Exact Medical Manufacturing, Inc.
Exact Medical Manufacturing, Inc. holds FDA 510(k) medical device clearances, first cleared 2010, most recent 2013, with 18 FDA device recalls on record.
Top product codes for Exact Medical Manufacturing, Inc.
FDA recalls by Exact Medical Manufacturing, Inc.
10 most recent of 18- Z-1907-2021 — Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA
- Z-1915-2021 — Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359
- Z-1909-2021 — 6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA
- Z-1914-2021 — Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N
- Z-1919-2021 — Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL
- Z-1921-2021 — Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22
- Z-1918-2021 — Hays Ultrasound kit Item ID: H1000SE
- Z-1923-2021 — Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cover Item ID: 1006576
- Z-1922-2021 — Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29
- Z-1920-2021 — Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Exact Medical Manufacturing, Inc.
- K121919 — SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV
- K120045 — EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV
- K111535 — EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER
- K101598 — EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS)
- K101688 — EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004
- K101689 — EMM EQUIPMENT COVER-POLYTHYLENE
- K101593 — EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL
Data sourced from openFDA. This site is unofficial and independent of the FDA.