16 results · 26ms · Sources: EU EUDAMED, US FDA

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THD REVOLUTION

FDA 510(k)
FDA Class 2 ·Radiology

RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40

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

THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

AESCULAP SURGICAL INSTRUMENTS

FDA Adverse Event
Injury ·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·November 27, 2019

AESCULAP SURGICAL INSTRUMENTS

FDA Adverse Event
Injury ·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·November 27, 2019

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 14, 2024

Matrixx System

FDA UDI
NEXXT SPINE, LLC·00889929065655·Corpectomy, 14Dx16Wx57H 6°

Matrixx System

FDA UDI
NEXXT SPINE, LLC·00889929065372·Corpectomy, 14Dx16Wx57H 0°

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 20, 2022

530G INSULIN PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 4, 2014

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 27, 2011

BD SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·July 10, 2019

BD SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·July 10, 2019

BD PRECISIONGLIDE SYRINGE ALLERGY 1ML W/ NEEDLE 28X1/2 RB

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·May 31, 2019

PKG, 5MM SHAFT, NEEDLE HOLDER, STRAIGHT, 45CM, P/N 0250080588 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

FDA Enforcement
Class II ·Terminated·Stryker Endoscopy·December 24, 2014