74 results
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15ms
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Sources: EU EUDAMED, US FDA
MyRay RXDC dental unit x-ray unit
FDA Enforcement
Class II
·Terminated·CEFLA DENTAL GROUP·May 29, 2013
Spectrum Medical Quantum Standard heat exchanger
FDA Enforcement
Class II
·Terminated·QURA S.R.L.·August 18, 2021
ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)18033509855979
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS, RX ONLY, UDI: (01) 18033509855955
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS, RX ONLY, UDI: (01) 18033509855962
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
PhenoMATRIX
FDA Enforcement
Class II
·Ongoing·Copan WASP·May 28, 2025
ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX ONLY, UDI: (01) 18033509855948
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction; Photocoagulation of dermatological vascular lesions; Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions; Inflammatory acne
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·January 23, 2013
MyLab Seven, Model 6400
FDA Enforcement
Class II
·Terminated·ESAOTE S.P.A.·October 31, 2018
MyLab Gamma, Model 7410
FDA Enforcement
Class II
·Terminated·ESAOTE S.P.A.·October 31, 2018
MyLab Alpha, Model 7400
FDA Enforcement
Class II
·Terminated·ESAOTE S.P.A.·October 31, 2018
Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented lesions; Hair and tattoo removal; The incision, excision, ablation, vaporization of soft tissue for general dermatology. Ruby 694nm: Cutting, vaporization and ablation of soft tissue; Tattoo removal; Treatment of benign pigmented lesions.
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·January 23, 2013
Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG 1064 nm: Coagulation and hemostasis of benign vascular lesions (e.g. port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins, scars, straie and psoriasis; Treatment of benign pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments; Treatment of facial wrinkles (e.g. periocular and periorbital); Removal of unwanted hair, for the stable longterm, or permanent, hair reduction, including Fitzpatrick IVI and suntanned skin types; For the treatment of pseudofolliculitis barbae (PFB); Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; For use on all skin types (Fitzpatrick IVI) including tanned skin. Alexandrite 755 nm: Coagulation and hemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types 1VI, including suntanned skin types; Pigmented lesions; Wrinkles. Nd: YAG 1320 nm: General surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue; Treatment of periorbital and periocular wrinkles, fine lines and wrinkles, treatment of back acne and atrophic acne scars. IPL: Permanent hair reduction; Photocoagulation of dermatological vascular lesion (i.e. face telangiectasia); Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions.
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·January 23, 2013
10 GAUGE DRILL, CODE INTVM-DRL
FDA Enforcement
Class II
·Terminated·BIOPSYBELL S.R.L.·May 26, 2021
11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK
FDA Enforcement
Class II
·Terminated·BIOPSYBELL S.R.L.·May 26, 2021
CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051
FDA Enforcement
Class II
·Terminated·BIOPSYBELL S.R.L.·May 26, 2021
8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB
FDA Enforcement
Class II
·Terminated·BIOPSYBELL S.R.L.·May 26, 2021
8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB
FDA Enforcement
Class II
·Terminated·BIOPSYBELL S.R.L.·May 26, 2021
CEMIX - CEMENT MIXING SYSTEM, CODE INTV-MMS
FDA Enforcement
Class II
·Terminated·BIOPSYBELL S.R.L.·May 26, 2021
10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC
FDA Enforcement
Class II
·Terminated·BIOPSYBELL S.R.L.·May 26, 2021