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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

STRYKER SPINE OASYS SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

OASYS BLOCKER

FDA Adverse Event
Injury ·STRYKER SPINE-FRANCE·Product code KWP·November 30, 2015

Baltic Denture System BD Load

FDA UDI
Merz Dental GmbH·D7091032394·Baltic Denture System BDLoad Mm6 PLSEbim6DFm A4...

Mini Master Series

FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746161056·DB BKT MINI MS UL BIC 018 T-7 A=0 R=0 HGW OFFSE...

CADD SOLIS HPCA PUMP

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code MEA·March 28, 2024

JMS APHERESIS NEEDLE SET ACCORDION TYPE

FDA 510(k)
FDA Class 2 ·General Hospital

ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE

FDA 510(k)
FDA Class 2 ·Anesthesiology

NKS PM-L

FDA Adverse Event
Injury ·NAKANISHI INC. (NSK)·Product code EFB·May 26, 2015

EON MINI

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 29, 2013

UNKNOWN SIZE 4 CR FEMUR

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·March 28, 2011

PIC

FDA Adverse Event
Malfunction ·WELCH ALLYN PROTOCOL, INC.·Product code MKJ·April 16, 2008

BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

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

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

Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013