11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Erisma LP Navigated Instruments
FDA 510(k)
FDA Class 2
·Neurology
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112915·CORNEAL TREPHINE BLADE7.5MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112496·BARRON VACUUM TREPHINE 7.5MM
NuVasive Thoracolumbar Plates
FDA 510(k)
FDA Class 2
·Orthopedic
V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING; V.A.C. GRANUFOAM SILVER LARGE DRESSING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
XMAX MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code ERL·October 27, 2014
CAPSURE Z
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 2, 2013
SMR REVERSE HUMERAL BODY SHORT
FDA Adverse Event
Injury
·LIMACORPORATE SPA·Product code KWS·June 13, 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
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025