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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EIUS UNICOMPARTMENTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496033769·PERSONALITY 140 SHEER, SIZE 1XXL, CAMEL, GRADUA...
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033769·Baltic Denture System BDLoad BDLoad ↓ Mm6 PLSEu...
ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES, MODEL 87
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
V-GNATHOS SUPRA
FDA 510(k)
FDA Class 2
·Dental
SMALL POSTERIOR AUGMENT GLENOID PLATE, RIGHT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·October 10, 2022
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·April 3, 2013
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 17, 2011
DEXTRUS 4137
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·April 25, 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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024