25 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PARIETEX PLUG AND PATCH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Medline Industries, Inc.
FDA UDI
MEDLINE INDUSTRIES, INC.·10195327642396·CV SURGEON ECMO BIN
BETA TITANIUM ARCHWIRE
FDA UDI
Ortho Organizers, Inc.·00190707067519·.018 X .025 Lower Beta Titanium Oval Arch Form ...
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383501446·Gutta Percha Points is used to root canal filin...
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973646·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973561·
AMEDA HYGIENIKIT
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
ACTICOAT 7 DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·August 4, 2020
CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·August 4, 2020
SYNGO SUITE FOR ONCOLOGY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code MUJ·November 9, 2012
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 2, 2013
QUANTA SYSTEM S.P.A.
FDA Adverse Event
QUANTA SYSTEM, S.P.A.·Product code GEX·August 29, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 20, 2011
STEM: SMS SOLID SMS SOLID STEM LAT SIZE 9
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2021
TherMax Blood Warmer Unit
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·November 6, 2019
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Model Number L210 PROPONENT SR SL Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021