Company ยท US
Exact Medical Manufacturing, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2023. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
18recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 12, 2023 | K222460 | Intraoperative Ultrasound Probe Cover Exact Medical Manufacturing, CN | ITX |
| Aug 13, 2021 | K211969 | EMM Ultrasonic Transducer Cover Exact Medical Manufacturing | ITX |
| Feb 14, 2013 | K121919 | SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV Exact Medical Manufacturing, Inc. | KKX |
| Jun 12, 2012 | K120045 | EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV Exact Medical Manufacturing, Inc. | FYA |
| Aug 26, 2011 | K111535 | EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER Exact Medical Manufacturing, Inc. | FYA |
| Oct 4, 2010 | K101598 | EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS) Exact Medical Manufacturing, Inc. | KKX |
| Sep 20, 2010 | K101689 | EMM EQUIPMENT COVER-POLYTHYLENE Exact Medical Manufacturing, Inc. | KKX |
| Sep 20, 2010 | K101688 | EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 Exact Medical Manufacturing, Inc. | KKX |
| Sep 3, 2010 | K101593 | EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL Exact Medical Manufacturing, Inc. | FYA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover
Item ID: 1006664 Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Probe Cover, PE, Elastic Bands, 15x244cm-6"x96"
-Ultrasonic Transducer Cover
Item ID: 1006576 Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Probe Cover 6"x48"- Ultrasonic Transducer Cover
Item ID: SH29 Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover
Item ID: SH22 Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole
Item ID: SH17 Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover
Item ID: HS2000HL Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Hays Ultrasound kit
Item ID: H1000SE Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Probe Cover, 6" x 96", PE, w 3 elastic bands-
Ultrasonic Transducer Cover
Item ID: E6443N Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover
Item ID: E6360 Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Transducer Cover 15x147cm, Kit, VIP Film
w/ Bands & EMM Gel
Item ID: E6359 Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover
Item ID: E5322N Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover
Item ID: A-AU-1002N Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. 6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band -
Ultrasonic Transducer Cover
Item ID: A-AU-10- 058N Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover
Item ID: A-AU-0980N Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. 6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands -
Ultrasonic Transducer Cover
Item ID: A-AU- 0853NA Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. 6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands
Item ID: A-AU-0852NA Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands-
Ultrasonic Transducer Cover
Item ID: A-AU-0778NA Terminated |
ITX | None listed |
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover
Bulk Non-sterile
Item ID: A-AU-0776NA Terminated |
ITX | K101689 |