10,000 results · 19ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

MOD. WACHS EXPORT Scheiben

Device
EU MDR · Eu Md Class 1 ·gebdi DENTAL-PRODUCTS GmbH·On the market

SMU 611 VERS. 2.0 INCLUDING PRESSNI,DILU,SAT-MOD.

FDA 510(k)
FDA Class 2 ·Cardiovascular

MOD. WACHS OPTIMA, rosa, 1,5mm / 2.500g.

Device
EU MDR · Eu Md Class 1 ·gebdi DENTAL-PRODUCTS GmbH·On the market

MOD. WACHS OPTIMA, rosa, 1,5mm / 500g.

Device
EU MDR · Eu Md Class 1 ·gebdi DENTAL-PRODUCTS GmbH·On the market

IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

FDA Enforcement
Class II ·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019

LiMAx breathing mask

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Humedics GmbH·1 device

LiMAx device

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Humedics GmbH·1 device

MCD Medical Care Dental GmbH

Importer
🇩🇪 Germany

Associates of Cape Cod Europe GmbH

Importer
🇩🇪 Germany

human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.

FDA Enforcement
Class II ·Ongoing·HUMAN MED AG·March 12, 2025

DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)

FDA Enforcement
Class II ·Ongoing·Pro-Med Instruments Gmbh·June 4, 2025

pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY The DORO(R) Skull Pins are inserted into the receptacles of the skull clamp and fixate the head during surgery.

FDA Enforcement
Class II ·Terminated·Pro-Med Instruments Gmbh·December 13, 2017

DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries

FDA Enforcement
Class I ·Terminated·Pro-Med Instruments Gmbh·September 26, 2018

DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries

FDA Enforcement
Class I ·Terminated·Pro-Med Instruments Gmbh·September 26, 2018

DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries

FDA Enforcement
Class I ·Terminated·Pro-Med Instruments Gmbh·September 26, 2018

Bürki inno med GmbH

Importer
🇩🇪 Germany·1 Manufacturer

DD601424180001

Certificate
MDD Annex V·RECA Med GmbH·TÜV Rheinland LGA Products GmbH·2 Basic UDI-DIs

DD 601424180001

Certificate
MDD Annex V·RECA Med GmbH·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

AirLife Medizintechnik

Importer
🇩🇪 Germany·2 Manufacturers

Human Med AG

System producer
🇩🇪 Germany