19 results · 31ms · Sources: EU EUDAMED, US FDA

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INTRAcel RF Microneedle System

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

CoRoent

FDA UDI
Nuvasive, Inc.·00887517567635·CoRoent Ant TLIF PEEK, 8x13x28mm 4°

LAMINOPLASY PLATING SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

PIEZOSURGERY MEDICAL

FDA 510(k)
FDA Class 2 ·Orthopedic

OPTICROSS HD

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·March 28, 2025

OPTICROSS? HD

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·July 7, 2025

OPTICROSS? HD

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·July 22, 2025

OPTICROSS? HD

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·February 11, 2025

OPTICROSS? HD

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·April 3, 2025

OPTICROSS? HD

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·December 11, 2025

OPTICROSS? HD

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·September 16, 2025

OPTICROSS? HD

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·January 13, 2026

RESERVOIR 3ML

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·June 21, 2013

ACCU-CHEK MOBILE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 28, 2011

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 17, 2014

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

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

OPTICROSS? HD

FDA Adverse Event
Death ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·May 22, 2025

OPTICROSS? HD

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·February 26, 2025