Medical Device Catalogue

20+ devices

EUDAMED Clear all

KARL STORZ Trocars with Valve Seals Ref K254228

Karl Storz SE & CO. KG,FDA registration: United States

Active Regimes: CE MDR 510(k) Registry: EUDAMED510(k)GUDID Class:II
Neodent Implant System - Helix Short Implant System Ref K223638

JJGC Indústria e Comércio de Materiais Dentários S/A.,Brazil

Active Regimes: CE MDR 510(k) Registry: EUDAMED510(k)GUDID Class:II
CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays Ref K241893

Medos International SARL,Switzerland

Active Regimes: CE MDR 510(k) Registry: EUDAMED510(k)GUDID Class:II
ETEST Delafloxacin (DFX) (0.002-32 µg/mL) Ref K192738

Biomerieux S.A.,France(FDA applicant)

Active Regimes: CE IVDR 510(k) Registry: EUDAMED510(k)GUDID Class:II
EasyOne Sky Spirometer Ref K230178

NDD Medizintechnik AG,Switzerland

Active Regimes: CE MDR 510(k) Registry: EUDAMED510(k)GUDID Class:II
Xelis Dental 2.0 Ref K193369

Infinitt Healthcare Co., Ltd.,South Korea

Active Regimes: CE MDD 510(k) Registry: EUDAMED510(k)GUDID Class:II
Opal Seal Ref K090355

Ultradent Products, Inc.,United States

Active Regimes: CE MDR 510(k) Registry: EUDAMED510(k)GUDID Class:II
FEMTO LDV Z8 Femtosecond Surgical Laser Ref K213559

SIE AG, Surgical Instrument Engineering,Switzerland

Active Regimes: CE MDR 510(k) Registry: EUDAMED510(k)GUDID Class:II
Structur CAD Ref K201090

VOCO GmbH,Germany

Active Regimes: CE MDR CE MDD 510(k) Registry: EUDAMED510(k)GUDID Class:II
ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material Ref K143687

Siemens Healthcare Diagnostics, Inc.,FDA registration: United States

Active Regimes: CE IVDR 510(k) Registry: EUDAMED510(k)GUDID Class:I
Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141) Ref K233880

Shenzhen Root Innovation Technology Co., Ltd.,China

Active Regimes: CE MDR 510(k) Registry: EUDAMED510(k)GUDID Class:II
PLEX Elite 9000 SS-OCT Ref K161194

Carl Zeiss Meditec, Inc.,United States

Active Regimes: CE MDR 510(k) Registry: EUDAMED510(k)GUDID Class:II
Neptune Waste Management Ststem Ref K012991

Stryker Instruments,United States

Active Regimes: CE MDR 510(k) Registry: EUDAMED510(k)GUDID Class:II
GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating Ref K212742 Open recall

WALDEMAR LINK GmbH & Co. KG,FDA registration: United States

Active Regimes: CE MDR 510(k) Registry: EUDAMED510(k)GUDID Class:II
aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 Ref K161696

aap Implantate AG,FDA registration: Germany

Active Regimes: CE MDR 510(k) Registry: EUDAMED510(k)GUDID Class:II
Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068) Ref K250267

Kettenbach GmbH & Co. KG,Germany

Active Regimes: CE MDR 510(k) Registry: EUDAMED510(k)GUDID Class:II
STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY™ Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY™ Reader (43220); ULTRA GI™ Process Challenge Device (PCD) (43400)(30 count) Ref K234084

Advanced Sterilization Products, Inc.,United States

Active Regimes: CE MDR 510(k) Registry: EUDAMED510(k)GUDID Class:II
LaserShot M, NaviLase Ref K192008

Vitrolife GmbH,Germany

Active Regimes: CE MDR 510(k) Registry: EUDAMED510(k)GUDID Class:II
O2 Concepts Oxlife Independence Model 301-0001 Ref K182454

O2 Concepts, LLC,United States

Active Regimes: CE MDR 510(k) Registry: EUDAMED510(k)GUDID Class:II
AHMED ClearPath Glaucoma Drainage Device Ref K182518

New World Medical, Inc.,United States

Active Regimes: CE MDD 510(k) Registry: EUDAMED510(k)GUDID Class:II

Devices

Category (EMDN)

KARL STORZ Trocars with Valve Seals Ref K254228

Neodent Implant System - Helix Short Implant System Ref K223638

CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays Ref K241893

ETEST Delafloxacin (DFX) (0.002-32 µg/mL) Ref K192738

EasyOne Sky Spirometer Ref K230178

Xelis Dental 2.0 Ref K193369

Opal Seal Ref K090355

FEMTO LDV Z8 Femtosecond Surgical Laser Ref K213559

Structur CAD Ref K201090

ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material Ref K143687

Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141) Ref K233880

PLEX Elite 9000 SS-OCT Ref K161194

Neptune Waste Management Ststem Ref K012991

GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating Ref K212742 Open recall

aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 Ref K161696

Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068) Ref K250267

LaserShot M, NaviLase Ref K192008

O2 Concepts Oxlife Independence Model 301-0001 Ref K182454

AHMED ClearPath Glaucoma Drainage Device Ref K182518