12 results
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28ms
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Sources: EU EUDAMED, US FDA
BIRD TBIRD VELA VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032451·Baltic Denture System BDLoad ↓ Mw7 PLSEum2DFm B...
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668103074·DONNENFELD FEMTO SPLITTER LEFT
SMALL HEXAGONAL SCREWDRIVER SHAFT
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·December 22, 2021
MODIFICATION TO: PRONTO DRY
FDA 510(k)
FDA Class 1
·Microbiology
PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246
FDA 510(k)
FDA Class 2
·Cardiovascular
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 3, 2013
MULTI-LINK RX PIXEL CORONARY STENT SYSTEM
FDA Adverse Event
Death
·AV-TEMECULA-CT·Product code MAF·March 29, 2011
BELT CLIP PUMP CLEAR
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·August 25, 2014
LIFEPAK CR(R) PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·December 21, 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
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016