75 results · 26ms · Sources: EU EUDAMED, US FDA

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Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE

FDA 510(k)
FDA Class 2 ·Orthopedic

MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws

FDA 510(k)
FDA Class 2 ·Orthopedic

Seca 402/403 Baby Scale Cart, Ref # 4020000009/ REF # 4030000009

FDA Enforcement
Class II ·Ongoing·Seca·March 11, 2020

Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment

FDA Enforcement
Class II ·Ongoing·Btt Health Gmbh·September 25, 2024

Ofa Bamberg GmbH

Manufacturer
🇩🇪 Germany

8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image guidance and visualization capabilities in a single system. The Stryker Electromagnetic Navigation Unit (8000-010-003) powered by Scopis ENT Software with TGS (8000-021-002), allows the analysis and identification of sinus cells in the complex patient anatomy and planning of the natural drainage pathways through the sinus cavity. During surgery, the planned pathways are overlaid in real-time onto the endoscopic image, providing a unique Scopis augmented reality technology. Guidance of endoscopic instruments may help perform a minimally invasive, accurate and selective surgery.

FDA Enforcement
Class II ·Ongoing·Stryker Leibinger GmbH & Co. KG·May 29, 2024

PEGASUS PTCA Balloon Catheter

Device
EU MDD · Eu Md Class 3 ·QualiMed Innovative Medizinprodukte GmbH·On the market·1 country

CD138 (QR102)

Device
EU IVDD · Eu Ivd General ·biocyc Biotechnologie GmbH & Co. KG·On the market

SAMPLES TRANSPORT, CONTAINERS - OTHER

Device
EU IVDR · Eu Ivd Class A ·Greiner Bio-One GmbH·On the market

Bettverl.12 302

Device
EU MDR · Eu Md Class 1 ·Breckle Matratzenwerk Weida·On the market

Slim Close Tray Transfer 3.5mmDx13mmL

Device
EU MDR · Eu Md Class 1 ·MEDIGMA BIOMEDICAL GMBH·On the market·32 countries

VITA MFT®

Device
EU MDR · Eu Md Class 2a ·VITA Zahnfabrik·On the market·1 country

Ellbogenschutz M

Device
EU MDR · Eu Md Class 1 ·WUNDmed GmbH & Co. KG·On the market

adeor medical AG

Manufacturer
🇩🇪 Germany·7 Basic UDI-DIs·7 Devices·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ and SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ

newbox medical GmbH

Manufacturer
🇩🇪 Germany·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ

Kirchner & Wilhelm GmbH + Co KG

Manufacturer
🇩🇪 Germany·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ

MAYBACH ICONS OF LUXURY GMBH

FDA registration
MAYBACH ICONS OF LUXURY GMBH·2 products·🇩🇪 Germany

antibody

Basic UDI-DI
EU IVDD · Eu Ivd General ·biocyc Biotechnologie GmbH & Co. KG·1 device

Cryo.s 1ml, conical bottom, Datamatrix

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Greiner Bio-One GmbH·1 device

PC2016

Basic UDI-DI
EU MDD · Eu Md Class 3 ·QualiMed Innovative Medizinprodukte GmbH·1 device