27 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PMT CORPORATION - STEREOTACTIC
FDA UDI
PMT CORPORATION·00650551141440·ROSA BUSHING, FOR 2.4MM DRILL, BLACK
NexxZr™ / W-98-22-UT-D300-ML
FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271139795·
TAYLOR UNIVERSAL DRILL GUIDE
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896051881·TAYLOR UNIVERSAL DRILL GUIDE
CADD CASSETTE 100ML W/FLOWSTOP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FPA·June 23, 2021
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 8, 2023
ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (CLEAR AND TINT
FDA 510(k)
FDA Class 2
·Ophthalmic
REEFLEX PTA CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·June 16, 2010
XPERT PRO SELF-EXPANDING STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code FGE·April 13, 2017
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·February 9, 2010
HOOK/SCREW HOLDER WITH 4.0MM HEX
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code LXH·May 9, 2013
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 19, 2014
TRUFILL DCS ORBIT MINI COMPLEX FILL
FDA Adverse Event
Malfunction
·CORDIS NEUROVASCULAR, INC.·Product code HCG·May 25, 2011
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
FDA Enforcement
Class III
·Terminated·Illumina Inc·December 31, 2014
Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End Servers- 10910620 Sensis Vibe Hemo- 11007641 Sensis Vibe Combo- 11007642 Sensis Vibe is a recording and procedure data management system for interventional cardiology, interventional radiology, surgical procedures performed in a hybrid OR and electrophysiology
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·April 28, 2021
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·November 6, 2024
1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis recording system is a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac, interventional Radiology, and surgical studies.
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 26, 2022
Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·November 24, 2021
Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.
FDA Enforcement
Class II
·Terminated·ConvaTec, Inc·March 9, 2016