12 results
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19ms
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Sources: EU EUDAMED, US FDA
RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R
FDA 510(k)
FDA Class 2
·Physical Medicine
LEONE SPA
FDA UDI
LEONE SPA·08033707065777·INTRAORAL ELASTICS 6,5 oz 1/8" brown
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450210345·
INFINION 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 7, 2020
OLYMPIC WARM-UP
FDA 510(k)
FDA Class 2
·Physical Medicine
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 17, 2025
PRONTO SPOT CHECK PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·July 9, 2018
ACCUTORR V MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code DXN·April 30, 2013
OT VERIO PRO PLUS METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 16, 2014
ACCU-CHEK FLEXLINK PLUS INFUSION SET
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·May 11, 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