75 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Germany
×
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