019
ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)
K181656 · LPL
Eyemed Technologies S.R.L.
Ophthalmic · 256d
Cleared Mar 05, 2019
Imagio Ultrasound Imaging System
K182628 · IYN
Seno Medical Instruments, Inc.
Radiology · 162d
Cleared Mar 05, 2019
Olympus Small Intestinal Capsule Endoscope System
K183053 · NEZ
Olympus Medical Systems Corp.
Gastroenterology & Urology · 123d
Cleared Mar 05, 2019
Stryker SternalPlate System
K183172 · HRS
Stryker
Orthopedic · 109d
Cleared Mar 05, 2019
Embrella Endoscopic Distal Attachment
K190030 · FED
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 57d
Cleared Mar 04, 2019
Medline Reinforced Epidural Catheter
K181782 · BSO
Medline Industries, Inc.
Anesthesiology · 244d
Cleared Mar 04, 2019
MLP Special Locking Bone Plate System
K181843 · HRS
Maxxion Medical, LLC / Baumer SA
Orthopedic · 236d
Cleared Mar 04, 2019
Dimension Vista High-Sensitivity Troponin I (TNIH) Assay
K182225 · MMI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 200d
Cleared Mar 04, 2019
JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant,...
K183384 · NUC
United Consortium
Obstetrics & Gynecology · 88d
Cleared Mar 04, 2019
VS3-IR
K183453 · OWN
Medtronic
General & Plastic Surgery · 81d
Cleared Mar 04, 2019
SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices
K190193 · MAX
Spineex, Inc.
Orthopedic · 28d
Cleared Mar 04, 2019
SCARLET® AC-T Secured Anterior Cervical Cage
K190322 · ODP
Spineart
Orthopedic · 19d
Cleared Mar 03, 2019
Electronic Blood Pressure Monitor
K182495 · DXN
Shenzhen Jumper Medical Equipment...
Cardiovascular · 173d
Cleared Mar 01, 2019
XactTrace Single Use Respiratory Effort Belt System
K173793 · MNR
Embla Systems
Anesthesiology · 442d
Cleared Mar 01, 2019
CurvaFix Intramedullary Rodscrew System
K180050 · HWC
Curvafix, Inc.
Orthopedic · 417d
Cleared Mar 01, 2019
Manual Wheelchair
K180852 · IOR
Jiangyin Newrise Medical Equipment...
Physical Medicine · 333d
Cleared Mar 01, 2019
DxH 520 Hematology Instrument
K181475 · GKZ
Beckman Coulter
Hematology · 270d
Cleared Mar 01, 2019
BD Vacutainer Eclipse UltraFill Blood Collection Needle
K181730 · FMI
Becton, Dickinson and Company
General Hospital · 245d
Cleared Mar 01, 2019
Lead-free Chemical Indicators for Steam Sterilization
K181788 · JOJ
Kem Medical Products Corp.
General Hospital · 239d
Cleared Mar 01, 2019
EliA Celikey IgG Immunoassay
K181871 · MVM
Phadia AB
Immunology · 232d
Cleared Mar 01, 2019
DTX Studio design
K181932 · PNP
Nobel Biocare AB
Dental · 225d