204 results
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17ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Product 34 consists of all product under product code: JWH and same usage: Item no: 522001700 I/B II KNEE DOMED PATELLA 522001800 I/B II KNEE DOMED PATELLA 522001900 I/B II KNEE DOMED PATELLA for use in total knee arthroplasty
FDA Recall
Terminated
·Product code JWH·January 11, 2016
I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 and 4), MGII KNEE SLF-TAP BONE ST
FDA Recall
Terminated
·Zimmer, Inc.·Product code JWH·October 11, 2013
N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297
FDA Recall
Open, Classified
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code CFN·August 30, 2022
N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
FDA Recall
Open, Classified
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code CFN·August 30, 2022
SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073
FDA Recall
Terminated
·CSL Behring GmbH Emil-von-Behring-Str. 76 Marburg Germany·Product code CHN·June 5, 2017
Product 35 consists of all product under product code: JWH and same usage: Item no: 522007300 I/B II KNEE FLUTED ROD, 1 for use in total knee arthroplasty
FDA Recall
Terminated
·Product code JWH·January 11, 2016
STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
FDA Recall
Terminated
·Advanced Sterilization Products·Product code FRC·April 22, 2013
Patient tables of CT systems with brand name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus; CT/e Lite; ProSpeed AI; ProSpeed AII; ProSpeed FI; ProSpeed FII; ProSpeed EII; CT HiSpeed Series.
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code IXR·October 21, 2004
MultiDiagnost MD4
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
LithoDiagnost
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
Diagnost 96/97 DSI
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
UroDiagnost
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
MultiDiagnost MD3
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
EasyDiagnost
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
Easy Diagnost Digital
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
OmniDiagnost
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
Diagnost 76
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particle-enhanced immunonephelometry using the BN II and BN ProSpec Systems. The determination of IgM aids in the evaluation of the patient's immune system.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CFN·January 15, 2015
SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L: REF/Product Code OQIN19, SMN 10446079 (Low); N/T Protein Control SL/M, REF/Product Code OQIO19, SMN 10446085 (Mid); N/T Protein Control SL/H, REF/Product Code OQIP19, SMN 10446089 (High);
FDA Recall
Terminated
·CSL Behring GmbH Emil-von-Behring-Str. 76 Marburg Germany·Product code CHN·June 5, 2017
N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry with BN II and BN ProSpec System. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code LPS·January 11, 2017