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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ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL
FDA 510(k)
FDA Class 2
·Ophthalmic
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809845464·FOR MEN 20-30 MM HG KNEE HIGH CLOSED TOE EXTRA ...
ECG
FDA UDI
Zoll Medical Corporation·00847946021818·12 LEAD ECG LIMB LEAD, 10FT BLACK
O-PERM 30
FDA 510(k)
FDA Class 2
·Ophthalmic
CLEARFIL CORE NEW BOND
FDA 510(k)
FDA Class 2
·Dental
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 11, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 2, 2014
PROVISC
FDA Adverse Event
Malfunction
·ALCON - BELGIUM / S.A. ALCON-COUVREUR N.V.·Product code LZP·April 23, 2008
BD PRN LUER SLIP ADAPTER
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FPA·December 2, 2020
SYNERGY VERSITREL
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LGW·November 17, 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