31 results · 22ms · Sources: EU EUDAMED, US FDA

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DISPOSABLE ENDOSCOPIC CANNULA

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526550124·GENUMEDI PT KNEE SUP SILVER L EW III

Accent Buccal Tube

FDA UDI
ORMCO CORPORATION·00889989053814·ORTHOS ACCENT LSM 5SGL WDX -10TX22 L

OsteoMed

FDA UDI
OSTEOMED LLC·00845694003995·Fracture Plate, 6 Hole DCP, 47mm

MHLX7EC TRANSDUCER

FDA 510(k)
FDA Class 2 ·Radiology

LUMANOSITY CELEBRITY, MODEL 204

FDA 510(k)
FDA Class 2 ·Physical Medicine

HISTOACRYL FLEXIBLE PACK 5

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·December 3, 2019

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·February 22, 2023

CANNULA

FDA Adverse Event
Malfunction ·MENTOR WORLDWIDE LLC·Product code CAN·August 25, 2017

ROD, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019

5.5 TI CANNULATED TRANSLATION SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019

FINELINE II

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code DTB·October 3, 2014

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·May 31, 2013

COLLEAGUE PRE-P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 25, 2011

POLARIS SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·January 8, 2020

CATHETER MOUNT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZO·August 6, 2014

PEDICLE SCREW UNSPECIFIED

FDA Adverse Event
Malfunction ·ZIMMER BIOMET SPINE INC.·Product code NKB·April 20, 2021

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

PEDICLE SCREW UNSPECIFIED

FDA Adverse Event
Malfunction ·ZIMMER BIOMET SPINE INC.·Product code NKB·April 20, 2021

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