11 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RUSCH GUIDED CHOLANGIOGRAPHY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HairCheck-DT (Cocaine)
FDA UDI
Quest Diagnostics·00868586000209·HairCheck-DT (Cocaine) is an ELISA test kit use...
TAPER-FIT TOTAL HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML
FDA 510(k)
FDA Class 2
·General Hospital
ACCESS
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - AIBONITO·Product code FPA·March 27, 2013
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·March 18, 2011
CELL-DYN WBC REAGENT A
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·April 1, 2008
Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
Strep A Twist Rapid Test Cassette (K023766), IST-502T Twist Cassettes. Brand Name (Catalog Number): ACON Rapid Device Strep A Twist (IST-502T); CONSULT Diagnostics Strep A Twist, PSS (5005); Medi-Lab Performance Strep A Test-Twist, McKesson (32-502T); MooreBrand Strep A Twist Cassette, Moore (82793); and SP Strep A Rapid Twist Cassette Test, Cardinal Health (B1077-29). Type of Packaging (ie. box, plastic bag): Individually pouched devices (number of tests per kit varies from 5 to 50), the kits also include: disposable extraction test tubes, dropper tips, sterile swabs, 1 vial Strep A reagent A (10 mL): 2M Sodium Nitrite, 1 vial Strep A reagent B (10 mL): 0.4M Acetic Acid, 1 vial Strep A positive control (1 mL): Nonviable Strep A; 0.09% NaN3, 1 vial Strep A negative control (1 mL): Nonviable Strep C; 0.09% NaN3 in a labeled kit box. The Strep A Rapid Test Cassette and Twist devices are qualitative, lateral flow immunoassays for the detection of Strep A carbohydrate antigen in a throat swab, providing results within 5 minutes. The tests utilize antibodies specific for whole cell Lancefield Group A Streptococcus to selectively detect Strep A antigen in a throat swab specimen. The Cassette device uses a drop-wise application method while the Twist device has an onboard well to extract the throat swab specimen. The Strep A Rapid Test Devices are rapid chromatographic immunoassays for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection. This test is indicated for professional and point of care use only.
FDA Recall
Terminated
·Alere San Diego·Product code GTY·September 1, 2011
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
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