16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VasQ
FDA 510(k)
FDA Class 2
·Cardiovascular
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776402341·Bruns Curette 9" hollow hdl str oval #0000
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780187318·Integra® Jarit® Bruns Oval Cup Curette, 9", Str...
Holder, Needle, TC, acc. Berry 18cm
FDA UDI
Geister Medizintechnik GmbH·04057034064184·Holder, Needle, TC, acc. Berry
18cm ...
PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EMERGE MEDICAL PERIARTICULAR AND LOCKING LARGE FRAGMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 28, 2025
Widex
FDA UDI
Widex A/S·05706069914962·WIDEX MOMENT MRB2D (Silver Grey ) 440, Telecoil...
Widex
FDA UDI
Widex A/S·05706069827767·WIDEX EVOKE EBB3D (Silver Grey ) 440, Telecoil,...
BHR ACETABULAR CUP 56MM
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·April 10, 2019
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 24, 2008
OPTISENSE
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011
SENTRA
FDA Adverse Event
Injury
·HISTORICAL CPI ST. PAUL·Product code DTB·July 22, 2013
BIOABSORBABLE INTERFERENCE SCREWS
FDA Adverse Event
Malfunction
·S.B.M. SAS·Product code MAI·August 22, 2024
PKG, METZENBAUM SCISSORS, CURVED LONG, P/N 0250080265. 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
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025