19 results · 24ms · Sources: EU EUDAMED, US FDA

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OsteoFlo® HydroPutty™

FDA 510(k)
FDA Class 2 ·Orthopedic

Bernafon

FDA UDI
Sbo Hearing A/S·05714464033133·Alpha 5 FW 1.1.0

OsteoMed

FDA UDI
OSTEOMED LLC·00845694022149·FPS Plate Cutter Assembly

Orfit Industries

FDA UDI
Orfit Industries NV·05420028755433·Anti-tilt iBeam® Couch Fixation for SBRT short ...

ELMED

FDA UDI
ELMED INCORPORATED·00842180187382·2 PIECE SHUNT PERITONEAL CATHETER PASSER W/ SMA...

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776206925·HOFFMAN SHUNT PASSER LONG

ELMED INCORPORATED

FDA UDI
ELMED INCORPORATED·00198506061110·2 PIECE SHUNT PERITONEAL CATHETER PASSER W/ SMA...

ELMED INCORPORATED

FDA UDI
ELMED INCORPORATED·00198506075469·2PC SHUNT PERITONEAL CATHETER PASSER W/ SMALL R...

STINGRAY LP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·March 26, 2025

DropSafe Safety Pen Needles

FDA 510(k)
FDA Class 2 ·General Hospital

SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE

FDA 510(k)
FDA Class 2 ·General Hospital

STINGRAY LP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·February 3, 2025

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

STINGRAY? LP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·May 29, 2026

UNK_ULTRACISION HARMONIC FOCUS

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 20, 2019

BATTERY 14.8V, 6.3 AH LI-ION BATTERY

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 14, 2014

FLEXICAP

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·September 1, 2011

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 17, 2013

Revogene, Catalog no. 610210. IVD test instrument

FDA Enforcement
Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022