# Waismed, Ltd.

- Location (FDA's records): Rosh Ha'Ayin, IL
- FDA decisions: 7 (1998–2021): 7 510(k) clearances
- Product codes: FMI (7)
- 510(k) review time since 2016: median 92 days, against 186 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 11 (6 its own); citations of its devices by later devices: 12 (6 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Vidacare Corporation: 3 (https://510kreport.com/company/vidacare)
- Cook, Inc.: 2 (https://510kreport.com/company/cook)

## Firms that cite its devices most
- Vidacare Corporation: 4 (https://510kreport.com/company/vidacare)
- Einstein Works, LLC: 2 (https://510kreport.com/company/einstein-works)

## Its most-cited devices
- K981853: Bone Injection Gun (B.I.G.) Device (1998), cited by 5
- K142086: Nio -Intraosseous Device (2014), cited by 2
- K062940: Bone Injection Gun (B.I.G.) (2006), cited by 2
- K160805: NIO-P (2016), cited by 1
- K022415: Bone Injection Gun (B.I.G.) for Pediatrics, Model 1ST (2002), cited by 1
- K190538: NIO-I (2019), cited by 1

## Recent decisions
- K211968: NIO+ Adult (Jul 22, 2021)
- K190538: NIO-I (Oct 7, 2019)
- K160805: NIO-P (Jun 23, 2016)
- K142086: Nio -Intraosseous Device (Aug 28, 2014)
- K062940: Bone Injection Gun (B.I.G.) (Dec 22, 2006)
- K022415: Bone Injection Gun (B.I.G.) for Pediatrics, Model 1ST (Oct 11, 2002)
- K981853: Bone Injection Gun (B.I.G.) Device (Nov 17, 1998)

Source page: https://510kreport.com/company/waismed