110 results · 12ms · Sources: EU EUDAMED, US FDA

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FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic

FDA Recall
Open, Classified ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·September 3, 2025

FlexLab (FLX) System. Potassium Test System. in vitro diagnostic

FDA Recall
Open, Classified ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·September 3, 2025

Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JGS·November 18, 2021

SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

FDA Recall
Open, Classified ·Cordis Corporation·Product code FGE·October 1, 2021

SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

FDA Recall
Open, Classified ·Cordis Corporation·Product code FGE·October 1, 2021

SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

FDA Recall
Open, Classified ·Cordis Corporation·Product code FGE·October 1, 2021

SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

FDA Recall
Open, Classified ·Cordis Corporation·Product code FGE·October 1, 2021

SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

FDA Recall
Open, Classified ·Cordis Corporation·Product code FGE·October 1, 2021

SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

FDA Recall
Open, Classified ·Cordis Corporation·Product code FGE·October 1, 2021

Ultrasound Transducer (M2736A), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips M2736A Avalon Smart Ultrasound Bottom Case, NFPHA9515

FDA Recall
Open, Classified ·Pacific Medical Group Inc.·Product code HGL·September 11, 2019

Ultrasound Transducer (M1356A), that may have been serviced with the following: Pacific Medical Philips M1356A Ultrasound Board, NFPH9510; Pacific Medical Philips M1356A Ultrasound Bottom Case, NFPH9515; Pacific Medical Philips M1356A Ultrasound Cable Assembly, NFPH9520; Pacific Medical Philips M1356A Ultrasound M1356A Crystal, NFPH9535

FDA Recall
Open, Classified ·Pacific Medical Group Inc.·Product code HGL·September 11, 2019

Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Version: Not Applicable Product Description: The HFD100 Head Fixation Device provides rigid skeletal fixation within the optimal imaging envelope while introducing minimal artifacts in the acquired images. There are two different assemblies for the HFD100. The standard HFD100 is equipped with a table adapter for use with either the operating room table or the angiography table. For sites with a Hill-Rom TruSystem 7500 Hybrid Neuro MR Operating Table (ORT400), the HFD100 has a split block clamp assembly (Trumpf Mount Clamp Assembly) which connects directly to the table back section. The HFD100 system is also comprised of the linkage components to mount the skull clamp to the table adapter, and the 3-pin skull clamp. The linkage system is used to position the skull clamp in the necessary position, without colliding with the magnet bore. Component: Not a component.

FDA Recall
Open, Classified ·IMRIS Imaging Inc·Product code HBL·December 8, 2025

Button-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700HAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Ultrasound Board, NFCM9510; Pacific Medical GE Corometrics Nautilus Ultrasound Bottom Case, NFCM9515, Pacific Medical GE Corometrics Nautilus Ultrasound Cable Assembly, NFCM9520; Pacific Medical GE Corometrics Nautilus Ultrasound Crystal, NFCM9535

FDA Recall
Open, Classified ·Pacific Medical Group Inc.·Product code HGL·September 11, 2019

Loop-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700LAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Ultrasound Board, NFCM9510; Pacific Medical GE Corometrics Nautilus Ultrasound Bottom Case, NFCM9515, Pacific Medical GE Corometrics Nautilus Ultrasound Cable Assembly, NFCM9520; Pacific Medical GE Corometrics Nautilus Ultrasound Crystal, NFCM9535

FDA Recall
Open, Classified ·Pacific Medical Group Inc.·Product code HGL·September 11, 2019

ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, Model Number 96-4142A, gynecological procedures

FDA Recall
Open, Classified ·Sklar Instruments·Product code HDL·December 3, 2024

DORO Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)

FDA Recall
Open, Classified ·Pro-Med Instruments Gmbh BOETZINGER STRASSE 86 Freiburg Im Breisgau Germany·Product code HBL·March 14, 2025

Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patients having ages ranging from normal weight (full term) newborn to geriatric adults in a professional use environment. Model: 6000

FDA Recall
Open, Classified ·Welch Allyn Inc·Product code FLL·July 20, 2021

FlexoStretch Model Number: 3156057 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.

FDA Recall
Open, Classified ·Hill-Rom, Inc.·Product code FSA·August 11, 2021

LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number: 3156065B (obsolete since 12JUN2020) - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.

FDA Recall
Open, Classified ·Hill-Rom, Inc.·Product code FSA·August 11, 2021

Liko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Model: 2050015

FDA Recall
Open, Classified ·Hill-Rom, Inc.·Product code FSA·December 23, 2021