17 results · 24ms · Sources: EU EUDAMED, US FDA

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Lumipulse G CA15-3

FDA 510(k)
FDA Class 2 ·Immunology

Integra® Miltex®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780419426·Integra® Miltex® House Incudostapedial Joint Kn...

FUTURA

FDA 510(k)
FDA Class 2 ·Physical Medicine

HAIRMAX LASERCOMB

FDA 510(k)
FDA Class 2 ·Physical Medicine

ANKLE ARTHRODESIS NAIL, LEFT 10X150MM

FDA Adverse Event
Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 8, 2010

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 22, 2014

MAXPLUS EXTENSION SET

FDA Adverse Event
Malfunction ·CAREFUSION CORP·Product code FPA·June 3, 2013

MARTEL PRINTER FOR THE I-STAT 1 ANALYZER

FDA Adverse Event
Malfunction ·MARTEL INSTRUMENTS·Product code JJE·June 30, 2011

VANGUARD ROCC POR FEM S60 L

FDA Adverse Event
Malfunction ·BIOMET UK LTD.·Product code JWH·February 3, 2026

ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

FDA Adverse Event
Injury ·COOK INC·Product code FGE·April 25, 2019

ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

FDA Adverse Event
Injury ·COOK INC·Product code FGE·January 4, 2019

ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

FDA Adverse Event
Injury ·COOK INC·Product code FGE·February 18, 2019

ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·July 26, 2019

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

VANGUARD MONO FINNED STM TIB 71X8

FDA Adverse Event
Malfunction ·BIOMET UK LTD.·Product code JWH·August 9, 2023

VANGUARD ROCC POR FEM S60 L

FDA Adverse Event
Malfunction ·BIOMET FRANCE S.A.R.L.·Product code JWH·February 20, 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