21 results · 24ms · Sources: EU EUDAMED, US FDA

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EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Medi-First Plus Flexible Large Patch HW

FDA UDI
Medique Products·00347682106737·A flexible patch of fabric material, coated on...

HOHMANN ELEVATOR RETRACTOR

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896049451·HOHMANN ELEVATOR RETRACTOR

NITANIUM® SUPER ELASTIC ARCHWIRES

FDA UDI
Ortho Organizers, Inc.·00190707059958·.020 X .020 LOWER NITANIUM® SUPER ELASTIC PRO F...

Monoblock Tibial Trial PS Insert

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215042738·

N/A

FDA UDI
Doppkon GmbH & Co. KG·04262494462290·Hook Probe Square Handle Steel D 3.0mm, WL 310mm

23G ETW X 7MM PEN NEEDLE US

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMI·April 29, 2020

ARTHREX FIBERWIRE, MODEL SPU-02NB-3800

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

TRANSVENE CS/SVC LEAD

FDA Adverse Event
Injury ·MPRI·Product code LWS·July 6, 2025

COBALT¿ HF QUAD CRT-D MRI SURESCAN¿

FDA Adverse Event
Malfunction ·MEDTRONIC EUROPE SARL·Product code NIK·February 16, 2026

CAPSUREFIX NOVUS MRI SURESCAN

FDA Adverse Event
Malfunction ·MPRI·Product code DTB·April 8, 2025

COBALT¿ XT HF CRT-D MRI SURESCAN¿

FDA Adverse Event
Injury ·MEDTRONIC EUROPE SARL·Product code NIK·February 24, 2026

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·May 8, 2013

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·September 19, 2014

UNKNOWN DEEP BRAIN STIMULATOR

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·May 12, 2011

CLARIA MRI CRT-D SURESCAN

FDA Adverse Event
Injury ·MEDTRONIC EUROPE SARL·Product code NIK·September 22, 2023

M2A-38 60MM CUP NON FLARED

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 24, 2012

Alinity m System, Part No. 08N53-002

FDA Enforcement
Class II ·Terminated·Abbott Molecular, Inc.·January 12, 2022

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025