18 results · 19ms · Sources: EU EUDAMED, US FDA

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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