1,147 results
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10ms
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Sources: EU EUDAMED, US FDA
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 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 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
ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
11 Panel Card (OPI 300) w/Adult, Item No. 71125AA
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
1 Step 12 Panel Cup, Item No. NBCA-12M-W
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
ProScreen 12 Panel Dip Card, Item No. PSD-12BUP
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015