Search FDA 510(k) Database

Cleared Mar 02, 2020

Anjon Bremer Halo System

K193256 · JEC

Anjon Holdings, LLC

Orthopedic · 97d

Cleared Mar 02, 2020

BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider

K193356 · GEI

Covidien, LLC

Ear, Nose, Throat · 89d

Cleared Mar 02, 2020

CarboClear Lumbar Cage System

K193378 · MAX

CarboFix Orthopedics , Ltd.

Orthopedic · 88d

Cleared Mar 02, 2020

LIAISON Anti-HAV Assay

K193532 · LOL

DiaSorin, Inc.

Microbiology · 73d

Cleared Feb 29, 2020

Kingon P2 Oxygen Concentrator

K190304 · CAW

Qingdao Kingon Medical Science and...

Anesthesiology · 382d

Cleared Feb 28, 2020

i-STAT CHEM8+ cartridge with the i-STAT 1 System

K183680 · JPI

Abbott Point of Care, Inc.

Hematology · 427d

Cleared Feb 28, 2020

Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)

K191246 · DTZ

Chalice Medical , Ltd.

Cardiovascular · 295d

Cleared Feb 28, 2020

HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length

K191555 · LFL

Ethicon Endo-Surgery, LLC

General & Plastic Surgery · 261d

Cleared Feb 28, 2020

Red Dot

K191556 · QFM

Behold.Ai Technologies Limited

Radiology · 261d

Cleared Feb 28, 2020

AccuContour

K191928 · QKB

Xiamen Manteia Technology , Ltd.

Radiology · 224d

Cleared Feb 28, 2020

Steripath Gen2 Blood Collection System

K192247 · JKA

Magnolia Medical Technologies, Inc.

General Hospital · 193d

Cleared Feb 28, 2020

scaffolene CL100 Bioresorbable Collagen Matrix

K192346 · KGN

Freudenberg Technology Innovation SE...

General & Plastic Surgery · 183d

Cleared Feb 28, 2020

Superelastic Staple

K192447 · JDR

Neosteo

Orthopedic · 175d

Cleared Feb 28, 2020

Magnetom Sola, Magnetom Altea and Magnetom Sola Fit

K192496 · LNH

Siemens Medical Solutions USA, Inc.

Radiology · 170d

Cleared Feb 28, 2020

Atlas Spine Expandable Cervical Standalone Interbody System

K192570 · OVE

Atlas Spine, Inc.

Orthopedic · 163d

Cleared Feb 28, 2020

Zimmer M/L Taper Hip Prosthesis

K192660 · LZO

Zimmer, Inc.

Orthopedic · 156d

Cleared Feb 28, 2020

SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use...

K192820 · KGO

Medline Industries, Inc.

General Hospital · 150d

Cleared Feb 28, 2020

icobrain-ctp

K192962 · LLZ

Icometrix NV

Radiology · 129d

Cleared Feb 28, 2020

CONQUEST FN

K193029 · JDO

Smith & Nephew, Inc.

Orthopedic · 121d

Cleared Feb 28, 2020

Alta Multipurpose Device

K193243 · IYE

Qfix

Radiology · 95d

Cleared Feb 28, 2020

Cellvizio I.V.E. with Confocal Miniprobes

K193416 · OWN

Mauna Kea Technologies

General & Plastic Surgery · 81d

Cleared Feb 28, 2020

Basal-IQ Technology

K193483 · QJS

Tandem Diabetes Care, Inc.

Chemistry · 73d

Cleared Feb 28, 2020

Therm-X

K193550 · IRP

Zenith Technical Innovations

Physical Medicine · 70d

Cleared Feb 28, 2020

CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid...

K200221 · JAQ

Mick Radio-Nuclear Instruments, Inc.

Radiology · 30d