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