19 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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O-RING PROSTHETIC ATTACHMENT
FDA 510(k)
FDA Class 2
·Dental
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001638·artVeneer life upper anteriors, BIM, BL4
Scanlan® SURG-I-BAND® color coding
FDA UDI
SCANLAN INTERNATIONAL INC·00846159001358·Scanlan® SURG-I-BAND® color coding - Narrow, Gl...
Thuvera
FDA UDI
IPG Medical Corporation·00810071230059·Thuvera, Flat Tip, Single-Use Laser Fiber, 550um
TUFF UNICON IMPLANT
FDA Adverse Event
Malfunction
·NORIS MEDICAL LTD·Product code DZE·March 16, 2026
RESPONDER 3000
FDA 510(k)
FDA Class 3
·Cardiovascular
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354
FDA 510(k)
FDA Class 2
·Cardiovascular
TUFF UNICON IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·November 6, 2025
CS300
FDA Adverse Event
Malfunction
·DATASCOPE CORP·Product code DSP·May 9, 2014
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Injury
·COOK, INC.·Product code DRE·March 8, 2013
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code LYL·February 18, 2011
PRECISION LINK
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·February 7, 2008
FEMORAL STEM 12/14 NECK TAPER STD
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code JDI·July 2, 2020
Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.
FDA Enforcement
Class II
·Terminated·Sunrise Medical (US) LLC·December 11, 2013
Xhibit Telemetry Receiver, Model: 96280
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·August 17, 2022
Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
FDA Enforcement
Class II
·Terminated·Natus Medical Incorporated·December 21, 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
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024