Search FDA 510(k) Database

Cleared Feb 06, 2019

WavelinQ 4F EndoAVF System

K182796 · PQK

C.R. Bard, Inc.

Cardiovascular · 128d

Cleared Feb 06, 2019

Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion...

K182885 · KWQ

Medtronic Sofamor Danek USA, Inc.

Orthopedic · 114d

Cleared Feb 06, 2019

SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments,...

K183119 · OUR

Globus Medical, Inc.

Orthopedic · 89d

Cleared Feb 06, 2019

Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black

K183435 · GDW

Ethicon Endo-Surgery, LLC

General & Plastic Surgery · 57d

Cleared Feb 06, 2019

Omnia Medical Rotary PLIF System

K183659 · MAX

Omnia Medical, LLC

Orthopedic · 41d

Cleared Feb 06, 2019

DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives

K190045 · LPL

Alcon Laboratories, Inc.

Ophthalmic · 28d

Cleared Feb 05, 2019

Absoanchor Microimplant

K181142 · OAT

Dentos, Inc.

Dental · 280d

Cleared Feb 05, 2019

PRECICE® BONE TRANSPORT™ System

K182170 · HSB

Nuvasive Specialized Orthopedics, Inc.

Orthopedic · 179d

Cleared Feb 05, 2019

Spectra Optia Apheresis System

K183081 · LKN

Terumobct, Inc.

Gastroenterology & Urology · 91d

Cleared Feb 05, 2019

Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with...

K183132 · LZC

O&M Halyard, Inc.

General Hospital · 84d

Cleared Feb 05, 2019

Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix

K183163 · MRD

Motiva USA, LLC

General & Plastic Surgery · 82d

Cleared Feb 05, 2019

JADE Mobile X-Ray

K183388 · IZL

DRGEM Corporation

Radiology · 61d

Cleared Feb 05, 2019

JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor

K183498 · PGY

Nanjing Jusha Display Technology Co.,...

Radiology · 50d

Cleared Feb 04, 2019

d-Nav System

K181916 · NDC

Hygieia, Inc.

General Hospital · 202d

Cleared Feb 04, 2019

EIT Cellular Titanium Lumbar Cage - T/PLIF

K183447 · MAX

Eit Emerging Implant Technologies GmbH

Orthopedic · 54d

Cleared Feb 04, 2019

JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor

K183499 · PGY

Nanjing Jusha Display Technology Co.,...

Radiology · 49d

Cleared Feb 04, 2019

Capture-CMV

K183571 · LJO

Immucor, Inc.

Microbiology · 45d

Cleared Feb 04, 2019

Velofix Interbody Fusion System

K190067 · ODP

U&I Corporation

Orthopedic · 20d

Cleared Feb 01, 2019

Pedimax II - Pedicular Screw Spinal System

K180626 · NKB

Gm Dos Reis Industria E Comerico Ltda.

Orthopedic · 329d

Cleared Feb 01, 2019

iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)

K181070 · NBW

Andon Health Co, Ltd.

Chemistry · 284d

Cleared Feb 01, 2019

easyLCTM Linear Cutter Staplers and Loading Units fot Single Use

K181657 · GDW

Ezisurg Medical Co., Ltd.

General & Plastic Surgery · 224d

Cleared Feb 01, 2019

HemoCue Hb 801 System

K181751 · GKR

Hemocue AB

Hematology · 214d

Cleared Feb 01, 2019

Family of Venus RF Systems - Heal

K182094 · PBX

Venus Concept USA, Inc.

General & Plastic Surgery · 182d

Cleared Feb 01, 2019

Invia Abdominal Dressing Kit

K182191 · OMP

Medela AG

General & Plastic Surgery · 172d