24 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Vital Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Medical Facets NC
FDA UDI
MEDICAL FACETS NC LLC·M933MDF022301160·1.5mm Headless Compression Screw, 16mm
Diamond Orthopedic, LLC
FDA UDI
DIAMOND ORTHOPEDIC, LLC·B551DMD022301160·1.5mm, Headless Compression Screw, 16mm
SUPERIOR LATERAL VARIAX CLAVICLE PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
ENHANCE-S PLUS H
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·May 1, 2023
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
Widex
FDA UDI
Widex A/S·05706069914818·WIDEX MOMENT MRB2D (Dark cherry ) 330, Telecoil...
SPINNING SPIROS CLOSED MALE LUER, RED CAP
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·June 18, 2021
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN-BENNETT CORP.·Product code CBK·November 5, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 31, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·July 16, 2013
Allura Xper FD20/15; Catalog numbers: 722058
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3) 2082844-002-01058424; 4) 2082844-002-01069017; 5) 2082844-002-01089666; 6) 2082844-002-01090474; 7) 2082844-002-01091269; 8) 2082844-002-01093489; 9) 2082844-002-01113262; 10) 2082844-002-01113711; 11) 2082844-002-01123085; 12) 2082844-002-01123918; 13) 2082844-002-01128966; 14) 2082844-002-01133042; 15) 2082844-002-01146447; 16) 2082844-002-100205; 17) 2082844-002-100749; 18) 2082844-002-100752; 19) 2082844-002-100995; 20) 2082844-002-101425; 21) 2082844-002-523548; 22) 2082844-002-529928; 23) 2082844-002-594800; 24) 2082844-002-643544; 25) 2082844-002-925841; 26) 2082844-002-965540; 27) 2082844-002-982916; 28) 2082844-002-983420; 29) 2082844-002-993905; 30) 2082844-002-995018; 31) 2082844-002-995799; 32) 2082844-002-998943; Radiant infant warmer
FDA Enforcement
Class I
·Completed·DATEX--OHMEDA, INC.·November 6, 2024
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020