FDA Device Intelligence
Home › Karl Schumacher Dental, LLC › Karl Schumacher

Karl Schumacher

Karl Schumacher Dental, LLC · Model BCH0035 · UDI-DI 00842517105638

EMI
4
510(k) clearances
0
Adverse events
4
Recalls
148
Facilities

Description

Buser Bone Harvesting Chisel #35 3mm / 5mm Blades

Recalls

DateFirmReason
2021-04-26Meta C.G.M. SpaSterility issues; single use devices labeled as sterile may not have been adequately sterilized
2021-04-26Meta C.G.M. SpaSterility issues; single use devices labeled as sterile may not have been adequately sterilized
2021-04-26Meta C.G.M. SpaSterility issues; single use devices labeled as sterile may not have been adequately sterilized
2021-04-26Meta C.G.M. SpaSterility issues; single use devices labeled as sterile may not have been adequately sterilized

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.