20 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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BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT
FDA 510(k)
FDA Class 2
·Immunology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032240·Baltic Denture System BDLoad Lm6 PLSEbil2DFl A3...
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120322401·Diamond, torpedo, COOL DIAMANT, medium grit
OPTIMUM
FDA UDI
BENCO DENTAL SUPPLY CO.·00366975067005·Optimum® HP Carbide Bur Taper/Flat End Cross Cu...
Disposable Silicone Foley Catheter
FDA UDI
Guangdong Baihe Medical Technology Co., Ltd.·06938634494930·
Disposable Silicone Foley Catheter Three-way 22Fr
FDA UDI
Guangdong Baihe Medical Technology Co., Ltd.·06938634494923·
LEKON
FDA UDI
C A I INDUSTRIES CORP·00807689003304·
RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0
FDA 510(k)
FDA Class 2
·Radiology
MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
XORAN
FDA Adverse Event
Malfunction
·XORAN TECHNOLOGIES, INC.·Product code JAK·May 9, 2011
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·March 29, 2013
ORTHO PROVUE
FDA Adverse Event
Malfunction
·MICROTYPING SYSTEMS·Product code KSZ·March 29, 2011
ENDOSCOPIC MULTIFEED STAPLER - 360- ROTATION 20 TITANIUM STAPLES
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GCJ·April 18, 2008
EDWARDS INFLATION DEVICE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code MAV·October 15, 2025
EDWARDS INFLATION DEVICE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code MAV·December 19, 2025
EDWARDS INFLATION DEVICE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code MAV·August 16, 2022
ACCUVUE ADVANCE
FDA Adverse Event
Injury
·VISTAKON·Product code LPL·October 19, 2007
Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026
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