11 results · 26ms · Sources: EU EUDAMED, US FDA

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SUBTALAR ARTHRORISIS IMPLANT

FDA 510(k)
FDA Class 2 ·Orthopedic

Baltic Denture System BD Load

FDA UDI
Merz Dental GmbH·D7091032902·Baltic Denture System BDLoad Lw6 PLSEbil2DFl B3...

TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

POLY PER-Q-CATH SINGLE LUMEN PICC CATHETER, MODEL 3143100; POLY PER-Q-CATH DUAL LUMEN PICC CATHETER, MODEL 3246100

FDA 510(k)
FDA Class 2 ·General Hospital

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·April 3, 2013

TRANSFER SET

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·March 29, 2011

OMNI-FLOW MODEL 4000 PLUS

FDA Adverse Event
Malfunction ·HOSPIRA, INC.·Product code FRN·April 23, 2008

THERMACARE NECK/SHOULDER/WRIST

FDA Adverse Event
Injury ·BRIDGES CONSUMER HEALTHCARE·Product code IMD·December 27, 2023

CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

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

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024