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Sources: EU EUDAMED, US FDA
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FDA Recall
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ABL77 Cal Pack, Model Number 944-069, Lot Number 17323, SenDx Medical Inc., A Radiometer Company
FDA Recall
Terminated
·Sendx Medical Inc·Product code CHL·June 19, 2007
SenDx Medical Inc ABL80FLEX Blood Gas, pH, Electrolyte, and Metabolite System The ABL80 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, and hematocrit in whole blood. The ABL80 FLEX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
FDA Recall
Terminated
·Sendx Medical Inc·Product code CHL·January 30, 2012
ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point of care setting
FDA Recall
Terminated
·Sendx Medical Inc·Product code CHL·January 6, 2010
ABL8O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number 914863
FDA Recall
Terminated
·Sendx Medical Inc·Product code CHL·June 4, 2007
ABL80 FLEX Analyzer, Model #393-839
FDA Recall
Terminated
·Sendx Medical Inc·Product code CHL·March 27, 2007
ABL 80 CO-OX SYSTEM, software versions 1.30 and 1.31 Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI The ABL 80 CO-OX SYSTEM is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL 80 CO-OX SYSTEM is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
FDA Recall
Terminated
·Sendx Medical Inc·Product code CHL·February 20, 2009
ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System. Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) are portable, automated analyzers that measure pH, blood gases, electrolytes, glucose and oximetry (ABL80 FLEX CO-OX only) in whole blood. The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) analyzer systems are intended for use by trained technologists, nurses, physicians and therapists. They are intended for use in a laboratory environment, near patient or point-of-care setting.
FDA Recall
Terminated
·Sendx Medical Inc·Product code CHL·June 6, 2012
Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA IntelliSpace PACS are image management systems intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RE, RT, MG, SC, VL, as well as hospital/radiology information systems.
FDA Recall
Terminated
·Philips Healthcare Informatics, Inc.·Product code LLZ·October 14, 2013
Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making dilutions of samples/transport media in preparation for microbial testing of the sample. It is also used for diluting sterile reagents and microorganism preparations
FDA Recall
Open, Classified
·Edge Biologicals Inc·Product code QMC·October 2, 2023
Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
FDA Recall
Terminated
·Spacelabs Healthcare Inc·Product code MHX·February 26, 2016
Light Adaptor for Small Battery Drive and Small Battery Drive II.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HWE·June 24, 2016
Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage: The Light Adaptor for Small Battery Drive (SBD) /Small Battery Drive II (SBD II) is designed for use in traumatology and orthopedic surgery of the skeleton, i.e. drilling, reaming or cutting bone. The Adaptors (05.001.024 and 05.001.108) can be used with one of the electrical consoles belonging to the Electric Pen Drive (EPD) to operate the Small Battery Drive and Small Battery Drive II.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HWE·June 24, 2016
Johnson & Johnson BAND-AID Brand First Aid Products SECURE-FLEX Wrap (size: 2in)
FDA Recall
Terminated
·Johnson & Johnson Consumer, Inc.·Product code FQM·December 18, 2017
COACH Self-Adhering Sports Wrap (size: 2in)
FDA Recall
Terminated
·Johnson & Johnson Consumer, Inc.·Product code FQM·December 18, 2017
COACH Self-Adhering Sports Wrap (size: 3in)
FDA Recall
Terminated
·Johnson & Johnson Consumer, Inc.·Product code FQM·December 18, 2017
Johnson & Johnson BAND-AID Brand First Aid Products HURT-FREE Wrap (size: 1in)
FDA Recall
Terminated
·Johnson & Johnson Consumer, Inc.·Product code FQM·December 18, 2017
Johnson & Johnson BAND-AID Brand First Aid Products HURT-FREE Wrap (size: 2in)
FDA Recall
Terminated
·Johnson & Johnson Consumer, Inc.·Product code FQM·December 18, 2017
Johnson & Johnson BAND-AID Brand First Aid Products SECURE-FLEX Wrap (size: 3in)
FDA Recall
Terminated
·Johnson & Johnson Consumer, Inc.·Product code FQM·December 18, 2017
"***REF IWTH56***Certain EP HEALING ABUTMENT 5mm(D) X 5mm(P) X 6mm(H).*** Healing abutment*** STERILE.***Rx Only.*** Made in USA*** Implant Innovations, Inc. Global Headquarters 4555 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 342-5454 www.3i.online.com. Outside US 561-776-6700***Implant Innovations Siberica S.L., WTC Almeda Park, Ed. 1 Planta 1a Pl. De la Pau s/n 08940-Cornella de Llobregat (Barcelona) Spain. Phone: +34 934 705500. Fax +34 933 717 849. Lot Number: 602691.***" Biomet 3i healing abutments are temporary healing abutments for use in maintaining the soft tissue opening throughout the healing process of dental restoration.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NSQ·February 23, 2010
Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into an Aluminum Oxide coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed part is then placed into a coated 1073B Tyvek/film pouch and heat sealed. This pouch acts as the sterile barrier. The pouch is then labeled and placed into a carton with an IFU. The carton is then labeled and shrink wrapped. The pouch and carton labels also contain sterilization indicator dots. Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous partial arthroplasty in the affected compartment. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implanted with bone cement. The Oxford Femoral components are indicated for use in the lateral compartment for a fixed bearing application. They are intended to be implanted with bone cement
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code HRY·December 6, 2016