Exact Medical Manufacturing, Inc.
Lancaster, NY, US
EXACT MEDICAL MANUFACTURING, INC. appears in FDA device records in Lancaster, NY. FDA records list 9 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 18 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Exact Medical Manufacturing, Inc. between 2010 and 2023. The busiest year on record is 2010, with 4. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 4 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K222460 | Intraoperative Ultrasound Probe Cover | ITX | Substantially Equivalent | |
| K211969 | EMM Ultrasonic Transducer Cover | ITX | Substantially Equivalent | |
| K121919 | SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV | KKX | Substantially Equivalent | |
| K120045 | EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV | FYA | Substantially Equivalent | |
| K111535 | EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER | FYA | Substantially Equivalent | |
| K101598 | EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS) | KKX | Substantially Equivalent | |
| K101689 | EMM EQUIPMENT COVER-POLYTHYLENE | KKX | Substantially Equivalent | |
| K101688 | EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 | KKX | Substantially Equivalent | |
| K101593 | EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL | FYA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008011779 | 3008011779 | EXACT MEDICAL MANUFACTURING, INC. | 4917 William Street - Suite C, Lancaster, NY 14086 US | 2026 | No device listings on this registration |
| 3013443304 | 3013443304 | EXACT MEDICAL MANUFACTURING, INC. | 21# Qingjiang Road, Changzhou Jiangsu 213022 CN | 2026 | and 7 more, listed in full below |
| 3018781093 | 3018781093 | EXACT MEDICAL MANUFACTURING, INC. | No. 101 Huashan Road, Changzhou Jiangsu 213032 CN | 2026 | and 7 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LYUAccessory, Surgical Apparel
- QJFAutofluorescence Imaging Adjunct Tool For Wounds
- KYRBag, Ice
- FAQBag, Urine Collection, Leg, For External Use, Sterile
- LWHCounter, Sponge, Surgical
- KKXDrape, Surgical, Antimicrobial
- PUIDrape, Surgical, Exempt
- FYAGown, Surgical
- MDMInstrument, Manual, Surgical, General Use
- KDDKit, Surgical Instrument, Disposable
- KPYShield, Protective, Personnel
- KYZSyringe, Irrigating (Non Dental)
- GAXTourniquet, Nonpneumatic
- ITXTransducer, Ultrasonic, Diagnostic
- GAZTubing, Noninvasive
- QCRWound Autofluorescence Imaging Device
- FRGWrap, Sterilization
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1924-2021 | Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover Item ID: 1006664 | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Terminated | |
| Z-1923-2021 | Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cover Item ID: 1006576 | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Terminated | |
| Z-1922-2021 | Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29 | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Terminated | |
| Z-1921-2021 | Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22 | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Terminated | |
| Z-1920-2021 | Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17 | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Terminated | |
| Z-1919-2021 | Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Terminated | |
| Z-1918-2021 | Hays Ultrasound kit Item ID: H1000SE | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Terminated | |
| Z-1917-2021 | Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Terminated | |
| Z-1916-2021 | Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360 | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Terminated | |
| Z-1915-2021 | Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359 | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Terminated | |
| Z-1914-2021 | Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Terminated | |
| Z-1913-2021 | Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Terminated | |
| Z-1912-2021 | 6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Transducer Cover Item ID: A-AU-10- 058N | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Terminated | |
| Z-1911-2021 | Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID: A-AU-0980N | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Terminated | |
| Z-1910-2021 | 6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU- 0853NA | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Terminated | |
| Z-1909-2021 | 6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Terminated | |
| Z-1908-2021 | Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NA | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Terminated | |
| 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 | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain