29 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Edwards Algorithm for Measurement of Blood Hemoglobin
FDA 510(k)
FDA Class 2
·Cardiovascular
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037318096·TRIAL HUMERAL CUP ECCENTRIC SYMMETRIC MOBILITY ...
Zavation
FDA UDI
Zavation LLC·00197157002725·CIF 14x18, 6 deg, -12
GENESIS II TOTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
R501 aortic root cannula without vent line, R502 aortic root cannula with vent line
FDA 510(k)
FDA Class 2
·Cardiovascular
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWP·November 6, 2014
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·August 12, 2011
COULTER AC*T DIFF HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·July 16, 2013
Vasomedical-Biox™ Model 2306 12 CH/ABP COMB Recorder w/Bluetooth
FDA UDI
VASOMEDICAL, INC.·00817980020542·Model 2306 12 CH/ABP COMB Recorder w/Bluetooth
BAB TOUGH STRIPS
FDA Adverse Event
Injury
·KENVUE BRANDS, LLC·Product code KGX·April 25, 2025
BAB TOUGH STRIPS
FDA Adverse Event
Injury
·KENVUE BRANDS, LLC·Product code KGX·April 25, 2025
GS
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code MKJ·November 22, 2023
(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930 (2) RingLoc Hip system Acetabular Bi-Polar Cup: Acetabular Cup, ArCom, 41 MM OD, 28 MM ID: Item No. 11-165206, Lot No. 649750; UDI No. (01) 00880304001923 (17) 230614 (10) 649750 (3) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Cup, ArCom, 52 MM OD, 28 MM ID: Item No. 11-165228; Lot No. 433290; UDI No. (01) 00880304001930 (17) 230612 (10) 433290
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·October 21, 2020
Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
FDA Enforcement
Class I
·Ongoing·Percussionaire Corporation·October 9, 2024
Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
FDA Enforcement
Class I
·Ongoing·Percussionaire Corporation·October 9, 2024
Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
FDA Enforcement
Class I
·Ongoing·Percussionaire Corporation·October 22, 2025
(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930 (2) RingLoc Hip system Acetabular Bi-Polar Cup: Acetabular Cup, ArCom, 41 MM OD, 28 MM ID: Item No. 11-165206, Lot No. 649750; UDI No. (01) 00880304001923 (17) 230614 (10) 649750 (3) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Cup, ArCom, 52 MM OD, 28 MM ID: Item No. 11-165228; Lot No. 433290; UDI No. (01) 00880304001930 (17) 230612 (10) 433290
FDA Recall
Terminated
·Biomet, Inc.·Product code JDI·September 3, 2020
Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2; Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system.
FDA Enforcement
Class II
·Ongoing·Merge Healthcare, Inc.·March 26, 2025
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
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