1,090 results
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16ms
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Sources: EU EUDAMED, US FDA
O-Ring Abutment 4.1mm(D) x 2mm(H) Item: OSO20 Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code DZE·November 25, 2015
O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code DZE·November 25, 2015
O-Ring Abutment 4.1mm(D) x 6mm(H) Item: OSO60 Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code DZE·November 25, 2015
Rigid Curved Positioner, product code RCP; Rigid Curved Positioner O-Ring, product code RCPOR.
FDA Recall
Terminated
·Surgical Devices/Covidien·Product code GDW·September 23, 2009
Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be used for circumcision surgeries
FDA Recall
Terminated
·Aesculap Implant Systems LLC·Product code HFX·October 28, 2016
Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100
FDA Recall
Terminated
·Atrium Medical Corporation·Product code PAD·May 7, 2015
Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
FDA Recall
Terminated
·Atrium Medical Corporation·Product code PAD·May 7, 2015
EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
FDA Recall
Terminated
·Atrium Medical Corporation·Product code PAD·May 7, 2015
Ocean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100
FDA Recall
Terminated
·Atrium Medical Corporation·Product code PAD·May 7, 2015
CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code LXH·September 21, 2018
CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code LXH·September 21, 2018
CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code LXH·September 21, 2018
DeVilbiss Model DV5x Series CPAP with Heated Humidifier Device is intended to treat Obstructive Sleep Apnea (OSA) in patients weighing 30 Kg and above. The device creates a positive pressure in the patient's airway to prevent collapse of the airway while the patient is sleeping. The heated humidifier provides additional humidity to the air supplied to the patient. The heated humidifier has a removable water chamber for filling with water and ease of cleaning.
FDA Recall
Terminated
·Sunrise Medical HHG Inc. dba DeVilbiss Healthcare·Product code BZD·March 11, 2011
Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Cardinal Health NPWT PRO family of systems provides care in the acute, extended and home care settings.
FDA Recall
Terminated
·Cardinal Health 200, LLC·Product code OMP·June 4, 2020
Cardinal Health NPWT Occlusion Detection Canister 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Cardinal Health NPWT PRO family of systems provides care in the acute, extended and home care settings.
FDA Recall
Terminated
·Cardinal Health 200, LLC·Product code OMP·June 4, 2020
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousfistulae and synthetic dialysis grafts
FDA Recall
Terminated
·Arrow International Inc·Product code DXE·September 20, 2021
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousfistulae and synthetic dialysis grafts
FDA Recall
Terminated
·Arrow International Inc·Product code DXE·September 20, 2021
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousfistulae and synthetic dialysis grafts
FDA Recall
Terminated
·Arrow International Inc·Product code DXE·September 20, 2021
Amvex Integrated Flowmeter; a nonback-pressure compensated Bourdon gauge flowmeter; Amvex Corporation, 25B East Pearce St, Richmond Hill, Ontario L4B 2M9, Canada; Model No. FI. The Integrated Flowmeter has two parts, the Outlet port and the Flowmeter port. The Outlet port is intended to be used as a standard wall Outlet, delivering a high flow of gas to secondary equipment. The Flowmeter port is intended to deliver a fixed flow of gas to patient or equipment.
FDA Recall
Terminated
·Amvex Corporation·Product code CCN·May 29, 2009
Wound Dressing Kit - Tier I, 10 MM Flat Drain; product code 0877061. Medela Healthcare, McHenry, IL 60051; A Wound Drain Kit containing a 10 mm Flat Drain, antimicrobial gauze pad, non-adherent wound contact layer, transparent dressing, tubing clamp, barrier film wipe, adhesive tape, sterile saline, and suction extension tubing; 15 individually bagged kits per case; Some of the kits were mislabeled as Invia Wound Therapy Tier III Wound Dressing Kit, 15 Fr Round Channel Drain, product 0877067, lot 370118
FDA Recall
Terminated
·Medela Inc·Product code MCY·July 27, 2011