21 results · 22ms · Sources: EU EUDAMED, 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