91 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Atos Medical
FDA UDI
ATOS MEDICAL INC.·00817126020931·2010-068 Laryngectomy Pulmonary Kit with Standa...
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100080·Dilator Sleeve, Probe
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100180·SNII Tap, 6.50mm
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K0100080·Caddie Lid, Implants and Instruments
NBS CONNECTING TUBE SET
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
COMPUMEDICS E-SERIES EEG SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 6, 2025
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·September 3, 2025
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER
AXSYM DIGOXIN III
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP·Product code LZG·February 11, 2011
HEARTWARE VENTRICULAR ASSIST SYSTEM - WAIST PACK
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·September 16, 2025
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MRU·November 7, 2016
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·NAVISTAR & EZ STEER FAMILIES OF CATHETERS
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Navistar/Celsius DS Diagnostic/Ablation Deflectable 8MM Tip Catheter
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·7 FR EZ STEER NAV DS BI-DIRECTIONAL W/ 8MM TIP ELECTRODE W/ DUAL THERMOCOUPLE
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·EZ Steer Navigational 8mm (DS) ; Celsius FLTR Uni-Dir.
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·CELSIUS RMT, NAVISTAR RMT AND NAVISTAR RMT DS CATHETERS