14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OSTEOMED HAND PLATE AND SCREW FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MONOJECT
FDA Adverse Event
Malfunction
·JIANGSU CAINA MEDICAL CO., LTD·Product code PNR·April 14, 2024
CARDINAL HEALTH
FDA Adverse Event
Malfunction
·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 12, 2024
CARDINAL
FDA Adverse Event
Malfunction
·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 12, 2024
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·October 21, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
CLINITRON RITEHITE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code INX·June 13, 2013
RINGLOC-X E1 H/W 56/32MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·April 11, 2025
AEQUALIS STEM FOR FRACTURE D.6.5 HA-COATED
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·January 5, 2026
CARDINAL HEALTH
FDA Adverse Event
Malfunction
·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 12, 2024
Alinity m System, Part No. 08N53-002
FDA Enforcement
Class II
·Terminated·Abbott Molecular, Inc.·January 12, 2022
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022