3,653 results
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37ms
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Sources: EU EUDAMED, US FDA
Criterion Tool & Die Inc DBA Criterion Precision Machining
FDA registration
Criterion Tool & Die Inc DBA Criterion Precision Machining·11 products·🇺🇸 United States
PACEL BIPOLAR PACING CATHETER
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code LDF·October 5, 2022
NANOSCOPE CONSOLE
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code GCJ·April 24, 2024
SHAVER HP, APSII, HAND CONTROL
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HWE·June 7, 2024
ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3 Calibrators Shipping or unit package: Level 1: 2 x 0.5 g; Level 2: 2 x 0.5 g; Level 3: 2 x 0.5 g; Level 4: 2 x 0.5 g -- Siemens Healthcare Diagnostics, Inc. Tarrytown, NY 10591 --- System Information: The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use. For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total Hemoglobin_3 (tHb_3 and tHb_3M) methods on ADVIA¿ Chemistry systems.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics·September 11, 2013
NANOSCOPE CONSOLE
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code GCJ·June 11, 2024
DW OUTFLOW TUBE SET W/REDEUCE TUBING
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HRX·June 6, 2024
ESSURE
FDA Adverse Event
Malfunction
·BAYER PHARMA AG·Product code HHS·September 23, 2019
ANGLED REAMER, DRIVE SHAFT
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·April 5, 2024
LAT DECUBITUS SHOULDR TRACN DEV
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code KQZ·May 15, 2024
DW ARTHROSCOPY FLUID MANAGEMENT DEV
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HRX·June 3, 2024
NANOSCOPE CONSOLE
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code GCJ·April 30, 2024
NANOSCOPE CONSOLE
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code GCJ·June 19, 2024
2.9MM BIOCOMPOSITE PUSHLOCK KIT
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code MAI·April 30, 2024
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·September 20, 2019
DW ARTHROSCOPY FLUID MANAGEMENT DEV
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HRX·June 19, 2024
FUSED LIGHT CABLE, 5.0 MM X 274CM (9.0')
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code FST·June 18, 2024
LAT DECUBITUS SHOULDR TRACN DEV
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code KQZ·April 23, 2024
2.9MM BIOCOMPOSITE PUSHLOCK KIT
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code MAI·April 26, 2024
DW ARTHROSCOPY FLUID MANAGEMENT DEV
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HRX·April 30, 2024