11 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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POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR
FDA 510(k)
FDA Class 1
·General Hospital
BD¿ 3 ML BD LUER-LOK¿ BLUNT FILL NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 5, 2018
OSSEOTITE DENTAL IMPLANTS
FDA 510(k)
FDA Class 2
·Dental
BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755
FDA 510(k)
FDA Class 2
·Cardiovascular
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·November 13, 2025
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 6, 2013
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 16, 2014
VERSYS FEMORAL STEM POROUS FULLCOAT BOWED
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code LPH·April 6, 2011
HAHN TAPERED IMPLANT 3.5 X 11.5 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·April 27, 2022
Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.
FDA Enforcement
Class I
·Terminated·Stryker Spine·August 28, 2013
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