502 results
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15ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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VITROS 5600 Integrated System (New and Refurbished)
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·March 13, 2024
VITROS 3600 Immunodiagnostic System (New and Refurbished)
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·March 13, 2024
Class IV New Era medical laser device
FDA Enforcement
Class II
·Ongoing·Inova Lasers LLC·November 25, 2020
SMV DSX New Line, System, Tomography, Computed, Emission
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 21, 2026
NEW SKIN LIQUID BANDAGE CLEAR .3FL OZ, SKU 999417
FDA Enforcement
Class II
·Ongoing·Family Dollar Stores, Llc.·August 24, 2022
Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800535001, Sterile, LD0620A - C Section - New Braunfels
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
FDA Enforcement
Class II
·Ongoing·New Medical Technologies Gmbh·February 12, 2025
Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;
FDA Enforcement
Class II
·Ongoing·New Medical Technologies Gmbh·February 12, 2025
Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080
FDA Enforcement
Class II
·Ongoing·New Standard Device Inc·September 7, 2022
1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
FDA Enforcement
Class II
·Completed·New Standard Device Inc·June 15, 2022
Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A
FDA Enforcement
Class II
·Ongoing·New Standard Device Inc·June 29, 2022
StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, and General Surgery.
FDA Enforcement
Class II
·Terminated·New Star Lasers, Inc.·July 8, 2015
ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; for use in the treatment of fine lines and wrinkles; for treatment of back acne and atrophic acne scars; for treatment of reflux of the great and small saphenous veins associated with varicose veins and varicosities, and; for laser assisted lipolysis
FDA Enforcement
Class II
·Terminated·New Star Lasers, Inc.·October 12, 2016
CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermatology for incision, excision, ablation, and vaporization with hemostasis of soft tissue; For treatment of fine lines and wrinkles; For mild to moderate inflammatory acne vulgaris; For back acne and atrophic scarring, and; For podiatry, (incision, excision, and coagulation of soft tissue), including. matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas
FDA Enforcement
Class II
·Terminated·New Star Lasers, Inc.·October 12, 2016
VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas. The temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)
FDA Enforcement
Class II
·Terminated·New Star Lasers, Inc.·October 12, 2016
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
FDA Enforcement
Class II
·Terminated·New Era Orthopaedics, LLc·August 15, 2018
'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
FDA Enforcement
Class II
·Ongoing·New Standard Device Inc·June 21, 2023
PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700
FDA Enforcement
Class II
·Terminated·Polymer Technology Systems, Inc.·January 29, 2020