16 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DUPUY S-ROM STD HIP STEM PROSTHESIS
FDA 510(k)
FDA Class 3
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526780736·LEVAMED ACTIVE ANKLE SUP SLVR L I
Mini Sprint ®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70612211·Mini Sprint II Brackets FACE Evolution II Syste...
PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MALE LATEX COMDOM WITH DOTTED SURFACE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ADVIA CENTAUR XPT TOXOPLASMA G (TOXO G) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LGD·August 4, 2017
FROSTBITE
FDA Adverse Event
Injury
·LEICA BIOSYSTEMS·Product code LEA·September 3, 2019
WHEELCHAIR COMPONENTS
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code KNN·April 16, 2013
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·September 4, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 18, 2011
PK DISSECTING FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·October 21, 2013
CONFIDA BRECKER CURVE GUIDEWIRE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code DQX·June 5, 2025
ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LGD·June 5, 2017
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018