20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NUVASIVE NEUROVISION JJB SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496032083·MISS RELAX 70 SHEER, SIZE S, BRONZE, GRADUATED ...
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120320831·Diamond, cylinder rounded edge, COOL DIAMANT, m...
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0380830·T-Handle, Ratcheting, Quarter Square Collar
LORENZ RESORBABLE DISTRACTOR SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218
FDA 510(k)
FDA Class 2
·Cardiovascular
AMINGO
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·December 9, 2016
ORTHO SUMMIT SAMPLE HANDLER
FDA Adverse Event
Malfunction
·HAMILTON BONADUZ AG·Product code JTC·August 18, 1999
AMINGO
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·December 30, 2016
AMINGO
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·December 29, 2016
AMINGO
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·January 4, 2017
PROGRASP FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·April 29, 2014
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·FLEXTRONICS EMS CANADA·Product code FNL·March 6, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 28, 2011
ASCENSIA CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·April 18, 2008
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
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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