12 results · 23ms · Sources: EU EUDAMED, US FDA

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Viz AAA

FDA 510(k)
FDA Class 2 ·Radiology

PRECISE SHP DIODE LASER

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

MEDS-3 NEUROMUSCULAR STIMULATOR

FDA 510(k)
FDA Class 2 ·Neurology

DRILL, AO T2 FEMUR 4,2X340 MM

FDA Adverse Event
Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·March 27, 2020

BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·November 30, 2021

1823260-2017-01268

FDA Adverse Event
Malfunction ·June 19, 2017

RIATA ST ACTIVE FIXATION

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011

ENDOVIVE® SAFETY PEG KIT

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KNT·July 12, 2013

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

Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

FDA Enforcement
Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026