18 results
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19ms
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Sources: EU EUDAMED, US FDA
ACCUSOL DIALYSIS SOLUTION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517283030·CoRoent® Large MP, 14x9x28 4°
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704265835·
TASMIN R 4°
FDA UDI
SIGNUS Medizintechnik GmbH·04047844014523·The basic shape of the TASMIN R devices is a ho...
OPTIMUM WETTING AND REWETTING DROP
FDA 510(k)
FDA Class 2
·Ophthalmic
TRICERAM
FDA 510(k)
FDA Class 2
·Dental
MAXIFLO ULTRATHIN WITH UNITY CONTRUCTION
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 27, 2012
SAGITTAL SAW ATTACHMENT
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWE·April 8, 2013
VITALITY DS VR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
ENDOTAK DSP
FDA Adverse Event
Injury
·GUIDANT PUERTO RICO BV·Product code NVY·April 6, 2011
LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 18MM
FDA Adverse Event
Malfunction
·OBERDORF : SYNTHES PRODUKTIONS GMBH·Product code HWC·February 1, 2018
LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·February 13, 2018
LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018