ClearanceBrief
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

CodeDeviceRecords
HBGDrills, Burrs, Trephines & Accessories (Manual)14
GEIElectrosurgical, Cutting & Coagulation & Accessories11
HAXTong, Skull For Traction6
HFXClamp, Circumcision2
HKYTonometer, Manual2
DRCTrocar1
DWPDilator, Vessel, Surgical1
DXCClamp, Vascular1
GZTRetractor, Self-Retaining, For Neurosurgery1
HAERongeur, Manual1
HCZForceps, Surgical, Gynecological1
HDAForceps, Obstetrical1
HDCTenaculum, Uterine1
HHKCurette, Suction, Endometrial (And Accessories)1
MGZValvulotome1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Aug 31, 2010K100518INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054
Instrumed International, Inc.
DWP
Apr 29, 2010K100517INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX
Instrumed International, Inc.
HDA
Dec 3, 2009K092840INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL
Instrumed International, Inc.
HCZ
Oct 26, 2009K092544INSTRUMED VASCULAR CLAMPS
Instrumed International, Inc.
DXC
Aug 8, 2008K081651INSTRUMED RONGEUR
Instrumed International, Inc.
HAE
Aug 2, 2007K071771INSTRUMED RETRACTORS
Instrumed International, Inc.
GZT
Apr 16, 2004K040855INSTRUMED LAPAROSCOPE AND ACCESSORIES
Instrumed International, Inc., DE
GEI

Latest recalls

DateFirm and productCodeLinked 510(k)
Dec 16, 2014Instrumed 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
HKYNone listed
Dec 16, 2014Instrumed 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
HKYNone listed
Dec 16, 2014Instrumed 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
HBGNone listed
Dec 16, 2014Instrumed 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
HBGNone listed
Dec 16, 2014Instrumed 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
HAXNone listed
Dec 16, 2014Instrumed 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
HAXNone listed
Dec 16, 2014Instrumed 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
HAXNone listed
Dec 16, 2014Instrumed 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
HAXNone listed
Dec 16, 2014Instrumed 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
HAXNone listed
Dec 16, 2014Instrumed 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
HAXNone listed
Dec 16, 2014Instrumed 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
HBGNone listed
Dec 16, 2014Instrumed 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
HBGNone listed
Dec 16, 2014Instrumed 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
HBGNone listed
Dec 16, 2014Instrumed 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
HBGNone listed
Dec 16, 2014Instrumed 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
HBGNone listed
Dec 16, 2014Instrumed 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
HBGNone listed
Dec 16, 2014Instrumed 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
HBGNone listed
Dec 16, 2014Instrumed 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
HBGNone listed
Dec 16, 2014Instrumed 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
HBGNone listed
Dec 16, 2014Instrumed 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
HBGNone listed
Dec 16, 2014Instrumed 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
HBGNone listed
Dec 16, 2014Instrumed 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
HFXNone listed
Dec 16, 2014Instrumed 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
HBGNone listed
Dec 16, 2014Instrumed 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
MGZNone listed
Dec 16, 2014Instrumed 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
DRCNone listed
Dec 16, 2014Instrumed 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
HFXNone listed
Dec 16, 2014Instrumed 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
HHKNone listed
Dec 16, 2014Instrumed 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
HDCNone listed
Sep 30, 2014Instrumed 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
GEIK060232
Sep 30, 2014Instrumed 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
GEIK060232
Sep 30, 2014Instrumed 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
GEIK060232
Sep 30, 2014Instrumed 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
GEIK060232
Sep 30, 2014Instrumed 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
GEIK060232
Sep 30, 2014Instrumed 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
GEIK060232
Sep 30, 2014Instrumed 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
GEIK060232
Sep 30, 2014Instrumed 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
GEIK060232
Sep 30, 2014Instrumed 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
GEIK060232
Sep 30, 2014Instrumed 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
GEIK060232
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