19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BriefCase
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113837·VISCO CANNULA 23GA ANGLE 8MM
3DP Lumbar Interbody System
FDA UDI
Genesys Orthopedics Systems LLC·M719GL3DM2035080·Medium 8-Degree 3DP LLIF - 20mm x 35mm
3DP Lumbar Interbody System
FDA UDI
Genesys Orthopedics Systems LLC·M719GL3DS2035080·Small 8-Degree LLIF - 20mm x 35mm
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996133449·LATERAL,0 DEGREE LORDOSIS
SCORPIO NRG X3 PS TIBIAL INSERT #5 12MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·January 29, 2019
SCORPIO U-DOME X3 PATELLA
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code NPJ·January 29, 2019
Scorpio
FDA UDI
Howmedica Osteonics Corp.·07613327014570·Universal Dome Patella
STILLE Uterine Curettes
FDA UDI
Stille AB·07332339205997·UTERINE CURETTE RECAMIER STILLE malleable blunt...
Vu a-POD™
FDA UDI
Seaspine Orthopedics Corporation·10889981037987·35x27mm Trial 8mm 8 deg. The Vu a-POD interver...
UNMIAX LAPAROSCOPIC INSTRUMENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NC-STAT
FDA 510(k)
FDA Class 2
·Neurology
EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 8MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·July 10, 2023
RESTORE ADVANCED RECHARGEABLE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code LGW·October 17, 2008
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013
Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Llc·November 20, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012