13 results · 22ms · Sources: EU EUDAMED, US FDA

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MALIBU SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

REPROCESSED ATHROSCOPICS BURS

FDA 510(k)
FDA Class 2 ·Orthopedic

4.0/2.5 MM SELF-DRILLING SCHANZ SCREW

FDA 510(k)
FDA Class 2 ·Orthopedic

WAVEWRITER ALPHA PRIME 16

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 29, 2024

LINEAR 3-4

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 28, 2022

SIMULUS SEMI-RIGID ANNULOPASTY RING

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 10, 2020

VERCISE GEVIA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·April 20, 2022

PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG

FDA Adverse Event
Malfunction ·MEDELA, INC.·Product code HGX·April 19, 2013

INTRALASE FS2 LASER

FDA Adverse Event
Injury ·AMO MANUFACTURING USA, LLC.·Product code HNO·April 20, 2011

SPRINT QUATTRO SECURE

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008

NFLEX CURVED ROD 60MM-STERILE

FDA Adverse Event
Injury ·SYNTHES ELMIRA·Product code NQP·March 31, 2016

Endopath 10 mm Anvil Graspers with Ratchet Handles (product code 10AG).

FDA Recall
Terminated ·Ethicon Endo-Surgery·Product code MDM·December 15, 2004

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