25 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Radiopaque Tissue Marker
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108696400·Dynamic Dental Implant Ø6mm L13mm
LEONE SPA
FDA UDI
LEONE SPA·08033707018131·CALIBRA 1ST MOLAR BANDS n.LL 26
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450265420·
POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
PERFORMER HT/ HANG&GO HT BASIC
FDA 510(k)
FDA Class 2
·General Hospital
ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·November 11, 2020
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·June 14, 2013
BLADE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KTW·July 13, 2011
FLO-GARD 6301 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·September 24, 2008
GPSIII 30ML PLATELET CONCENTRATION KIT WITH ACD-A
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KSS·August 22, 2018
PINN CAN BONE SCREW 6.5MMX20MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·January 15, 2013
PINNACLE MTL INS NEUT36IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·January 15, 2013
S-ROM*SLEEVE PRX ZTT, 24F-XXL
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·September 25, 2012
SROM*STMLG36+21CR8L 24X19X230N
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code MRA·September 25, 2012
SUMMIT POR TAPER SZ7 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·September 25, 2012
HANG&GO HT BASIC
FDA Adverse Event
Malfunction
·RAND S.R.L.·Product code LGZ·May 15, 2017
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·February 4, 2026
Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·June 15, 2022
Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·February 2, 2022