22 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES
FDA 510(k)
FDA Class 2
·Ophthalmic
NA
FDA UDI
MAKO SURGICAL CORP.·00848486002756·Fixed Driver Handle
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK111151·DD tempMED are pre-colored dental milling blank...
Axiom® Sump-n-Sheath®
FDA UDI
AXIOM MEDICAL, INCORPORATED·M6651111570·Sump-n-Sheath®, Sump Drain, Three Lumens, Silic...
Globe Scientific
FDA UDI
GLOBE SCIENTIFIC INC.·00840095601139·Cuvette, Spectrophotometer, Square, 4.5mL (10mm...
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08806390850018·
Summa Orthopaedics System Surgical Instrument
FDA UDI
Jeil Medical Corporation·08806390867320·
HIP GENERAL OFFSET-30 BROACH HANDLE - LEFT
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LXH·April 7, 2021
E-BASIC SINGLE BREAST PUMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·May 24, 2022
MBT CEM KEEL TIB TRAY SZ2.5
FDA Adverse Event
Injury
·9616671 DEPUY (IRELAND)·Product code NJL·May 14, 2013
TAXUS® LIBERTÉ®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·September 23, 2014
POSTERIOR CHAMBER LENS
FDA Adverse Event
Other
·ALCON RESEARCH, LTD/ HUNTINGTON·Product code HQL·May 26, 2011
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·August 17, 2022
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·December 28, 2011
CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013
Artis Q.zen ceiling, Model Number 10848354
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024