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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ADVANCE TOTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526780750·LEVAMED ACTIVE ANKLE SUP SLVR L III
Mini Sprint ®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70612231·Mini Sprint II Brackets FACE Evolution II Syste...
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0112230·Tap, 5.50mm, Cannulated, Fixed Sleeve
QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ACULUX, MODEL AX3001, AX3002
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code LOX·April 18, 2011
PLUM A+ DRIVER NEW 8
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·April 10, 2013
SETROX S 53
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·June 13, 2008
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