10,000 results
·
42ms
·
Sources: EU EUDAMED, US FDA
ANESTHESIA CONDUCTION NEEDLE
FDA 510(k)
FDA Class 2
·Anesthesiology
9.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON
FDA 510(k)
FDA Class 2
·Cardiovascular
INTRA-AORTIC BALLOON (IAB)
FDA 510(k)
FDA Class 2
·Cardiovascular
SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Cardiovascular
SONIXGPS
FDA 510(k)
FDA Class 2
·Anesthesiology
MINISCOPE MS-2
FDA 510(k)
FDA Class 2
·Cardiovascular
DATASCOPE 95 AND 97 IAB PUMP CONSOLE
FDA 510(k)
FDA Class 2
·Cardiovascular
SPINAL NEEDLES
FDA 510(k)
FDA Class 2
·Anesthesiology
ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY
FDA 510(k)
FDA Class 2
·Anesthesiology
PHARMASEAL CLEAR HUB SPINAL NEEDLE
FDA 510(k)
FDA Class 2
·Anesthesiology
Cutera, Inc.
Manufacturer
🇺🇸 United States·17 Basic UDI-DIs·21 Devices·2 Importers·TUV NORD Polska Sp. z o.o and TÜV NORD CERT GmbH
Zhongshan Bio-Tech Co., Ltd.
Manufacturer
🇨🇳 China·24 Basic UDI-DIs·24 Devices·CeCert Sp. z o.o. and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ENPULSE E1 IPG, ENPULSE E2 IPG,KAPPA D (KAPPA 700) IPG, KAP
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA DR MRI IPG,AT500 DDDRP PACING SYSTEM IPG, ENPULSE E2 IPG,ENPULSE E2 IPG,KAP
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ENTRUST ICD,INTRINSIC 30 ICD, INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD, KAPPA DR(KAPPA 700/600)IPG, KAP
Generic SV 1.67 Asp
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Vision Rx Lab Private Limited·1 device
HSO Urinbeutelhalterung
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·MSP Medizintechnik GmbH·1 device
SafeBelt
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·MSP Medizintechnik GmbH·1 device
MamaSafe
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·MSP Medizintechnik GmbH·2 devices
FersenFix
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·MSP Medizintechnik GmbH·1 device