1,631 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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8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202
FDA Enforcement
Class II
·Terminated·Trilliant Surgical, LLC·April 8, 2020
8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202
FDA Recall
Terminated
·Trilliant Surgical, LLC·Product code HTY·November 4, 2019
Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)
FDA Enforcement
Class II
·Terminated·MEDLINE INDUSTRIES, LP - Northfield·April 20, 2022
Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)
FDA Recall
Terminated
·MEDLINE INDUSTRIES, LP Northfield·Product code JIN·March 8, 2022
Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure).
FDA Recall
Terminated
·Alere San Diego, Inc.·Product code NBC·May 22, 2012
Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA anticoagulated whole blood and plasma specimens.
FDA Recall
Terminated
·Alere San Diego, Inc.·Product code NBC·May 22, 2012
Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens.
FDA Recall
Terminated
·Alere San Diego, Inc.·Product code DAP·May 22, 2012
Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens.
FDA Recall
Terminated
·Alere San Diego, Inc.·Product code NBC·May 22, 2012
Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.
FDA Recall
Terminated
·Alere San Diego, Inc.·Product code GHH·May 22, 2012
Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
FDA Enforcement
Class II
·Terminated·Nidek Inc·July 22, 2015
Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20; The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
FDA Enforcement
Class II
·Terminated·Nidek Inc·July 22, 2015
Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
FDA Recall
Terminated
·Nidek Inc·Product code GEX·March 25, 2015
Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20; The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
FDA Recall
Terminated
·Nidek Inc·Product code GEX·March 25, 2015
CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
FDA Enforcement
Class II
·Terminated·Cytocell Ltd.·December 7, 2022
10-Panel Pipette Drug Screen, Item No. PSP-10M
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ProScreen 12 Panel Dip Card, Item No. PSD-12BUP
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ProScreen 9 Panel Cup w/Adulterants, Item No. PSCUPA-9BO300
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
DrugSmart 9 Test Cup (BUP), Item No. 60960D
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
RealityCHECK Tilt Cup 12 Panel + Adult, Item No. RC12TCA
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
THERMO FISHER 8 DRUG CASSETTE, Item No. MTPA-8MBAU
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015