ClearanceBrief
Company ยท US

Sharn, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 2007. Name variants (Inc, Corp, punctuation) are merged.

4510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)

Product codes

CodeDeviceRecords
CCTApplicator (Laryngo-Tracheal), Topical Anesthesia4
BZWStethoscope, Esophageal1
CAOAirway, Esophageal (Obturator)1
CCXSupport, Patient Position1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jun 21, 2007K070596TOPICAL APPLICATOR
Sharn, Inc.
CCT
Oct 5, 1993K932305VILA-COOKE(TM) ANESTHESIA PILLOW
Sharn, Inc.
CCX
Aug 31, 1989K894032EVAC-TUBE
Sharn, Inc.
CAO
Apr 1, 1986K860558ESOPHAGEAL STETHOSCOPE
Sharn, Inc.
BZW

Latest recalls

DateFirm and productCodeLinked 510(k)
Nov 16, 2009Sharn, Inc.
Nasal Mucosal Atomizer Device without syringe, LATEX FREE For Single Patient Use Only Packaged Clean -Non-Sterile- MADE IN CANADA. REF: LTAD-N3-25, Lot 121608, packed 25 per package. REF: LTAD-N3-1
Terminated
CCTK070596
Nov 16, 2009Sharn, Inc.
Nasal Mucosal Atomizer Device with syringe, LATEX FREE For Single Patient Use Only Packaged Clean -Non-Sterile- MADE IN CANADA. REF: LTAD-N1-25, Lot 121608, packed 25 per package. REF: LTAD-N1-100,
Terminated
CCTK070596
Nov 16, 2009Sharn, Inc.
Pediatric Laryngo-Tracheal Atomizer Device without syringe, LATEX FREE For Single patient Use Only Packaged Clean -Non-Sterile-, MADE IN CANADA. REF: LTAD-PL7-25, Lot 121508, packed 25 per packag
Terminated
CCTK070596
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