21 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20
FDA 510(k)
FDA Class 2
·Clinical Toxicology
VERTE-STACK® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074520650·SPACER 9192515 CRESCENT PEEK 25X15
Echo® Bi-Metric® Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868273988·
Echo® Press-Fit Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868260902·
ECHO BI-METRIC HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304463363·
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780506188·Integra® Miltex® House Strut Pick, 6-1/4", 0.5m...
NP15
FDA 510(k)
FDA Class 2
·Anesthesiology
PENCAN SPINAL NEEDLE
FDA 510(k)
FDA Class 2
·Anesthesiology
REMEL MACCONKEY AGAR
FDA Adverse Event
Malfunction
·REMEL, INC.·Product code JSI·February 6, 2025
PENCAN®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code BSP·May 6, 2025
I-STAT TROPONIN (HS-TNI ) CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE INC.·Product code MMI·April 14, 2026
M2A-MAGNUM 52-60MM TPR INSR +3
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·December 26, 2018
MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE
FDA Adverse Event
Injury
·ACCESSCLOSURE, INC.·Product code MGB·October 22, 2014
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·June 4, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 5, 2011
66OD X 60 ID MAGNUM ABX PF CUP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·December 3, 2018
M2A-MAGNUM MOD HD SZ 60MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·December 3, 2018
PENCAN®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code BSP·April 10, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025