12 results
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20ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes to aid in diagnosis by means of color variation.
FDA Recall
Terminated
·Zeiss, Carl Inc·Product code IBJ·May 28, 2013
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
FDA Recall
Open, Classified
·Aesculap AG Am Aesculap-Platz 1 Tuttlingen Germany·Product code HBB·August 18, 2025
AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
FDA Recall
Open, Classified
·Aesculap AG Am Aesculap-Platz 1 Tuttlingen Germany·Product code HBB·August 18, 2025
Angiotech***HSG Procedure Tray 7Fr***1 - 18ga x 1-1/2" Needle; 1 - Fenestrated Drape; 1- 20cc Syringe L/L; 1 - Povidone-Iodine Ointment (1g); 2 - Povidone-Iodine Solution (1oz); 1 - Sanitary Napkin; 2 - Sponge Sticks (6"); 1 - Sound Dilator; 1 - Autobag; 1 - Lubricating Jelly; 2 - Cotton Tipped Swab (8"); 1 Extension Tubing (30"); 2 - 3"x3" Sponges (12-Ply); 1 - Vaginal Speculum; 1 - HSG Catheter (7Fr); 1 - Fixed Volume Syringe - 3cc; 1 - CSR Wrap***Catalog Number: 660007000***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. HSG Catheters are intended for use in the injection of contrast material in the examination of the uterus and fallopian tubes.
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code OHR·December 22, 2010
Angiotech***HSG Procedure Tray 5Fr***1 - 18ga x 1-1/2" Needle; 1 - Fenestrated Drape; 1- 20cc Syringe L/L; 1 - Povidone-Iodine Ointment (1g); 2 - Povidone-Iodine Solution (1oz); 1 - Sanitary Napkin; 2 - Sponge Sticks (6"); 1 - Sound Dilator; 1 - Autobag; 1 - Lubricating Jelly; 2 - Cotton Tipped Swab (8"); 1 Extension Tubing (30"); 2 - 3"x3" Sponges (12-Ply); 1 - Vaginal Speculum; 1 - HSG Catheter (5Fr); 1 - Fixed Volume Syringe - 2cc; 1 - CSR Wrap (30"x30")***Catalog Number: 660005000***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. HSG Catheters are intended for use in the injection of contrast material in the examination of the uterus and fallopian tubes.
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code OHR·December 22, 2010
One Step P in vitro diagnostic test REF: 8194
FDA Recall
Open, Classified
·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code JIR·April 2, 2026
One Step pH in vitro diagnostic test REF: 31I4P
FDA Recall
Open, Classified
·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code CEN·April 2, 2026
QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
FDA Recall
Open, Classified
·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code CHH·April 2, 2026
Uric Acid in vitro diagnostic test REF: 31H0P
FDA Recall
Open, Classified
·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code KNK·April 2, 2026
One Step UTI in vitro diagnostic test REF: 3374
FDA Recall
Open, Classified
·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code LJX·April 2, 2026
One Step 10A in vitro diagnostic test
FDA Recall
Open, Classified
·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code MVO·April 2, 2026
One Step K in vitro diagnostic test REF: 81A4
FDA Recall
Open, Classified
·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code JIN·April 2, 2026