18 results · 21ms · Sources: EU EUDAMED, US FDA

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Stone Retrieval Balloon

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

NuVasive

FDA UDI
Nuvasive, Inc.·00887517949110·Adjustable Pistol Grip XL Inserter

Integra® Jarit®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780454656·Integra® Jarit® Hibbs Retractor, 9-1/4", 19mm W...

DEBAKEY FORCEPS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896100589·DEBAKEY FORCEPS ROUND HANDLE COUNTER WEIGHT

Initia Total Hip System

FDA UDI
KYOCERA CORPORATION·04547898306877·MX LINER 36-66/70

DESS dental smart solutions

FDA UDI
TERRATS MEDICAL SL.·08435457200369·External Hex Universal

Initia Total Hip System

FDA UDI
KYOCERA MEDICAL CORPORATION·04580810058423·"MX LINER 36-66/70 Size:36-66/68/70 Type:Elevat...

ACUMED

FDA UDI
Acumed LLC·10806378013522·2.7mm x 65.0mm Cortical Screw

ACUMED

FDA UDI
Acumed LLC·10806378013539·2.7mm x 65.0mm Cortical Screw

CEMENT IT! UNIVERSAL C&B

FDA 510(k)
FDA Class 2 ·Dental

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TETRACYCLINE (0.12-128 UG/ML)

FDA 510(k)
FDA Class 2 ·Microbiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 28, 2025

ENPULSE

FDA Adverse Event
Death ·MEDTRONIC MED REL, INC.·Product code DXY·August 10, 2011

SMALL BATTERY DRIVE

FDA Adverse Event
Malfunction ·SYNTHES OBERDORF·Product code HWE·October 24, 2014

UNK

FDA Adverse Event
Injury ·ETHICON INC.·Product code FTL·July 1, 2013

ANIMAS INSULIN CARTRIDGE

FDA Adverse Event
Injury ·ANIMAS CORPORATION·Product code LZG·October 8, 2015

ANSPACH***REF SP-5000-00***Threaders, Arthroscopic Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems

FDA Enforcement
Class II ·Terminated·The Anspach Effort, Inc.·July 2, 2014

Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

FDA Enforcement
Class II ·Terminated·Bayer Corp·June 11, 2014