11 results
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28ms
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Sources: EU EUDAMED, US FDA
A/C ENZYMATIC HOMOCYSTEINE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Utility Traction Hook
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746144257·DB LINGUAL UT HOOK FLAT PAD 10/PK
Life Instruments
FDA UDI
Life Instrument Corporation·M930703075400·Bakersfield Custom Tube Holder
IMMUNETICS C6 LYME ELISA KIT
FDA 510(k)
FDA Class 2
·Microbiology
QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ASAHI GUIDE WIRE
FDA Adverse Event
Injury
·AV-ASAHI·Product code DQX·April 2, 2013
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·August 22, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 22, 2011
MITRACLIP CLIP DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR·Product code NKM·May 4, 2020
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018