64 results
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20ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Sterile Custom Packs to be used in surgical procedures.
FDA Enforcement
Class II
·Terminated·American Contract Systems·June 10, 2020
Custom Packs to be used in surgical procedures.
FDA Enforcement
Class II
·Terminated·American Contract Systems·June 10, 2020
Basic Tray, part number PSS1559(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging Box - Unilateral Frame, Galaxy UNYCO Ankle Bridging Box - Delta Frame, and Galaxy UNYCO Diaphyseal Tibia Box. Intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.
FDA Enforcement
Class II
·Terminated·Orthofix Srl·January 3, 2018
Sterile Custom Packs to be used in surgical procedures.
FDA Enforcement
Class II
·Terminated·American Contract Systems·June 10, 2020
E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
FDA Enforcement
Class I
·Terminated·E25Bio, Inc.·February 16, 2022
MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·June 24, 2020
Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use
FDA Enforcement
Class II
·Terminated·Microbiologics Inc·March 13, 2019
XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate, the sponges expand, thus increasing the dressing's capacity to absorb fluids. XGAUZE is packed in a pre-formed sterile barrier system (pouch sealed on three sides); one side is a PET/foil/PE film, and the other side is a PET/aluminum oxide/PE film. Packages are vacuum sealed and terminally sterilized via gamma radiation.
FDA Enforcement
Class II
·Terminated·Revmedx Inc·September 23, 2015
Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides Positive Expiratory Pressure (PEP) Therapy for patients who have Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems, and patients with atelectasis.
FDA Recall
Terminated
·Smiths Medical ASD Inc.·Product code BWF·December 21, 2020
Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 06/30/2022.
FDA Recall
Terminated
·Medline Industries Inc·Product code OJU·February 10, 2020
Medline Winged Sponges Presaturated W/PVP REF DYND70289 DYND70289H Expiration 06/30/2022.
FDA Recall
Terminated
·Medline Industries Inc·Product code OJU·February 10, 2020
Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153.
FDA Recall
Terminated
·Medline Industries Inc·Product code LRO·February 10, 2020
UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Product Usage: System reagent for the quantitative determination of Unsaturated Iron Binding Capacity (UIBC) in human serum and plasma on Beckman Coulter AU analyzers.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JMO·August 18, 2020
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
FDA Recall
Terminated
·Aesculap Implant Systems LLC·Product code LXH·November 18, 2020
LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms
FDA Recall
Terminated
·Microbiologics Inc·Product code JTR·February 18, 2020
QC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
FDA Recall
Terminated
·Microbiologics Inc·Product code JTR·February 18, 2020
QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Culture). KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
FDA Recall
Terminated
·Microbiologics Inc·Product code JTR·February 18, 2020
QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
FDA Recall
Terminated
·Microbiologics Inc·Product code JTR·February 18, 2020
KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pack Enterococcus faecalis derived from ATCC 51299
FDA Recall
Terminated
·Microbiologics Inc·Product code JTR·February 18, 2020