11 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CONTOUR TRANSTAR CURVED CUTTER STAPLER SET
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Premier Barbed Broaches
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6919053631·BROACH BARBD 25 PH BX 144
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809843149·FOR MEN 30-40 MM HG KNEE HIGH OPEN TOE EXTRA LA...
SMARTWAVE IF 2000
FDA 510(k)
FDA Class 2
·Neurology
EFILM VIDEO
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 6, 2025
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 1, 2011
DEEP BRAIN STIMULATION LEAD
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·May 23, 2008
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
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