14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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1.5T SCANMED PV ARRAY
FDA 510(k)
FDA Class 2
·Radiology
ES™ TROCHANTERIC NAIL, LEFT, Ø11mm x 39cm x 125°
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665014396·
MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE
FDA 510(k)
FDA Class 2
·Anesthesiology
MODEL 30 CLASSIC PNEUMATONOMETER
FDA 510(k)
FDA Class 2
·Ophthalmic
CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code KNS·March 15, 2019
NKS PM-L
FDA Adverse Event
Injury
·NAKANISHI INC. (NSK)·Product code EFB·May 26, 2015
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 22, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·February 16, 2011
EMBRACE PUMP
FDA Adverse Event
Malfunction
·Product code LZH·March 26, 2008
CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code KNS·February 4, 2019
CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code KNS·August 8, 2018
CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code KNS·August 8, 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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018