113 results
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44ms
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Sources: EU EUDAMED, US FDA
SSK Co.,Ltd
FDA registration
SSK Co.,Ltd·2 products·🇰🇷 South Korea
Design Options Spinal Tray Material Description (Material Number): SSK HACKENSACK MEDICAL CTR 20061890 (560074), SSK SUTTER COMMUNITY HOSPITAL (560214), SSK BJC HEALTH SYSTEMS (ORIGINAL CUST) (560272), SSK CA PACIFIC MED. CTR (ORIGINAL CUST) (560327), SSK TORRANCE MEMORIAL HOSPITAL (560394), SSK SURGERY ONE 20070208 (560428), SSK LUTHERN GENERAL HOSP (ORIGINAL CUST) (560462), SSK HOAG MEMORIAL HOSPITAL (560465), SSK BUPIVACAINE TRAY 2068824 (560476), SSK KAISER FOUNDATION HOSPITAL (560497), SSK THOMAS JEFFERSON UNIV HOSP (560513), SSK OVERLAKE MEDICAL CENTER (560521), SSK CUSTOM SPINAL TRAY (560523), SSK ORLANDO REGIONAL MED CENTER (560533), SSK BON SECOURS HEALTH SYS 20115122 (560538), SSK MANATEE MEMORIAL (560572), SSK MOUNT SINAI 27GA PENCAN SPINAL TRAY (560580), SSK SHANDS TEACHING HOSP. & CLINICS, INC (560584), SSK UNIVERSITY OF COLORADO (560587), SSK P25BKG (560603), SSK P24BKG (560606), SSK S25BKG (560607), SSK MAYO CLINIC - BUPIVACAINE TRAY (560609), SSK THE MEDICAL CENTER (560613), SSK PENCIL POINT SPINAL TRAY (560619), SSK EMORY ORTHO & SPINE HOSPITAL-SPINAL (560621), SSK BSW SPINAL TRAY (560628), SSK MAYO CLINIC OB DEPT - SPINAL (560645), SSK BAPTIST HOSPITAL OF MIAMI (560646), SSK MERCY GILBERT MEDICAL CENTER (560647), SSK ST.MARY'S HOSPITAL (560648), SSK HARRIS HEALTH SYSTEM (560660), OHIO STATE U MEDICAL CTR SPINAL TRAY SSK (560667), ALBANY MEDICAL CENTER, SSK (560670), STONY BROOK HOSPITAL - SPINAL TRAY SSK (560672);
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code OFU·May 6, 2026
Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number): SSK H M C 20061890 (560074), SSK S C H (560214), SSK BJC H S (ORIGINAL CUST) (560272), SSK CA P M C (ORIGINAL CUST) (560327), SSK T M H (560394), SSK S O 20070208 (560428), SSK L G H (ORIGINAL CUST) (560462), SSK H M H (560465), SSK BUPIVACAINE TRAY 2068824 (560476), SSK K F H (560497), SSK T J U H (560513), SSK O M C (560521), SSK CUSTOM SPINAL TRAY (560523), SSK O R M C (560533), SSK B S H S 20115122 (560538), SSK M M (560572), SSK M S 27GA PENCAN SPINAL TRAY (560580), SSK S T H & C (560584), SSK U C (560587), SSK P25BKG (560603), SSK P24BKG (560606), SSK S25BKG (560607), SSK M C - BUPIVACAINE TRAY (560609), SSK T M C (560613), SSK PENCIL POINT SPINAL TRAY (560619), SSK E O & S H-SPINAL (560621), SSK BSW SPINAL TRAY (560628), SSK M C OB DEPT - SPINAL (560645), SSK B H M (560646), SSK M G M C (560647), SSK S M H (560648), SSK H H S (560660), O S U M C SPINAL TRAY SSK (560667), A M C, SSK (560670), S B H - SPINAL TRAY SSK (560672);
FDA Enforcement
Class I
·Ongoing·B Braun Medical Inc·June 10, 2026
Star Asking Medical Technology Co.,Ltd
Manufacturer
🇨🇳 China
FSK CO., LTD
FDA registration
FSK CO., LTD·1 product·🇰🇷 South Korea
NIDEK EC-5000 EXCIMER LASER SYSTEM
FDA Adverse Event
Injury
·NIDEK CO., LTD.·Product code LZS·October 11, 2013
NIDEK EC-5000 EXCIMER LASER SYSTEM
FDA Adverse Event
Injury
·NIDEK CO., LTD.·Product code LZS·October 11, 2013
NIDEK EC-5000 EXCIMER LASER SYSTEM
FDA Adverse Event
Injury
·NIDEK CO., LTD.·Product code LZS·October 11, 2013
NIDEK EC-5000 EXCIMER LASER SYSTEM
FDA Adverse Event
Injury
·NIDEK CO., LTD.·Product code LZS·October 11, 2013
NIDEK EC-5000 EXCIMER LASER SYSTEM
FDA Adverse Event
Injury
·NIDEK CO., LTD.·Product code LZS·October 11, 2013
DAILY ACTIVITY ASSIST DEVICE
FDA Adverse Event
Malfunction
·FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.·Product code ILS·July 19, 2013
NIDEK EC-5000 EXCIMER LASER SYSTEM
FDA Adverse Event
Injury
·NIDEK CO., LTD.·Product code LZS·October 11, 2013
NIDEK EC-5000 EXCIMER LASER SYSTEM
FDA Adverse Event
Injury
·NIDEK CO., LTD.·Product code LZS·October 11, 2013
CARESTREAM 2400P
FDA Adverse Event
Malfunction
·NANORAY CO., LTD.·Product code EHD·June 20, 2024
CARESTREAM 2400P
FDA Adverse Event
Malfunction
·NANORAY CO., LTD.·Product code EHD·June 20, 2024
CARESTREAM 2400P
FDA Adverse Event
Malfunction
·NANORAY CO., LTD.·Product code EHD·June 20, 2024
XTRA TRAC SHOEC, XLG
FDA Adverse Event
Injury
·O&M HALYARD, INC.·Product code FXP·September 14, 2023
SOL-MILLENNIUM
FDA Adverse Event
Malfunction
·SOL-MILLENNIUM MEDICAL INC·Product code FMF·June 6, 2025
SOL-MILLENNIUM
FDA Adverse Event
Malfunction
·SOL-MILLENNIUM MEDICAL INC·Product code FMF·June 6, 2025
TOWEL: OR BLU 80/CS
FDA Adverse Event
Malfunction
·MEDICAL ACTION INDUSTRIES·Product code PUI·August 28, 2024