101 results
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7ms
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Sources: EU EUDAMED, US FDA
LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.
FDA Enforcement
Class II
·Terminated·Tearscience, Inc·October 26, 2016
Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C; b) CAN KIT, REF DYKM1184; c) DENTAL CDS, REF CDS984010B; d) EGD KIT, REF DYK1253578F; e) EGD REG KIT, REF DYKE1830; f) ENDO KIT, REF DYKE1516A; g) ERCP REG KIT, REF DYKM2127; h) GI PACK, REF DYKE1898; i) KIT, PEG, REG, REF DYKM2128; j) KIT,1500CC, 50CS, REF DYKM2126; k) LITHOTOMY, REF DYNJ909937; l) MAJOR BASIC, REF DYNJ909703; m) MINOR GENERAL SURGERY, REF DYNJ909940; n) SUCTION SET UP KIT, REF DYKM1187A; o) TURNOVER KIT, REF DYKC1274A; p) TURNOVER KIT MKT STRAPS, REF DYKC1309A; q) U BAR, REF DYNJ902374K
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 28, 2024
Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
FDA Enforcement
Class II
·Completed·Exactech, Inc.·August 18, 2021
Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.
FDA Enforcement
Class II
·Completed·Exactech, Inc.·August 18, 2021
Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·April 4, 2018
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
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
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
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 57 mm Number: 00-8065-554-26
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·November 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 59 mm Number: 00-8065-556-26
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·November 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 61 mm Number: 00-8065-558-22
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·November 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 61 mm Number: 00-8065-558-26
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·November 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 57 mm Number: 00-8065-554-28
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·November 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32mm, Neutral, O.D. Cup with Spacers, 49 mm Item Number: 00-8065-546-32
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·November 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 51mm Number: 00-8065-948-32
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·November 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 59 mm Number: 00-8065-556-22
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, 59 mm Number: 00-8065-556-32
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·November 11, 2020