14 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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MEDI-HEAT INFANT HEEL WARMER
FDA 510(k)
FDA Class 1
·Physical Medicine
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950029808·MIRROR INTRAORAL BUCCAL #5 ADULT WIDE CHROMIUM ...
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032989·Baltic Denture System BDLoad ↓ Mm6 PLSEum2DFm C...
NGB-008 Needle-guided Bracket/STEEL
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904018577·
PROCLUDE
FDA 510(k)
FDA Class 1
·Dental
DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070
FDA 510(k)
FDA Class 2
·Cardiovascular
UNK
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HRS·April 6, 2026
UNK
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HRS·April 6, 2026
FLOGARD
FDA Adverse Event
Malfunction
·SHARP CORPORATION OSAKA JAPAN·Product code FRN·April 3, 2013
PRECISION XTRA
FDA Adverse Event
Death
·Product code NBW·March 29, 2011
MORPHEOUS CT PICC
FDA Adverse Event
Injury
·ANGIO-DYNAMICS·Product code LJS·April 21, 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
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024