13 results · 20ms · Sources: EU EUDAMED, US FDA

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BLACKSTONE POSTERIOR CERVICAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

DeRoyal

FDA UDI
DEROYAL INDUSTRIES, INC.·00749756001618·Knee Immobilizer

VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES, YELLOW

FDA 510(k)
FDA Class 1 ·General Hospital

CORTEK CYSTOSCOPE

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

BD PHASEAL PROTECTOR P50J

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·July 7, 2023

ACCU-CHEK SPIRIT COMBO

FDA Adverse Event
Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·April 2, 2013

6800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 7, 2011

CURL CATH 62CM 2 CUFF

FDA Adverse Event
Malfunction ·COSTA RICA, COVIDIEN MANUFACTURING·Product code MSD·July 15, 2014

Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

FDA Enforcement
Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

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