20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SAPIENS TIP CONFIRMATION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
LWT 40 LW RL (1 dwt)
FDA UDI
ARGEN CORPORATION, THE·D818112744·Gold based noble metal
5550 1/2L SYRINGE
FDA UDI
HANS RUDOLPH, INC.·00874750009947·5550B 1/2LSYR 22MM/15MM OUTLET
PRONTOSAN WOUND IRRIGATION SOLUTION
FDA 510(k)
FDA Unclassified
·Unknown
INTRAORAL LENS OPTION TO SPECTROSHADE
FDA 510(k)
FDA Class 1
·Dental
MAGELLAN
FDA Adverse Event
Malfunction
·CARDINAL HEALTH, INC.·Product code FMI·June 11, 2024
UNKNOWN NEEDLES AND SYRINGES
FDA Adverse Event
Malfunction
·CARDINAL HEALTH·Product code FMI·March 14, 2024
MAGELLAN
FDA Adverse Event
Malfunction
·CARDINAL HEALTH, INC.·Product code FMI·October 15, 2024
MAGELLAN
FDA Adverse Event
Malfunction
·CARDINAL HEALTH, INC.·Product code FMI·October 17, 2024
MAGELLAN
FDA Adverse Event
Malfunction
·CARDINAL HEALTH, INC.·Product code FMI·October 23, 2024
MAGELLAN
FDA Adverse Event
Malfunction
·CARDINAL HEALTH, INC.·Product code FMI·July 15, 2024
UNICEL® DXC 800 SYNCHRON® SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·May 14, 2013
INTACT HUMAN CHORIONIC GONADOTROPIN + THE ?-SUBUNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code DHA·June 3, 2011
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·KXBAXTER HEALTHCARE·Product code FKX·August 11, 2008
VARIABLE SELF-DRILLING SCREW DIAM. 4X14MM (2X)
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWQ·October 4, 2017
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 24, 2021
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021