24 results · 21ms · Sources: EU EUDAMED, 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