19 results · 23ms · Sources: EU EUDAMED, 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