Instrumed International, Inc.
FDA Regulatory Profile
Instrumed International, Inc. appears in FDA public data with 38 recalls, 7 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0544-2015, Class II) was initiated on September 8, 2014. Its most recent 510(k) clearance was granted on August 31, 2010.
Summary
- Total Recalls
- 38
- 510(k) Clearances
- 7
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0544-2015 | Class II | Hudson burrs are bone cutting and drilling instruments that are used without a power source on a pat | September 8, 2014 |
| Z-0547-2015 | Class II | McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power sou | September 8, 2014 |
| Z-0545-2015 | Class II | McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power s | September 8, 2014 |
| Z-0558-2015 | Class II | Tonometers are manual devices intended to measure intraocular pressure by applying a known force on | September 8, 2014 |
| Z-0543-2015 | Class II | Cushing burrs are bone cutting and drilling instruments that are used without a power source on a pa | September 8, 2014 |
| Z-0554-2015 | Class II | Traction tong replacement screws, non-springloaded are used in traction skull tongs for traction use | September 8, 2014 |
| Z-0534-2015 | Class II | A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and | September 8, 2014 |
| Z-0542-2015 | Class II | Cushing perforating drills are bone cutting and drilling instruments that are used without a power s | September 8, 2014 |
| Z-0556-2015 | Class II | CVB distraction screws are bone cutting and drilling instruments that are used without a power sourc | September 8, 2014 |
| Z-0539-2015 | Class II | Manual trephines are bone cutting and drilling instruments that are used without a power source on a | September 8, 2014 |
| Z-0548-2015 | Class II | Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling instruments tha | September 8, 2014 |
| Z-0538-2015 | Class II | A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision | September 8, 2014 |
| Z-0541-2015 | Class II | Hudson cerebellar extensions are bone cutting and drilling instruments that are used without a power | September 8, 2014 |
| Z-0549-2015 | Class II | Galt trephines are bone cutting and drilling instruments that are used without a power source on a p | September 8, 2014 |
| Z-0535-2015 | Class II | A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facil | September 8, 2014 |
| Z-0536-2015 | Class II | An external vein stripper is an extravascular device used to remove a section of a vein sold under t | September 8, 2014 |
| Z-0551-2015 | Class II | Replacement screw non-springloaded traction tongs are skull tongs for traction used to immobilize a | September 8, 2014 |
| Z-0540-2015 | Class II | Hudson braces are bone cutting and drilling instruments that are used without a power source on a pa | September 8, 2014 |
| Z-0532-2015 | Class II | A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under | September 8, 2014 |
| Z-0559-2015 | Class II | Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocu | September 8, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K100518 | INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 | August 31, 2010 |
| K100517 | INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX | April 29, 2010 |
| K092840 | INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL | December 3, 2009 |
| K092544 | INSTRUMED VASCULAR CLAMPS | October 26, 2009 |
| K081651 | INSTRUMED RONGEUR | August 8, 2008 |
| K071771 | INSTRUMED RETRACTORS | August 2, 2007 |
| K040855 | INSTRUMED LAPAROSCOPE AND ACCESSORIES | April 16, 2004 |