48 results
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15ms
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Sources: EU EUDAMED, US FDA
intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60; IP DAB Chromogen Kit 80 ml, REF: IPK5010G80, containing DAB Buffer, Catalog Number: IPBF5009G20; DAB kit, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60 Folate Receptor alpha IHC Assay Kit, REF: IPI4006KG10, containing DAB Buffer, Catalog Number: IPBF5009G20
FDA Recall
Open, Classified
·Biocare Medical, LLC·Product code PPM·September 25, 2024
Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/A Product Description: OBM00002 OBM DAB (Digital Acquisition Box) Component: No
FDA Recall
Open, Classified
·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·Product code OMA·May 7, 2025
DAC 044 115cm, Catalog: 90760
FDA Recall
Open, Classified
·Stryker Neurovascular·Product code DQY·April 23, 2024
PDSIIVIO30IN(75CM)USP6-0(M0.7)D/AC-1
FDA Recall
Open, Classified
·Ethicon Endo Surgery, LLC·Product code NEW·March 7, 2025
PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP
FDA Recall
Open, Classified
·Ethicon Endo Surgery, LLC·Product code NEW·March 7, 2025
The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. Device dimensions and configuration are shown on the product label. A rotating hemostasis valve with side-arm adapter is provided with each catheter. The rotating hemostasis valve is typically y shaped with a female luer lock and a manual hemostasis valve. The female port allows for aspiration and contrast injections while the hemostasis valve allows direct arterial access when using other devices such as guidewires and/or interventional devices.
FDA Recall
Open, Classified
·Stryker Neurovascular·Product code DQY·April 3, 2024
ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code GKZ·March 5, 2021
ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code GKZ·March 5, 2021
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK, OPEN HEART ADULT PART 1 CDS, OPEN HEART B PACK-LF, OPEN HEART PACK, Z OPEN HEART.
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OEZ·February 21, 2025
Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K ; 2) MERCY COMBINED PACK-LF, Pack Number DYNJ0233004D ; 3) E P DRAPE PACK-LF , Pack Number DYNJ0373061J ; 4) PACEMAKER DRAPE PACK-LF , Pack Number DYNJ0406118K ; 5) FEMORAL ANGIOGRAPHY PACK, Pack Number DYNJ0618509F ; 6) EP DRAPE PACK-LF, Pack Number DYNJ22911I ; 7) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ36314J ; 8) SPLIT DRAPE , Pack Number DYNJ37265F ; 9) 4 DRAPE PROCEDURE PACK, Pack Number DYNJ39689D ; 10) DR MOTT DRAPE PACK, Pack Number DYNJ42065B ; 11) PK, EP LAB, Pack Number DYNJ43815C ; 12) MAYO STAND PACK , Pack Number DYNJ50738; 13) DAA BI-LAT, Pack Number DYNJ903538C; 14) PACEMAKER , Pack Number DYNJ903545C; 15) CSTM NEONATAL FEM DRAPE PK, Pack Number DYNJCD0114
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code KKX·April 8, 2024
18 Coated Super Tampons; Model Number: FG-TMP-REF00180000;
FDA Recall
Open, Classified
·DAYE (ANNE'S DAY LTD)
Biscuit Factory Business Complex
100 Drummond Road
London United Kingdom·Product code HEB·February 17, 2025
Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909;
FDA Recall
Open, Classified
·DAYE (ANNE'S DAY LTD)
Biscuit Factory Business Complex
100 Drummond Road
London United Kingdom·Product code HEB·February 17, 2025
Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;
FDA Recall
Open, Classified
·DAYE (ANNE'S DAY LTD)
Biscuit Factory Business Complex
100 Drummond Road
London United Kingdom·Product code HEB·February 17, 2025
Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;
FDA Recall
Open, Classified
·DAYE (ANNE'S DAY LTD)
Biscuit Factory Business Complex
100 Drummond Road
London United Kingdom·Product code HEB·February 17, 2025
Refill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909;
FDA Recall
Open, Classified
·DAYE (ANNE'S DAY LTD)
Biscuit Factory Business Complex
100 Drummond Road
London United Kingdom·Product code HEB·February 17, 2025
18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000;
FDA Recall
Open, Classified
·DAYE (ANNE'S DAY LTD)
Biscuit Factory Business Complex
100 Drummond Road
London United Kingdom·Product code HEB·February 17, 2025
Refill 36 Coated Regular Tampons; Model Number: FG-TMP-MM-REF36000000;
FDA Recall
Open, Classified
·DAYE (ANNE'S DAY LTD)
Biscuit Factory Business Complex
100 Drummond Road
London United Kingdom·Product code HEB·February 17, 2025
9 Coated Regular Tampons and 9 Nude Regular Tampons; Model Number: FG-TMP-RET09000900;
FDA Recall
Open, Classified
·DAYE (ANNE'S DAY LTD)
Biscuit Factory Business Complex
100 Drummond Road
London United Kingdom·Product code HEB·February 17, 2025
Initiation 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-IB00180018;
FDA Recall
Open, Classified
·DAYE (ANNE'S DAY LTD)
Biscuit Factory Business Complex
100 Drummond Road
London United Kingdom·Product code HEB·February 17, 2025
Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO;
FDA Recall
Open, Classified
·DAYE (ANNE'S DAY LTD)
Biscuit Factory Business Complex
100 Drummond Road
London United Kingdom·Product code HEB·February 17, 2025