11 results
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18ms
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Sources: EU EUDAMED, US FDA
COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756349147·THORACOTOMY PACK
TROJAN NIRVANA COLLECTION LUBRICATED CONDOMS
FDA Adverse Event
Injury
·CHURCH & DWIGHT CO., INC.·Product code HIS·June 24, 2020
COMFOR-CLINER
FDA 510(k)
FDA Class 1
·Physical Medicine
MEDLINE EPIDURAL AND SPINAL NEEDLES
FDA 510(k)
FDA Class 2
·Anesthesiology
MICRUSFRAME18 15MM X 50CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·December 1, 2020
UNKNOWN DEPUY ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·January 11, 2013
ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT; ENDOVIVE LOW PROFILE BUTTON REPLACEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·November 30, 2010
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·July 2, 2014
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