15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ROUND FILTERS W/INDICATOR
FDA Adverse Event
Malfunction
·SPS MEDICAL·Product code FRG·February 28, 2014
AESCULAP STERILCONTAINER SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
PROWLER
FDA UDI
Medos International Sàrl·10886704028680·PROWLER PLUS Infusion Catheter 2.8F (0.95 mm) 2...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694060301·10mm Angled Locking Screw ID Tag
MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SMARTLENS
FDA 510(k)
FDA Class 2
·Ophthalmic
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 17, 2013
EON MINI RECHARGEABLE IPG
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·March 22, 2011
WALLFLEX ENTERAL COLONIC STENT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code MQR·June 18, 2008
20 G X 1.16 IN. (1.1 MM X 30 MM) BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
FDA Adverse Event
Injury
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·September 25, 2017
EMBOTRAP II 5X33 REVASC. DEV.
FDA Adverse Event
Malfunction
·NEURAVI LTD.·Product code NRY·October 29, 2019
PROWLER PLUS 20CM TIP, 150 CM
FDA Adverse Event
Malfunction
·CODMAN AND SHURTLEFF, INC·Product code KRA·October 29, 2019
KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE
FDA 510(k)
FDA Class 2
·Neurology
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