15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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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