57 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Germany
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OrthoPreventAligner® PR-W hard
Device
EU MDR
·
Eu Md Class 1
·Dr. Hinz Dental-Vertriebsgesellschaft mbH & Co. KG·On the market·1 country
OrthoPreventAligner® PR-W soft
Device
EU MDR
·
Eu Md Class 1
·Dr. Hinz Dental-Vertriebsgesellschaft mbH & Co. KG·On the market·1 country
bess pro gmbh
Manufacturer
🇩🇪 Germany·1 Basic UDI-DI·2 Devices
Ophthalmo Pro GmbH
Manufacturer
🇩🇪 Germany
PRO-MED Instrumente GmbH
Manufacturer
🇩🇪 Germany
pro med instruments GmbH
Manufacturer
🇩🇪 Germany
PRO ACTIV Reha-Technik GmbH
Manufacturer
🇩🇪 Germany
tpm taberna pro medicum GmbH
Manufacturer
🇩🇪 Germany
OrthoPreventAligner® BR-W
Device
EU MDR
·
Eu Md Class 1
·Dr. Hinz Dental-Vertriebsgesellschaft mbH & Co. KG·On the market·1 country
Pro Dimi Healthcare GmbH & Co. KG
Manufacturer
🇩🇪 Germany·3 Basic UDI-DIs·20 Devices
Pro Eyes GmbH part of LoQu Optical Group
Manufacturer
🇩🇪 Germany
GRW - 100 1" ST
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·BEKA-Hospitec GmbH·30 devices
SILICONE DRESSINGS, NON-COMBINED
Device
EU MDR
·
Eu Md Class 2a
·bess pro gmbh·On the market·10 countries
SILICONE DRESSINGS, NON-COMBINED
Device
EU MDR
·
Eu Md Class 2a
·bess pro gmbh·On the market·10 countries
PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.
FDA Enforcement
Class II
·Terminated·PTW-Freiburg·September 2, 2015
Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.
FDA Enforcement
Class II
·Ongoing·PTW-FREIBURG·February 28, 2024
BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using ArrayCal (module from BeamAdjust S080032, UDI-DI: EPTWS0800320 ): " OCTAVIUS Detector 1600 SRS (T10056) (UDI-DI: EPTWT100560) " OCTAVIUS Detector 1600 MR (T10057) (UDI-DI: EPTWT100570) " OCTAVIUS Detector 1600 XDR (T10058) (UDI-DI: EPTWT100580) " OCTAVIUS Detector 1000 SRS (T10036) (UDI-DI: EPTWT100360)
FDA Enforcement
Class II
·Ongoing·PTW-FREIBURG·September 20, 2023
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