Sarstedt, Inc.
Medical device manufacturer in Nuembrecht, DE.
7510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K222801 | Safety LancetFMK · Traditional | 01/25/2023SE |
| K051019 | Safety NeedleJKA · Traditional | 07/25/2005SE |
| K032150 | Safety-MultiflyFPA · Traditional | 09/12/2003SE |
| K031359 | S-Monovette Edta K2-GELPJE · Traditional | 09/12/2003SE |
| K024237 | Urine Monovette Boric AcidJSM · Traditional | 04/14/2003SE |
| K003382 | Sarstedt Needle ProtectorFMI · Traditional | 03/30/2001SE |
| K913622 | HemoplusKHE · Traditional | 01/31/1992SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0114-2009 | Safety Lancet for capillary blood sampling, 1.6 mm x 28G, Mini, Sarstedt. (Blood lancet)The product from this lot may not retract the lancet into the safe position inside the lancet body after the… | 08/27/2008Terminated |