15 results · 21ms · Sources: EU EUDAMED, US FDA

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K-FIX

FDA 510(k)
FDA Class 2 ·Orthopedic

16PW - Cal OSHA

FDA UDI
Certified Safety Manufacturing, Inc.·00766588025971·16PW - Cal OSHA

STERILMED REPROCESSED COMPRESSION SLEEVES

FDA 510(k)
FDA Class 2 ·Cardiovascular

CN ACQUISITION STATION

FDA 510(k)
FDA Class 2 ·Radiology

CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code KNS·March 15, 2019

G7 NEUTRAL E1 LINER 32MM F

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code PBI·May 4, 2021

HEARTWARE VENTRICULAR ASSIST SYSTEM-SEWING RING

FDA Adverse Event
Injury ·HEARTWARE, INC.·Product code DSQ·September 11, 2018

HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

FDA Adverse Event
Injury ·CODMAN & SHURTLEFF, INC.·Product code JXG·March 27, 2013

PRECISION XTRA

FDA Adverse Event
Malfunction ·Product code NBW·March 17, 2011

NEXSTENT MONORAIL

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC·Product code NIM·April 1, 2008

CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code KNS·February 4, 2019

CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code KNS·August 8, 2018

CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code KNS·August 8, 2019

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

The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018