18 results
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24ms
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Sources: EU EUDAMED, US FDA
Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATELLA 34MM RGX 3 PEG SER A PATELLA 37MM Product Usage: The Regenerex Series A Patella can be used for any non-cemented resurfaced 3-peg patella application within the Vanguard Complete Knee System. 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code MBH·March 22, 2017
Smith & Nephew Endoscopic Disposable Blades: FULL RADIUS BLADE, 5.5MM,SER 3000 Part #: 7206010. DYONICS Series 3000 BONECUTTER Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities. Specific applications may include knee and shoulder reconstructive procedures such as notchplasty and acromioplasty.
FDA Recall
Terminated
·Smith & Nephew, Inc. Endoscopy Division·Product code NBH·May 7, 2009
Precision Ice One-Patient-Use Control Unit and Wrap System (Model # 4BB02BK). The device is intended to reduce edema and promote healing of soft-tissue injuries and lymphedema through stimulation of the lymphatic system. The device is a therapeutic system which consists of a control unit and fluid circulating pads. The pads are mounted in wraps designed for specific parts of the body such as ankle, knee, elbow, and shoulder. The pads provide cold treatment and pressure which help promote healing. The owner's manual is labeled in part: "PRO TRAINERS' CHOICE COMPANY, INC.***www.precisionice.com***[email protected]***Mailing Address PO Box 27***Kingston, WA 98346 USA***Phone: 360-297-3902***Shipping Address***26129 Calvary Lane NE, Suite 200***Kingston, WA 98346 USA***Fax: 360-297-3903". The sticker which is placed on the back of the control board is labeled in part: "MOD#4BB02BK***SER#100***". The shipping box is labeled in part: "Pro Trainers' Choice' LLC***Model #4BB02BK***Serial #100____***". The knee wrap is labeled in part: "***Pro Trainers' Choice Co. Inc./Precision Ice One Patient Use Knee Wrap***#1BK01051KN***This device is to be used for one patient only; do not re-use!***".
FDA Recall
Terminated
·Pro Trainers' Choice Company·Product code ILO·April 18, 2011
Euflexxa (1% sodium hyaluronate). Pre-filled syringe, Rx only, 3 syringes per carton; Manufactured by Ferring Pharmaceuticals In, Parsippany, NJ 07054; Manufactured by Bio-Technology General (Israel Ltd. Be er Tuvia, Kiryat Malachi 83104 Israel. Indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.
FDA Recall
Terminated
·Ferring Pharmaceuticals Inc·Product code MOZ·April 16, 2010
Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human serum or plasma. Antibodies to apolipoprotein A1 combine with apolipoprotein A1 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 804 nm, is directly proportional to the concentration of apolipoprotein A1 in the sample.
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code DER·May 16, 2018
GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.
FDA Recall
Terminated
·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code FER·December 12, 2018
Clinical Chemistry Apolipoprotein A1, List Number 9D92-20
FDA Recall
Terminated
·Abbott Laboratories Diagnostic Div·Product code DER·November 10, 2005
STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-valve/auxiliary water connector) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.1
FDA Recall
Terminated
·GA HEALTH COMPANY LIMITED
Unit 18, 21/F
Metropole Square; 2 On Yiu Street ,Shatin, N.T
Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020
Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004
FDA Recall
Terminated
·GA HEALTH COMPANY LIMITED
Unit 18, 21/F
Metropole Square; 2 On Yiu Street ,Shatin, N.T
Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020
Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846
FDA Recall
Terminated
·GA HEALTH COMPANY LIMITED
Unit 18, 21/F
Metropole Square; 2 On Yiu Street ,Shatin, N.T
Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020
Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet Connector Diversatek Healthcare 102 E.Keefe Ave. Milwaukee,WI 53212 USA Product Code: 1203-72
FDA Recall
Terminated
·GA HEALTH COMPANY LIMITED
Unit 18, 21/F
Metropole Square; 2 On Yiu Street ,Shatin, N.T
Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020
ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector Product Code: 345SVVO4
FDA Recall
Terminated
·GA HEALTH COMPANY LIMITED
Unit 18, 21/F
Metropole Square; 2 On Yiu Street ,Shatin, N.T
Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020
Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046
FDA Recall
Terminated
·GA HEALTH COMPANY LIMITED
Unit 18, 21/F
Metropole Square; 2 On Yiu Street ,Shatin, N.T
Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020
ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1
FDA Recall
Terminated
·GA HEALTH COMPANY LIMITED
Unit 18, 21/F
Metropole Square; 2 On Yiu Street ,Shatin, N.T
Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020
STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229
FDA Recall
Terminated
·GA HEALTH COMPANY LIMITED
Unit 18, 21/F
Metropole Square; 2 On Yiu Street ,Shatin, N.T
Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020
Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy Valve Manufactured for: Diversatek Healthcare 102 E.Keefe Ave. Milwaukee, WI 53212 USA Product Code: 1203-71
FDA Recall
Terminated
·GA HEALTH COMPANY LIMITED
Unit 18, 21/F
Metropole Square; 2 On Yiu Street ,Shatin, N.T
Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020
STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10232
FDA Recall
Terminated
·GA HEALTH COMPANY LIMITED
Unit 18, 21/F
Metropole Square; 2 On Yiu Street ,Shatin, N.T
Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020
STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.2
FDA Recall
Terminated
·GA HEALTH COMPANY LIMITED
Unit 18, 21/F
Metropole Square; 2 On Yiu Street ,Shatin, N.T
Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020