16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Surgical face mask (Model: Flat Ear Loop/CN102)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NorthStar
FDA UDI
Seaspine Orthopedics Corporation·10889981197469·Smooth Shank Poly. Screw, 3.5mm x 34mm
SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·January 11, 2021
GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
PENTRA 5D
FDA 510(k)
FDA Class 2
·Hematology
SYRINGE 0.3ML 31GA 8MM HALFUNIT 10BG 500
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·December 8, 2020
Gibralt®
FDA UDI
INNO Holdings, Inc.·M711050002035340·Posterior Cervical Screw Assembly, 3.5mm X 34mm...
Gibralt
FDA UDI
Choice Spine, LP·10885862247551·
BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·January 11, 2023
BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·July 6, 2022
HEM-O-LOK POLYMER CLIPS
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FZP·October 17, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 3, 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
VASSALLO GT
FDA Adverse Event
Injury
·FILMECC CO., LTD.·Product code DQX·October 3, 2024
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