14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Male Latex Condom
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NorthStar
FDA UDI
Seaspine Orthopedics Corporation·10889981197476·Smooth Shank Poly. Screw, 3.5mm x 36mm
NUAMPS
FDA 510(k)
FDA Class 2
·Neurology
HARDYDISK NAFCILLIN, 1 MCG
FDA 510(k)
FDA Class 2
·Microbiology
Gibralt
FDA UDI
Choice Spine, LP·10885862247568·
Gibralt®
FDA UDI
INNO Holdings, Inc.·M711050002035360·Posterior Cervical Screw Assembly, 3.5mm X 36mm...
DUODERM
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code NAD·September 10, 2024
CAPIO SUTURE
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code MFJ·October 17, 2008
ADAPTA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NVZ·August 11, 2011
DEPUY ASR XL FEM IMP SIZE 47
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KXA·July 3, 2013
VASSALLO GT
FDA Adverse Event
Injury
·FILMECC CO., LTD.·Product code DQX·October 3, 2024
Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black. Intended to detect trends and track glucose patterns in persons with diabetes. The G4 PLATINUM CGM System and G4 PLATINUM (Professional) CGM System use the same receiver, MT20649. The kits differ due to other kit contents, such as indications for use and professional receiver shield.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
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