22 results · 34ms · Sources: EU EUDAMED, US FDA

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Range/Denali/Mesa Spinal System

FDA 510(k)
FDA Class 2 ·Orthopedic

CoRoent

FDA UDI
Nuvasive, Inc.·00887517637857·CoRoent Ant TLIF PEEK, 15x10x32mm 15°

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04064984699571·GENUMEDI PSS BLUE, SIZE V

DD base P HI

FDA UDI
Dental Direkt GmbH·EDDIK503251·DD medical polymers (PMMA), made from PMMA, are...

AngioSystems Tray

FDA UDI
ANGIOSYSTEMS, INCORPORATED·00816611026397·

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306820021·Marina Dissector, Concave Shovel Tip, Curved Sh...

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100110·FEASTER SPECULUM SOLID WIDE

DeRoyal

FDA UDI
DEROYAL INDUSTRIES, INC.·00749756250184·THERA-BAND® EXERCISE BAND

PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES

FDA 510(k)
FDA Class 2 ·Orthopedic

DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE

FDA 510(k)
FDA Class 2 ·Neurology

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·March 27, 2023

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197399401·Tebbet Breast Retractor 150x25...

Capsule Polishers

FDA UDI
AURORA SURGICAL, LLC·08175700153065·Kraff Capsule Polisher, 25g, Irrigation Port in...

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 15, 2021

T:SLIM G5 SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OYC·June 21, 2019

IHEARTEST

FDA Adverse Event
Malfunction ·IHEAR MEDICAL, INC.·Product code EWO·August 17, 2022

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·October 7, 2014

CASHMERE 14 - PLATINUM MICROCOIL

FDA Adverse Event
Malfunction ·MICRUS ENDOVASCULAR, LLC·Product code HCG·June 6, 2013

HEARTSTART MRX

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·June 7, 2011

Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090

FDA Enforcement
Class II ·Ongoing·Medtronic Inc·January 21, 2026