Search FDA 510(k) Database

Cleared Nov 03, 2022

Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes,...

K220263 · HQB

Vortex Surgical, Inc.

Ophthalmic · 276d

Cleared Nov 03, 2022

ibiomedi Electronic Stethoscope ES-2020

K220466 · DQD

Sound Land Corp.

Cardiovascular · 259d

Cleared Nov 03, 2022

Insulin Syringes without needle

K221045 · FMF

Berpu Medical Technology Co., Ltd.

General Hospital · 209d

Cleared Nov 03, 2022

NP Medical nCompass Extension Set with Stabilizing Base

K221518 · FPA

Np Medical

General Hospital · 162d

Cleared Nov 03, 2022

ABTross ALIF Expandable Cage System

K221719 · MAX

Aegis Spine, Inc.

Orthopedic · 143d

Cleared Nov 03, 2022

Black Diamond™ POCT Spinal System

K222107 · NKG

Osseus Fusion Systems

Orthopedic · 108d

Cleared Nov 03, 2022

Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie...

K222168 · FMK

Owen Mumford, Ltd.

General & Plastic Surgery · 105d

Cleared Nov 03, 2022

Led Mask Platinum Md

K222377 · OHS

Cellreturn Co., Ltd.

General & Plastic Surgery · 90d

Cleared Nov 03, 2022

truSculpt iD

K223110 · GEI

Cutera, Inc.

General & Plastic Surgery · 31d

Cleared Nov 03, 2022

Tera Harz Clear

K223355 · NXC

Graphy, Inc.

Dental · 1d

Cleared Nov 02, 2022

Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for...

K211816 · LZA

Brightway Holdings Sdn. Bhd.

General Hospital · 509d

Cleared Nov 02, 2022

Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded...

K220371 · LZA

Summit Glove, Inc.

General Hospital · 266d

Cleared Nov 02, 2022

ORiGO System

K221184 · ERL

Bien-Air Surgery SA

Ear, Nose, Throat · 191d

Cleared Nov 02, 2022

OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance...

K222084 · FMK

Asahi Polyslider Co., Ltd.

General & Plastic Surgery · 110d

Cleared Nov 02, 2022

Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo

K222395 · HQF

Ellex Medical Pty, Ltd.

Ophthalmic · 86d

Cleared Nov 02, 2022

Powder Free Nitrile Examination Gloves (Blue), Tested for Use with...

K223320 · LZA

Lingshi Hongruida Health Protection...

General Hospital · 5d

Cleared Nov 01, 2022

Back 3 COLOR

K214090 · PBX

Swims America Corp

General & Plastic Surgery · 308d

Cleared Nov 01, 2022

Klarity SRS Baseplate, Klarity Promise Baseplate

K220539 · IYE

Klarity Medical & Equipment (GZ) Co.,...

Radiology · 249d

Cleared Nov 01, 2022

Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe...

K221247 · MEG

Jiangsu Kangbao Medical Equipment...

General Hospital · 183d

Cleared Nov 01, 2022

Dolphin Blue Imaging

K221478 · LLZ

Patterson Dental Supply, Inc.

Radiology · 162d

Cleared Nov 01, 2022

Combined High Frequency X-ray Source

K222258 · IZL

Suzhou Powersite Electric Co., Ltd.

Radiology · 97d

Cleared Nov 01, 2022

3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248

K222508 · JOJ

3M Company

General Hospital · 75d

Cleared Nov 01, 2022

Current Health System

K222550 · MSX

Current Health , Ltd.

Cardiovascular · 70d

Cleared Nov 01, 2022

POSE™ Health Care Surgical Mask

K223270 · FXX

America?S Supply Chains

General Hospital · 8d