Search FDA 510(k) Database

6,877 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
16273–16296 of 174,061
Cleared Feb 03, 2021
AXUS ES-5 Electro-Acupuncture Device
K200636 · BWK
Lhasa Oms, Inc.
Neurology · 330d
Cleared Feb 03, 2021
Balex bone Expander System
K202027 · HRX
Taeyeon Medical Co., Ltd.
Orthopedic · 196d
Cleared Feb 03, 2021
Smart SPACE Shoulder System
K202151 · QHE
Techmah Medical, LLC
Orthopedic · 184d
Cleared Feb 03, 2021
Medical Face Masks
K202627 · FXX
Guilin Hbm Sanitary Protections, Inc.
General Hospital · 145d
Cleared Feb 03, 2021
Arthrex Pilon Fusion System
K203294 · HRS
Arthrex, Inc.
Orthopedic · 86d
Cleared Feb 03, 2021
EcoFit® Hip System
K203420 · LZO
Implantcast GmbH
Orthopedic · 76d
Cleared Feb 03, 2021
Omnichroma Flow Bulk
K203598 · EBF
Tokuyama Dental Corporation
Dental · 56d
Cleared Feb 02, 2021
Easydrip Pen Needle, Easydrip Plus Pen Needle
K193422 · FMI
Sandstone Medical (Suzhou), Inc.
General Hospital · 421d
Cleared Feb 02, 2021
CTxx85 CT Scanner
K201231 · JAK
Analogic Corporation
Radiology · 271d
Cleared Feb 02, 2021
3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On
K202096 · FXX
Ecoguard, Inc.
General Hospital · 188d
Cleared Feb 02, 2021
Fundus Camera
K202097 · HKI
Huvitz Co., Ltd.
Ophthalmic · 188d
Cleared Feb 02, 2021
Disposable Medical Surgical Masks
K202323 · FXX
Tianjin Teda Jinshan Easy Packing...
General Hospital · 169d
Cleared Feb 02, 2021
Medical Face Mask
K202331 · FXX
Gemtier Medical (Shanghai), Inc.
General Hospital · 169d
Cleared Feb 02, 2021
Disposable Medical Surgical Mask
K202511 · FXX
Improve Medical (Hunan) Co., Ltd.
General Hospital · 155d
Cleared Feb 02, 2021
INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers,...
K203278 · MAX
Globus Medical, Inc.
Orthopedic · 88d
Cleared Feb 02, 2021
CellFX System
K203299 · GEI
Pulse Biosciences, Inc.
General & Plastic Surgery · 85d
Cleared Feb 02, 2021
Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR
K203553 · LNH
Canon Medical Systems Corporation
Radiology · 60d
Cleared Feb 02, 2021
BioPoly Great Toe Hemiarthroplasty Implant
K203634 · KWD
BioPoly, LLC
Orthopedic · 53d
Cleared Feb 02, 2021
EzRay M (Model: VMX-P300)
K203667 · IZL
VATECH Co., Ltd.
Radiology · 48d
Cleared Feb 01, 2021
FAST-FIX FLEX
K203393 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 75d
Cleared Feb 01, 2021
Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
K203483 · KGO
Guilin Hbm Health Protections, Inc.
General Hospital · 66d
Cleared Feb 01, 2021
Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems
K203537 · KPR
Sedecal., Sa.
Radiology · 60d
Cleared Feb 01, 2021
Hoffmann LRF System
K203568 · KTT
Stryker GmbH
Orthopedic · 56d
Cleared Feb 01, 2021
Monopolar Hook
K203603 · GCJ
Human Xtensions , Ltd.
General & Plastic Surgery · 54d