11 results
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19ms
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Sources: EU EUDAMED, US FDA
SIRECON COMPACT
FDA 510(k)
FDA Class 2
·Radiology
PHARMACIA & UPJOHN COMPANY LLC
FDA registration
PHARMACIA & UPJOHN COMPANY LLC·1 product·🇺🇸 United States
REPROCESSED ELECTROSURGICAL INSTRUMENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VORTEX ACCESS SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
OPGENRA (EPTOTERMIN ALFA)
FDA Adverse Event
Other
·OLYMPUS BIOTECH·Product code MQV·April 25, 2014
CARE ASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM DE MEXICO S DE RL DE CV·Product code FNL·October 18, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC., USA·Product code LFR·October 9, 2007
GELFOAM
FDA Adverse Event
Injury
·PFIZER, INC. (DEVICE)·Product code LMF·December 26, 2018
GELFOAM
FDA Adverse Event
Malfunction
·PFIZER, INC. (DEVICE)·Product code LMF·April 17, 2018
BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 ENDO MD 41 10181 ENDO MD 43 10182 ENDO MD 45 10183 ENDO MD 47 10184 ENDO MD 49 10185 ENDO MD 51 10186 ENDO MD 53 10187 ENDO MD 55 10188 ENDO SH 38 10189 ENDO SH 41 10190 ENDO SH 43 10191 ENDO SH 45 10192 ENDO SH 47 10193 ENDO SH 49 10194 ENDO SH 51 10195 ENDO SH 53 10196 ENDO SH 55
FDA Recall
Open, Classified
·BioPro, Inc.·Product code LPH·September 9, 2025
BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 ENDO MD 41 10181 ENDO MD 43 10182 ENDO MD 45 10183 ENDO MD 47 10184 ENDO MD 49 10185 ENDO MD 51 10186 ENDO MD 53 10187 ENDO MD 55 10188 ENDO SH 38 10189 ENDO SH 41 10190 ENDO SH 43 10191 ENDO SH 45 10192 ENDO SH 47 10193 ENDO SH 49 10194 ENDO SH 51 10195 ENDO SH 53 10196 ENDO SH 55
FDA Enforcement
Class II
·Ongoing·BioPro, Inc.·October 22, 2025