18 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VERTIX 3D-U
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04046114447207·OMOMED SHOULDER SUP SILVER LEFT SIZE 0
Handle
FDA UDI
ADLER ORTHO SPA·08050507130689·HANDLE FOR TURRET
Greenwald Surgical Company, Inc.
FDA UDI
GRACE MANUFACTURING, INC.·10801334000592·Cunningham incontinence clamp, Large
Coverlet®
FDA UDI
BSN MEDICAL, INC.·10035664026612·COVERLET ELASTIC 21/8"X1.5" TAN SMALL DIGIT BULK
CAPELLA
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CONE 1.5
FDA 510(k)
FDA Class 2
·Dental
VAPR3 FOOTSWITCH *EA
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code GEI·December 30, 2019
HEARTMATE 11 SYSTEM CONTROLLER
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·March 24, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·October 23, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 22, 2007
VAPR 3 FOOTSWITCH
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code HRX·August 15, 2023
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025