27 results · 14ms · Sources: EU EUDAMED, US FDA

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LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Large loop, 4mm connector, 1 X REF: EL-200-4 and 10 X REF: EL-200-4, Manufactured by LiNA Medical ApS, Surgery Division.

FDA Recall
Terminated ·LINA Medical ApS Formervangen 5 Glostrup Denmark·Product code KNF·December 1, 2009

LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Small loop, 8mm connector, 1 X REF: EL-160-8 and 10 X REF: EL-160-8, Manufactured by LiNA Medical ApS, Surgery Division.

FDA Recall
Terminated ·LINA Medical ApS Formervangen 5 Glostrup Denmark·Product code KNF·December 1, 2009

LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Large loop, 8mm connector, 1 X REF: EL-200-8 and 10 X REF: EL-200-8, Manufactured by LiNA Medical ApS, Surgery Division.

FDA Recall
Terminated ·LINA Medical ApS Formervangen 5 Glostrup Denmark·Product code KNF·December 1, 2009

Pathfast D-Dimer, Reference number: PF1051-KUS

FDA Recall
Terminated ·Lsi Medience Corporation 13-4 Uchikanda·Product code GHH·August 16, 2016

SPS Blue Line Tube Clamp Adapters, Product No. BL120M

FDA Recall
Terminated ·Southern Prosthetic Supply Co.·Product code ISH·October 3, 2006

VSP Shock Module (as part of a prosthetic foot).

FDA Recall
Terminated ·Ossur North America Inc·Product code ISH·June 15, 2004

VS-1000 Senator Prosthetic Foot, (Categories 5 and 6, sizes 22-30 cm, both Left and Right) Applied Composite Technology, Gunnison, UT.

FDA Recall
Terminated ·Applied Composite Technology·Product code ISH·June 20, 2007

OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.

FDA Recall
Terminated ·Ossur Americas·Product code ISH·May 30, 2022

JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE;

FDA Recall
Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code FSH·February 23, 2017

JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE;

FDA Recall
Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code FSH·February 23, 2017

Modular Knee Joint with Friction Brake

FDA Recall
Terminated ·Bock, Otto, Orthopedic Ind, Inc·Product code ISH·July 15, 2004

Re-Flex VSP and Low Profile Re-Flex VSP external prosthetic foot modules with integrated shock absorber, Model numbers RFXS0002, RFXS0003, RFLS0006 and RFL50007

FDA Recall
Terminated ·Ossur Grjothals 5 Reykjavik Ireland·Product code ISH·November 3, 2006

iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot.

FDA Recall
Terminated ·Otto Bock Healthcare GmbH Max-Nader-Str. # 15 Duderstadt Germany·Product code ISH·October 23, 2015

Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy with a pyramid receiver and is intended where there is a need to offset the tube horizontally in relation to other components. It is fully compatible with all standard 30mm prosthetic pylons. (3) Offset: 14,5mm (0.57inch).

FDA Recall
Terminated ·Ossur North America Inc·Product code ISH·October 24, 2013

Thoracentesis/ Paracentesis Kit 10/CS; STERILE;

FDA Recall
Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code FSH·February 23, 2017

ILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA]; STERILE;

FDA Recall
Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code FSH·February 23, 2017

Celsus prosthetic foot, Product Number 103658-00. The Celsus is intended for low impact level lower limb prosthesis users weighing up to 300 lbs.

FDA Recall
Terminated ·College Park Industries, Inc.·Product code ISH·April 5, 2012

JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE;

FDA Recall
Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code FSH·February 23, 2017

The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is composed of the RHEO KNEE and the PROPRIO FOOT, both already existing products from ssur. Both are a battery powered micro-processor controlled prosthetic device and are connected through a shared battery. The knee and the foot have different sensor systems that provide real-time information used to control knee joint resistance and the flexion/extension of the ankle during the gait cycle. Default control parameters are provided with the device but can be manually adjusted by a certified prosthetist through software (knee), or by a certified prosthetist or the user through controls on the device itself (foot). SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25 30 and less than 100kg for foot Categories 22, 23 and 24. The system is not intended for athletic use.

FDA Recall
Terminated ·Ossur Americas, Inc.·Product code ISH·February 12, 2012

LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module with adjustable shock absorber and rotation with progressive stiffening -Build height: with male pyramid adapter 145 - 153mm (5 11/16 - 6 ) with female pyramid adapter 153 165mm (6 - 6 1/2) -Male pyramid adapter -Female pyramid adapter -Maintenance free, no lubrication required -Maximum weight: 147kg (325lbs) -Available in sizes 22-30

FDA Recall
Terminated ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISH·March 4, 2015