39 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions Component: Not applicable
FDA Recall
Open, Classified
·Draeger, Inc.·Product code BSZ·September 9, 2025
Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower
FDA Recall
Open, Classified
·Draeger Medical Systems, Inc.·Product code MHX·April 5, 2023
Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network,
FDA Recall
Open, Classified
·Draeger Medical Systems, Inc.·Product code MHX·April 5, 2023
Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Ost Str. 4-10 Norderstedt Germany·Product code HTW·February 11, 2026
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Ost Str. 4-10 Norderstedt Germany·Product code KRO·January 12, 2026
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Ost Str. 4-10 Norderstedt Germany·Product code HTW·February 11, 2026
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Ost Str. 4-10 Norderstedt Germany·Product code KRO·January 12, 2026
Endo-Model Replacement Plateau; Item Number: 15-0027/16;
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Ost Str. 4-10 Norderstedt Germany·Product code KRO·January 12, 2026
Endo-Model Replacement Plateau; Item Number: 15-8521/09;
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Ost Str. 4-10 Norderstedt Germany·Product code KRO·January 12, 2026
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Ost Str. 4-10 Norderstedt Germany·Product code KRO·January 12, 2026
Endo-Model Replacement Plateau; Item Number: 15-0027/12;
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Ost Str. 4-10 Norderstedt Germany·Product code KRO·January 12, 2026
Endo-Model Replacement Plateau; Item Number: 15-2835/12;
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Ost Str. 4-10 Norderstedt Germany·Product code KRO·January 12, 2026
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Ost Str. 4-10 Norderstedt Germany·Product code KRO·January 12, 2026
Endo-Model Replacement Plateau; Item Number: 15-2836/11;
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Ost Str. 4-10 Norderstedt Germany·Product code KRO·January 12, 2026
Endo-Model Replacement Plateau; Item Number: 15-8030/12;
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Ost Str. 4-10 Norderstedt Germany·Product code KRO·January 12, 2026
Endo-Model Replacement Plateau; Item Number: 15-8521/15;
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Ost Str. 4-10 Norderstedt Germany·Product code KRO·January 12, 2026
Endo-Model Replacement Plateau; Item Number: 15-0027/15;
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Ost Str. 4-10 Norderstedt Germany·Product code KRO·January 12, 2026
Endo-Model Replacement Plateau; Item Number: 15-8521/11;
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Ost Str. 4-10 Norderstedt Germany·Product code KRO·January 12, 2026
Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS10411A Nasal Endoscopy Pack AMS10710A Ultrasound Tray w/PDI AMS11941 Total Knee Pack AMS12138B Eye Pack AMS12278B Body Pack AMS12341A Hassan Pack AMS12341B Hassan Pack AMS12343A Meldrum Pack AMS12359B Neuro Pack AMS12520 Total Hip Pack AMS12608 Extremity Pack AMS12610 Shoulder Pack AMS12636 Dr. Thompson Pack AMS12689A Custom Pack AMS12753 Breast Pack AMS12754 Abdominoplasty Pack AMS12769 Minor Pack AMS12926 Shoulder Pack AMS12927 Retina Pack AMS13428 Hand Pack AMS2120D Plastics Tray AMS2890(B Basic Biopsy Tray AMS3824(A Myelogram Tray - RX AMS4022F Lami Pack AMS4371C Lasik Eye Pack AMS4372 Plastic Eye Pack AMS4599(C Spine Pack AMS4670B Upper Extremity Pack AMS4766C Shoulder Arthroscopy Pack AMS4952A Vitrectomy Pack - RX AMS5697A EVLT Pack AMS5819B Ortho Major Pack AMS5887A CARS Pack AMS6112A Minor Extremity Pack AMS6112B Minor Extremity Pack AMS6160C Hip Pack AMS6277A Procurement Bundle - Pack A/B/C AMS6728A Breast Pack AMS7463B Retrieval Pack AMS7971 TVOR Pack AMS8094 Plastics Eye Pack AMS8664B Spinal Pack AMS8989 Hysteroscopy Pack AMS9118 Retrieval Pack AMS9197 Arthroscopy Pack AMS9435 Foot Pack AMS9487A Toy Hip Pack AMS9487B Total Hip Pack CMP1018G Cataract Kit - Dr. Wright PSS1838B Medical Imaging Kit VPP1020A Custom Dental Pack VPP1023B OR Implant Bundle Pack WAL1207C Minor Pack
FDA Recall
Open, Classified
·Windstone Medical Packaging, Inc.·Product code KDD·November 1, 2022