21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
AMDS Hybrid Prosthesis ("AMDS")
FDA UDI
Artivion, Inc.·00877234001208·40mm – 30mm Tapered Stent (24mm collar)
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120304211·Diamond, cylinder flat, medium grit
BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DEPUY C-STEM SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRA WAVEWRITER?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 4, 2025
BD LUER-LOK¿ TIP SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·April 8, 2023
PRONOVA BLUE MONO POLY(HEXAFLUOROPROPYLENE)SUTURE
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code GAW·April 2, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS INNOVATION CENTER - SILICON VALLEY·Product code GEX·March 7, 2011
MERCI RETRIEVER L4
FDA Adverse Event
Malfunction
·CONCENTRIC MEDICAL, INC.·Product code NRY·April 17, 2008
TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE GH
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·June 5, 2018
PS TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 10-12 GH TOP
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·June 5, 2018
TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE GH
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·June 5, 2018
PS TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 10-12 GH TOP
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·June 5, 2018
PERFORMATRAK MASK
FDA Adverse Event
Death
·RESPIRONICS, INC.·Product code BZD·December 15, 2020
BD LUER-LOK¿ TIP SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·April 8, 2023
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
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