16 results · 31ms · Sources: EU EUDAMED, US FDA

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NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES

FDA 510(k)
FDA Class 2 ·Cardiovascular

LIFE SCOPE PT

FDA Adverse Event
Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·December 26, 2023

LIFE SCOPE PT

FDA Adverse Event
Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·December 8, 2023

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014605883·SIEMENS 1130 3PC PAD SET 2 1/4 DELUXE W/GEL

UNKNOWN SCREW

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code PAO·February 4, 2015

NA

FDA UDI
STRYKER CORPORATION·07613327058369·Insert, Needleholder, Curved Right

UNIFIL FLOW

FDA 510(k)
FDA Class 2 ·Dental

M2376A DEVICELINK SYSTEM, MODEL M2376A

FDA 510(k)
FDA Class 2 ·Cardiovascular

ESSURE COILS

FDA Adverse Event
Injury ·CONCEPTUS, INC·Product code HHS·April 22, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 6, 2011

LIGAMAX-5MM ENDO CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code FZP·July 24, 2008

COPELAND THN SHL COCR/HA HUMS3

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code KWS·August 28, 2025

MEDISLIM

FDA Adverse Event
Injury ·MEDICREATIONS, LLC·Product code GEX·April 27, 2020

Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

FDA Enforcement
Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018