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

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2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S

FDA 510(k)
FDA Class 2 ·Orthopedic

20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·July 12, 2019

BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·January 16, 2020

O-LAS OPHTHALMIC PHOTODISRUPTOR

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

CYTOFLEX MESH

FDA 510(k)
FDA Class 2 ·Dental

VERCISE GENUS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·February 22, 2023

MECHANICAL WALKER, ROLLATOR

FDA Adverse Event
UNKNOWN·Product code ITJ·April 29, 2013

ACCU-CHEK FLEXLINK PLUS

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·April 12, 2011

NPB290 PULSE OXIMETER

FDA Adverse Event
Death ·COVIDIEN, FORMERLY TYCO·Product code DQA·July 25, 2008

DYNESYS LIS, STABILIZING CORD, 200

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code NQP·May 2, 2019

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021