Exact Medical Manufacturing, Inc.
FDA Regulatory Profile
Exact Medical Manufacturing, Inc. appears in FDA public data with 18 recalls, 9 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1907-2021, Class II) was initiated on April 29, 2021. Its most recent 510(k) clearance was granted on May 12, 2023.
Summary
- Total Recalls
- 18
- 510(k) Clearances
- 9
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1907-2021 | Class II | Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile It | April 29, 2021 |
| Z-1915-2021 | Class II | Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359 | April 29, 2021 |
| Z-1909-2021 | Class II | 6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA | April 29, 2021 |
| Z-1914-2021 | Class II | Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N | April 29, 2021 |
| Z-1918-2021 | Class II | Hays Ultrasound kit Item ID: H1000SE | April 29, 2021 |
| Z-1923-2021 | Class II | Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cover Item ID: 1006576 | April 29, 2021 |
| Z-1919-2021 | Class II | Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL | April 29, 2021 |
| Z-1920-2021 | Class II | Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17 | April 29, 2021 |
| Z-1921-2021 | Class II | Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22 | April 29, 2021 |
| Z-1910-2021 | Class II | 6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item I | April 29, 2021 |
| Z-1912-2021 | Class II | 6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Transducer Cover Item I | April 29, 2021 |
| Z-1908-2021 | Class II | Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778 | April 29, 2021 |
| Z-1913-2021 | Class II | Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N | April 29, 2021 |
| Z-1911-2021 | Class II | Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID: A-AU-0980 | April 29, 2021 |
| Z-1924-2021 | Class II | Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover Item ID: 1006664 | April 29, 2021 |
| Z-1916-2021 | Class II | Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: | April 29, 2021 |
| Z-1922-2021 | Class II | Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29 | April 29, 2021 |
| Z-1917-2021 | Class II | Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N | April 29, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K222460 | Intraoperative Ultrasound Probe Cover | May 12, 2023 |
| K211969 | EMM Ultrasonic Transducer Cover | August 13, 2021 |
| K121919 | SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV | February 14, 2013 |
| K120045 | EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV | June 12, 2012 |
| K111535 | EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER | August 26, 2011 |
| K101598 | EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONF | October 4, 2010 |
| K101688 | EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 | September 20, 2010 |
| K101689 | EMM EQUIPMENT COVER-POLYTHYLENE | September 20, 2010 |
| K101593 | EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL | September 3, 2010 |