16 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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