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Instrumed International, Inc.

38 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus recall (Z-0532-2015)Instrumed International, Inc.2014-12-16
An endometrial suction curette is a device used to remove material from the uterus and fro recall (Z-0533-2015)Instrumed International, Inc.2014-12-16
A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce recall (Z-0534-2015)Instrumed International, Inc.2014-12-16
A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chambe recall (Z-0535-2015)Instrumed International, Inc.2014-12-16
An external vein stripper is an extravascular device used to remove a section of a vein so recall (Z-0536-2015)Instrumed International, Inc.2014-12-16
Manual bunnell cranial drills are bone cutting and drilling instruments that are used with recall (Z-0537-2015)Instrumed International, Inc.2014-12-16
A circumcision clamp is an instrument used to compress the foreskin of the penis during ci recall (Z-0538-2015)Instrumed International, Inc.2014-12-16
Manual trephines are bone cutting and drilling instruments that are used without a power s recall (Z-0539-2015)Instrumed International, Inc.2014-12-16
Hudson braces are bone cutting and drilling instruments that are used without a power sour recall (Z-0540-2015)Instrumed International, Inc.2014-12-16
Hudson cerebellar extensions are bone cutting and drilling instruments that are used witho recall (Z-0541-2015)Instrumed International, Inc.2014-12-16
Cushing perforating drills are bone cutting and drilling instruments that are used without recall (Z-0542-2015)Instrumed International, Inc.2014-12-16
Cushing burrs are bone cutting and drilling instruments that are used without a power sour recall (Z-0543-2015)Instrumed International, Inc.2014-12-16
Hudson burrs are bone cutting and drilling instruments that are used without a power sourc recall (Z-0544-2015)Instrumed International, Inc.2014-12-16
McKenzie Perforator Drills are bone cutting and drilling instruments that are used without recall (Z-0545-2015)Instrumed International, Inc.2014-12-16
D'errico perforator drills are bone cutting and drilling instruments that are used without recall (Z-0546-2015)Instrumed International, Inc.2014-12-16
McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a recall (Z-0547-2015)Instrumed International, Inc.2014-12-16
Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling instr recall (Z-0548-2015)Instrumed International, Inc.2014-12-16
Galt trephines are bone cutting and drilling instruments that are used without a power sou recall (Z-0549-2015)Instrumed International, Inc.2014-12-16
Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient wit recall (Z-0550-2015)Instrumed International, Inc.2014-12-16
Replacement screw non-springloaded traction tongs are skull tongs for traction used to imm recall (Z-0551-2015)Instrumed International, Inc.2014-12-16
Lock nuts for titanium traction tongs are used in traction skull tongs for traction used t recall (Z-0552-2015)Instrumed International, Inc.2014-12-16
Titanium fixation screws, springloaded are used in traction skull tongs for traction used recall (Z-0553-2015)Instrumed International, Inc.2014-12-16
Traction tong replacement screws, non-springloaded are used in traction skull tongs for tr recall (Z-0554-2015)Instrumed International, Inc.2014-12-16
Gardner-Wells wrenches are used in traction skull tongs for traction used to immobilize a recall (Z-0555-2015)Instrumed International, Inc.2014-12-16
CVB distraction screws are bone cutting and drilling instruments that are used without a p recall (Z-0556-2015)Instrumed International, Inc.2014-12-16
Cloward Spanner gauges are bone cutting and drilling instruments that are used without a p recall (Z-0557-2015)Instrumed International, Inc.2014-12-16
Tonometers are manual devices intended to measure intraocular pressure by applying a known recall (Z-0558-2015)Instrumed International, Inc.2014-12-16
Schoitz weights are manual devices used with Schoitz tonometers and are intended to measur recall (Z-0559-2015)Instrumed International, Inc.2014-12-16
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization recall (Z-2721-2014)Instrumed International, Inc.2014-09-30
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization recall (Z-2722-2014)Instrumed International, Inc.2014-09-30
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization recall (Z-2723-2014)Instrumed International, Inc.2014-09-30
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization recall (Z-2724-2014)Instrumed International, Inc.2014-09-30
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization recall (Z-2725-2014)Instrumed International, Inc.2014-09-30
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization recall (Z-2726-2014)Instrumed International, Inc.2014-09-30
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization recall (Z-2727-2014)Instrumed International, Inc.2014-09-30
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization recall (Z-2728-2014)Instrumed International, Inc.2014-09-30
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization recall (Z-2729-2014)Instrumed International, Inc.2014-09-30
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization recall (Z-2730-2014)Instrumed International, Inc.2014-09-30

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Every clearance here is in the API, with alerts when new ones post.