19 results
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70ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA
FDA Enforcement
Class II
·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021
Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N
FDA Enforcement
Class II
·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021
Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA
FDA Enforcement
Class II
·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021
Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359
FDA Enforcement
Class II
·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021
Hays Ultrasound kit Item ID: H1000SE
FDA Enforcement
Class II
·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021
Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cover Item ID: 1006576
FDA Enforcement
Class II
·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021
Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL
FDA Enforcement
Class II
·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021
Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29
FDA Enforcement
Class II
·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021
Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22
FDA Enforcement
Class II
·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021
Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17
FDA Enforcement
Class II
·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021
6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU- 0853NA
FDA Enforcement
Class II
·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021
6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Transducer Cover Item ID: A-AU-10- 058N
FDA Enforcement
Class II
·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021
Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N
FDA Enforcement
Class II
·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021
Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NA
FDA Enforcement
Class II
·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021
Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N
FDA Enforcement
Class II
·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021
Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID: A-AU-0980N
FDA Enforcement
Class II
·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021
Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover Item ID: 1006664
FDA Enforcement
Class II
·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021
Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360
FDA Enforcement
Class II
·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021
DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis; Product Number D76004 (4x12 mL bottles) consists of: 2x12mL Positive controls [and] 2x12mL Negative controls; Manufactured for ARKRAY USA, Inc.; Minneapolis, MN 55439 Diascreen liquid urine control is a synthetic control designed to react with commercial urine dipsticks to register listed responses on color reagent pads. It is intended for use in a clinical laboratory as a urine control for qualitative procedures used in chemical determinations. The control is intended to be used exactly as if it were a patient sample to assist in the assessment of the listed analytical procedures.
FDA Enforcement
Class II
·Terminated·Assuramed·September 25, 2013