19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VPAP S-A
FDA 510(k)
FDA Class 2
·Anesthesiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517577283·CoRoent Ant TLIF PEEK, 12x12x32mm 4°
Bernafon
FDA UDI
Bernafon AG·05711584022795·MD3 NR, PS DB MONDO 3
JOBST UltraSheer
FDA UDI
BSN MEDICAL, INC.·00035664223243·USH 30-40 THD CT S NAT 1 EN FR ES
MiniSPC Button
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071152260·12F x 2.3cm MiniSPC Low Profile Suprapubic Cath...
ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EKOSONIC ENDOVASCULAR DEVICE, 135X12CM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023
EKOSONIC ENDOVASCULAR DEVICE, 135X12CM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023
EKOSONIC ENDOVASCULAR DEVICE, 106X12CM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·March 1, 2023
EKOSONIC KIT 106CM 12CM TZ
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·December 14, 2021
AMISTEM C FEMORAL STEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·March 7, 2013
ASR ACETABULAR IMPLANT 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·May 21, 2013
CRE BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KNQ·June 13, 2011
PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·August 15, 2008
EKOSONIC ENDOVASCULAR DEVICE, 106X18CM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·May 3, 2022
EKOSONIC ENDOVASCULAR DEVICE, 106X18CM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023
Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use
FDA Enforcement
Class II
·Terminated·Vital Scientific N.V.·October 23, 2019
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025