20 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Protrieve Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220415150·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220415000·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220415070·
ELMED
FDA UDI
ELMED INCORPORATED·00842180167124·LAPAROSCOPIC PORT CLOSURE GUIDE CONE, 15MM DIA....
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365117244·
CRYO-TOUCH III
FDA 510(k)
FDA Class 2
·Neurology
VirtueRF
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DRE·April 6, 2023
SPECTRUM IQ INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·March 23, 2022
SPECTRUM IQ INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 13, 2022
SPECTRUM IQ INFUSION PUMP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code FRN·May 25, 2022
PROWLER SELECT MICROCATHETERS
FDA Adverse Event
Malfunction
·CORDIS NEUROVASCUALR, INC.·Product code KRA·October 31, 2008
ENDOPATH** XCEL* TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·August 23, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
SPECTRUM IQ INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 16, 2022
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MECTACER BIOLOX OPTION HEADS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 7, 2025
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 25, 2023
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025