16 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)
FDA 510(k)
FDA Class 2
·General Hospital
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032393·Baltic Denture System BDLoad ↓ Mn6 PLSEum2DFm A...
Mini Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746161049·DB BKT MINI MS UR BIC 018 T-7 A=0 R=0 HGW OFFSE...
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102848·FUKASAKU SMALL PUPIL SNAPPER HOOK
NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TINA-QUANT TRANSFERRIN VER.2
FDA 510(k)
FDA Class 2
·Immunology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 12, 2026
OASYS BLOCKER
FDA Adverse Event
Injury
·STRYKER SPINE-FRANCE·Product code KWP·November 30, 2015
NKS PM-L
FDA Adverse Event
Injury
·NAKANISHI INC. (NSK)·Product code EFB·May 26, 2015
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 1, 2013
DUR MAR 10D LINER 28IDX48OD
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code LPH·March 28, 2011
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code LDD·April 17, 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