288 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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One Way Valve/Male to Female Flow, 22 mm I.D./22 mm O.D., Ref 396799, Lot ***, SINGLE USE ONLY, Latex Free, Quantity 50 Each Manufactured for and Distributed by RUSCH 2450 Meadowbrook Parkway, Duluth, GA 30098, Made in Taiwan.
FDA Recall
Terminated
·Rusch Inc·Product code CBP·February 3, 2004
NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
FDA Enforcement
Class II
·Terminated·Medtronic Xomed, Inc.·January 4, 2017
Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S.
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code JOH·November 17, 2006
Zimmer Trilogy Acetabular System Shell with Cluster Holes, Porous, 60mm O.D., Tivanium TI-6AL-4V Alloy, Hip Prosthesis Component, REF 6200-060-22, Catalog # 00-6200-060-22, Zimmer, Inc., Warsaw, IN, 46580.
FDA Recall
Terminated
·Zimmer Inc.·Product code LPH·October 19, 2007
SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delivery system intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures. Intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures.
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code PDR·May 13, 2015
Bivona Adult Tracheostomy Tube, Labeled I.D. 6.0 mm, O.D. 8.7 mm, A 7.0 mm, B 0 mm, C 53.0 mm, Mfrd by Smiths Medical Critical Care; REF 60A160.
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code JOH·August 11, 2006
Zimmer Periarticular Locking Plate System Cannulated Drill Standard Quick-Connect 2.7 mm O.D., Item Number/EDI 00236017127, Nonsterile. orthopedic surgical instrument.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·October 4, 2017
Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code LXH·November 9, 2017
Bivona Adult Tracheostomy Tube, I.D. 8.5 mm, O.D 11.0 mm, Length 88 mm, TTS 11.8 mm, Mfrd by Smiths Medical Critical Care; Product code 670185.
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code JOH·August 31, 2006
Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3652, Size 52mm O.D., use with 36 mm Head
FDA Recall
Terminated
·Wright Medical Technology Inc·Product code KWY·January 3, 2007
Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3655, Size 55mm O.D., use with 36 mm Head
FDA Recall
Terminated
·Wright Medical Technology Inc·Product code KWY·January 3, 2007
Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3651, Size 51mm O.D., use with 36 mm Head
FDA Recall
Terminated
·Wright Medical Technology Inc·Product code KWY·January 3, 2007
Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-2241, Size 41mm O.D., use with 22 mm Head
FDA Recall
Terminated
·Wright Medical Technology Inc·Product code KWY·January 3, 2007
Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3654, Size 54mm O.D., use with 36 mm Head
FDA Recall
Terminated
·Wright Medical Technology Inc·Product code KWY·January 3, 2007
Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3650, Size 50mm O.D., use with 36 mm Head
FDA Recall
Terminated
·Wright Medical Technology Inc·Product code KWY·January 3, 2007
Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3653, Size 53mm O.D., use with 36 mm Head
FDA Recall
Terminated
·Wright Medical Technology Inc·Product code KWY·January 3, 2007
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 59 mm Number: 00-8065-556-28
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·November 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 61 mm Number: 00-8065-558-32
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·November 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 57 mm Number: 00-8065-554-32
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·November 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22mm, Neutral, O.D. Cup with Spacers, 51 mm Item Number: 00-8065-548-22
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·November 11, 2020