14 results · 20ms · Sources: EU EUDAMED, 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