11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FLOSIMPLE ARTHROSCOPY PUMP A120
FDA 510(k)
FDA Class 2
·Orthopedic
nSpire Health
FDA UDI
NSPIRE HEALTH, INC.·00852417003118·Bronchial Challenge Kit, Disposable (single pat...
OCTRODE LEAD KIT, 90CM LENGTH
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 29, 2019
MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY
FDA 510(k)
FDA Class 2
·Neurology
INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
PENUMA IMPLANT
FDA Adverse Event
Injury
·NATIONAL MEDICAL DEVICES INC.·Product code MIB·March 1, 2018
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 16, 2013
RESOLUTION CLIP DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MND·June 18, 2008
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
WARSAW ORTHOPEDIC, INC.·Product code LXH·April 19, 2011
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015