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Exact Medical Manufacturing, Inc.

FDA Regulatory Profile

Summary

Total Recalls
18
510(k) Clearances
9
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1921-2021Class IIProbe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22April 29, 2021
Z-1908-2021Class IIProbe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778April 29, 2021
Z-1915-2021Class IITransducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359April 29, 2021
Z-1922-2021Class IIProbe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29April 29, 2021
Z-1920-2021Class IIProbe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17April 29, 2021
Z-1917-2021Class IIProbe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443NApril 29, 2021
Z-1913-2021Class IIProbe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002NApril 29, 2021
Z-1919-2021Class IIHays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HLApril 29, 2021
Z-1909-2021Class II6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NAApril 29, 2021
Z-1914-2021Class IIProbe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322NApril 29, 2021
Z-1907-2021Class IIProbe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile ItApril 29, 2021
Z-1918-2021Class IIHays Ultrasound kit Item ID: H1000SEApril 29, 2021
Z-1923-2021Class IIProbe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cover Item ID: 1006576April 29, 2021
Z-1911-2021Class IIProbe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID: A-AU-0980April 29, 2021
Z-1924-2021Class IIProbe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover Item ID: 1006664April 29, 2021
Z-1910-2021Class II6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item IApril 29, 2021
Z-1912-2021Class II6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Transducer Cover Item IApril 29, 2021
Z-1916-2021Class IITransducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID:April 29, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K222460Intraoperative Ultrasound Probe CoverMay 12, 2023
K211969EMM Ultrasonic Transducer CoverAugust 13, 2021
K121919SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IVFebruary 14, 2013
K120045EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IVJune 12, 2012
K111535EMM SURGICAL GOWN - SPUNLACE WITH PE LAYERAugust 26, 2011
K101598EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFOctober 4, 2010
K101689EMM EQUIPMENT COVER-POLYTHYLENESeptember 20, 2010
K101688EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004September 20, 2010
K101593EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXLSeptember 3, 2010