15 results · 29ms · Sources: EU EUDAMED, US FDA

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LARGE BORE SPLITTABLE INTRODUCER KIT

FDA 510(k)
FDA Class 2 ·Cardiovascular

SMART RAD

FDA 510(k)
FDA Class 2 ·Radiology

FRIALIT-2 ESTHETICBASE ABUTMENT

FDA 510(k)
FDA Class 2 ·Dental

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 11, 2020

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 11, 2020

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·October 8, 2020

ALARIS PUMP MODULE ADMINISTRATION SET

FDA Adverse Event
Malfunction ·CAREFUSION CORP.·Product code FPA·March 13, 2013

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 28, 2011

ENDOTAK RELIANCE

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 12, 2020

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 25, 2020

FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS

FDA Adverse Event
Injury ·COOK INC·Product code EZN·May 21, 2019

Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

FDA Enforcement
Class I ·Ongoing·Thoratec Corp.·May 8, 2024

Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

FDA Enforcement
Class I ·Ongoing·Thoratec Corp.·May 8, 2024

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