25 results · 22ms · Sources: EU EUDAMED, 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