Search FDA 510(k) Database

Cleared May 16, 2022

Caas Qardia

K212376 · LLZ

Pie Medical Imaging BV

Radiology · 290d

Cleared May 16, 2022

Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems

K213583 · LNH

Philips Medical Systems Nederland B.V.

Radiology · 185d

Cleared May 16, 2022

AAMI3 Isolation Gown

K213832 · FYC

Hubei Xinxin Non-Woven Co., Ltd.

General Hospital · 158d

Cleared May 16, 2022

STERRAD NX with ALLClear Technology

K220404 · MLR

Advanced Sterilization Products, Inc.

General Hospital · 91d

Cleared May 16, 2022

IPL HAIR REMOVAL HANDSET, Model: IPL-666

K220669 · OHT

Shenzhen Junbobeauty Technology Co.,...

General & Plastic Surgery · 70d

Cleared May 14, 2022

Disposable Medical Nitrile Examination Gloves -Tested for Use with...

K220491 · LZC

Hainan Asther Medical Equipment Co.,...

General Hospital · 81d

Cleared May 14, 2022

Introcan Safety IV Catheter

K220626 · FOZ

B.Braun Medical, Inc.

General Hospital · 71d

Cleared May 13, 2022

HDF Assist Mudule, HDF Infusion Set and Substitution Filter

K210575 · KDI

Nephros

Gastroenterology & Urology · 441d

Cleared May 13, 2022

Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull...

K210615 · GZT

Thompson Surgical Instruments, Inc.

Neurology · 438d

Cleared May 13, 2022

Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)

K212475 · EJK

Prevest Denpro Limited

Dental · 280d

Cleared May 13, 2022

Spectral CT on Rails

K212875 · JAK

Philips Medical Systems Nederland B.V.

Radiology · 246d

Cleared May 13, 2022

Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens

K213119 · LPL

Innova Vision, Inc.

Ophthalmic · 228d

Cleared May 13, 2022

INTDose

K213137 · IYE

Carina Medical, LLC

Radiology · 228d

Cleared May 13, 2022

Provena(TM) Midline Catheter

K213203 · PND

C.R. Bard, Inc.

General Hospital · 226d

Cleared May 13, 2022

Sterile Safety Hypodermic Needles for Single Use

K213535 · FMI

Zhejiang Kangkang Medical-Devices...

General Hospital · 189d

Cleared May 13, 2022

SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid

K213785 · KWS

Limacorporate

Orthopedic · 158d

Cleared May 13, 2022

ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System

K220115 · OVD

MiRus, LLC

Orthopedic · 119d

Cleared May 13, 2022

Zone Specific AIM

K220186 · GAT

Conmed Corporation

General & Plastic Surgery · 109d

Cleared May 13, 2022

Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)

K220411 · NUJ

Stryker Sustainability Solutions

General & Plastic Surgery · 88d

Cleared May 13, 2022

Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile

K220429 · LZA

One Glove Industrial Sdn Bhd

General Hospital · 87d

Cleared May 13, 2022

MAGNETOM Skyra Fit

K220589 · LNH

Siemens Medical Solutions USA, Inc.

Radiology · 73d

Cleared May 13, 2022

Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP

K220749 · FXX

Unimax Medical Products Co., Ltd.

General Hospital · 60d

Cleared May 13, 2022

Argo Knotless SP Anchor

K220757 · MBI

Conmed Corporation

Orthopedic · 59d

Cleared May 13, 2022

Pre-Formed Penile Silicone Block

K220760 · MIB

International Medical Devices, Inc.

General & Plastic Surgery · 59d