# Exact Medical Manufacturing, Inc.

- Location (FDA's records): Buffalo, NY
- FDA decisions: 9 (2010–2023): 9 510(k) clearances
- Names in FDA's records: Exact Medical Manufacturing, Inc. (7); Exact Medical Manufacturing (2)
- Product codes: KKX (4), FYA (3), ITX (2)
- Predicates its devices cite: 9 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Primeline Medical Products, Inc.: 2 (https://510kreport.com/company/primeline-medical-products)
- Medline Industries, Inc.: 2 (https://510kreport.com/company/medline-industries)
- Kimberly-Clark Corp.: 2 (https://510kreport.com/company/kimberly-clark)
- Medxpress.Pro: 1 (https://510kreport.com/company/medxpress-pro)
- CIVCO Medical Instruments Co., Inc.: 1 (https://510kreport.com/company/civco-medical-instruments)
- Allegiance Healthcare Corp.: 1 (https://510kreport.com/company/allegiance-healthcare)

## Recent decisions
- K222460: Intraoperative Ultrasound Probe Cover (May 12, 2023)
- K211969: EMM Ultrasonic Transducer Cover (Aug 13, 2021)
- K121919: Surgical Drape with Aami Liquid Barrier Level IV (Feb 14, 2013)
- K120045: Emm High Performance Surgical Gown with Aami Liquid Barrier Level IV (Jun 12, 2012)
- K111535: Emm Surgical Gown - Spunlace with PE Layer (Aug 26, 2011)
- K101598: Emm Surgical Drape SMS W/PE Sides Model 13-005 (with Minor Dimensional Variations for Alternate Configurations) (Oct 4, 2010)
- K101688: Emm Surgical Drape-Spunlace W/PE Sides, Model 13-004 (Sep 20, 2010)
- K101689: Emm Equipment Cover-Polythylene (Sep 20, 2010)

Source page: https://510kreport.com/company/exact-medical-manufacturing