13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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