Company ยท US
Instrumed International, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2010. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
38recalls (0 in 12 months)
10recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | 14 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 11 |
| HAX | Tong, Skull For Traction | 6 |
| HFX | Clamp, Circumcision | 2 |
| HKY | Tonometer, Manual | 2 |
| DRC | Trocar | 1 |
| DWP | Dilator, Vessel, Surgical | 1 |
| DXC | Clamp, Vascular | 1 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | 1 |
| HAE | Rongeur, Manual | 1 |
| HCZ | Forceps, Surgical, Gynecological | 1 |
| HDA | Forceps, Obstetrical | 1 |
| HDC | Tenaculum, Uterine | 1 |
| HHK | Curette, Suction, Endometrial (And Accessories) | 1 |
| MGZ | Valvulotome | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 31, 2010 | K100518 | INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 Instrumed International, Inc. | DWP |
| Apr 29, 2010 | K100517 | INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX Instrumed International, Inc. | HDA |
| Dec 3, 2009 | K092840 | INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL Instrumed International, Inc. | HCZ |
| Oct 26, 2009 | K092544 | INSTRUMED VASCULAR CLAMPS Instrumed International, Inc. | DXC |
| Aug 8, 2008 | K081651 | INSTRUMED RONGEUR Instrumed International, Inc. | HAE |
| Aug 2, 2007 | K071771 | INSTRUMED RETRACTORS Instrumed International, Inc. | GZT |
| Apr 16, 2004 | K040855 | INSTRUMED LAPAROSCOPE AND ACCESSORIES Instrumed International, Inc., DE | GEI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2014 | Instrumed International, Inc. Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentati Terminated |
HKY | None listed |
| Dec 16, 2014 | Instrumed International, Inc. Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure i Terminated |
HKY | None listed |
| Dec 16, 2014 | Instrumed International, Inc. Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names. Terminated |
HBG | None listed |
| Dec 16, 2014 | Instrumed International, Inc. CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Millennium Surgical, Medfix Internation Terminated |
HBG | None listed |
| Dec 16, 2014 | Instrumed International, Inc. Gardner-Wells wrenches are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion brand name. Terminated |
HAX | None listed |
| Dec 16, 2014 | Instrumed International, Inc. Traction tong replacement screws, non-springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold Terminated |
HAX | None listed |
| Dec 16, 2014 | Instrumed International, Inc. Titanium fixation screws, springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the Mi Terminated |
HAX | None listed |
| Dec 16, 2014 | Instrumed International, Inc. Lock nuts for titanium traction tongs are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the Car Terminated |
HAX | None listed |
| Dec 16, 2014 | Instrumed International, Inc. Replacement screw non-springloaded traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion, Terminated |
HAX | None listed |
| Dec 16, 2014 | Instrumed International, Inc. Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the Millenium Surgical, Echo Instrume Terminated |
HAX | None listed |
| Dec 16, 2014 | Instrumed International, Inc. Galt trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion brand name. Terminated |
HBG | None listed |
| Dec 16, 2014 | Instrumed International, Inc. Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix Terminated |
HBG | None listed |
| Dec 16, 2014 | Instrumed International, Inc. McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names. Terminated |
HBG | None listed |
| Dec 16, 2014 | Instrumed International, Inc. D'errico perforator drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Teleflex Medical, and CareFusion br Terminated |
HBG | None listed |
| Dec 16, 2014 | Instrumed International, Inc. McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Phoenix Instruments, Stealth Surgical, CareFusion, and Terminated |
HBG | None listed |
| Dec 16, 2014 | Instrumed International, Inc. Hudson burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, CareFusion, Boss Instrument Terminated |
HBG | None listed |
| Dec 16, 2014 | Instrumed International, Inc. Cushing burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Medfix International and Stealth Surgical brand names. Terminated |
HBG | None listed |
| Dec 16, 2014 | Instrumed International, Inc. Cushing perforating drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments, Symmetry Surgical, Medfix Internatio Terminated |
HBG | None listed |
| Dec 16, 2014 | Instrumed International, Inc. Hudson cerebellar extensions are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments brand name. Terminated |
HBG | None listed |
| Dec 16, 2014 | Instrumed International, Inc. Hudson braces are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Teleflex Medical, Boss Instruments, Symmetry Surgical, and CareFus Terminated |
HBG | None listed |
| Dec 16, 2014 | Instrumed International, Inc. Manual trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Millennium Surgical, Symmetry Surgical, Medline Industries, Care Terminated |
HBG | None listed |
| Dec 16, 2014 | Instrumed International, Inc. A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz S Terminated |
HFX | None listed |
| Dec 16, 2014 | Instrumed International, Inc. Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source on a patient's skull sold under the Boss Instruments brand name. Terminated |
HBG | None listed |
| Dec 16, 2014 | Instrumed International, Inc. An external vein stripper is an extravascular device used to remove a section of a vein sold under the Symmetry Surgical, CareFusion, Boss Instruments, Phoenix Instruments, Autobahn Surgical, Echo Ins Terminated |
MGZ | None listed |
| Dec 16, 2014 | Instrumed International, Inc. A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula sold under the Symmetry Surgical, CareFusion, and Ambler Surgical bra Terminated |
DRC | None listed |
| Dec 16, 2014 | Instrumed International, Inc. A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgic Terminated |
HFX | None listed |
| Dec 16, 2014 | Instrumed International, Inc. An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for bi Terminated |
HHK | None listed |
| Dec 16, 2014 | Instrumed International, Inc. A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion, Teleflex Medical, Symmetry Surgical brand names.
A uterine tenaculum is a hook-like Terminated |
HDC | None listed |
| Sep 30, 2014 | Instrumed International, Inc. Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use.
The instruments are intended to be used by qualified physicians to provi Terminated |
GEI | K060232 |
| Sep 30, 2014 | Instrumed International, Inc. Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use.
The instruments are intended to be used by qualified physicians to provi Terminated |
GEI | K060232 |
| Sep 30, 2014 | Instrumed International, Inc. Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use.
The instruments are intended to be used by qualified physicians to provi Terminated |
GEI | K060232 |
| Sep 30, 2014 | Instrumed International, Inc. Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use.
The instruments are intended to be used by qualified physicians to provi Terminated |
GEI | K060232 |
| Sep 30, 2014 | Instrumed International, Inc. Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use.
The instruments are intended to be used by qualified physicians to provi Terminated |
GEI | K060232 |
| Sep 30, 2014 | Instrumed International, Inc. Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use.
The instruments are intended to be used by qualified physicians to provi Terminated |
GEI | K060232 |
| Sep 30, 2014 | Instrumed International, Inc. Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use.
The instruments are intended to be used by qualified physicians to provi Terminated |
GEI | K060232 |
| Sep 30, 2014 | Instrumed International, Inc. Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use.
The instruments are intended to be used by qualified physicians to provi Terminated |
GEI | K060232 |
| Sep 30, 2014 | Instrumed International, Inc. Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use.
The instruments are intended to be used by qualified physicians to provi Terminated |
GEI | K060232 |
| Sep 30, 2014 | Instrumed International, Inc. Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use.
The instruments are intended to be used by qualified physicians to provi Terminated |
GEI | K060232 |