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

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ANYRIDGE INTERNAL IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

Corin BiPolar-i

FDA UDI
CORIN LTD·05056139234460·Corin BiPolar-i Ø55/28mm

Copper Ni-Ti - Archwire

FDA UDI
ORMCO CORPORATION·00889989028843·COPPER NITI 40 BAF19X25LO LG PK10

Leva® Anterior Interbody System

FDA UDI
Spine Wave, Inc.·10840642108170·Screw, 5 mm x 35 mm

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K1100550·Caddie, Misc Screws

ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058

FDA 510(k)
FDA Class 2 ·Cardiovascular

BMT ANSCORE HEALTH MANAGEMENT SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 12, 2026

ENDURO MENISCAL COMPONENT F2 22MM

FDA Adverse Event
Malfunction ·AESCULAP AG & CO. KG·Product code KRO·December 9, 2014

ENDURO MENISCAL COMPONENT F2 10MM

FDA Adverse Event
Malfunction ·AESCULAP AG AND CO. KG·Product code KRO·January 14, 2015

CHARGING SYSTEM

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 8, 2013

CBK

FDA Adverse Event
Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·March 16, 2011

NATURALYTE

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 8, 2014

UNKNOWN MICROCATHETER

FDA Adverse Event
Injury ·COVIDIEN (IRVINE)·Product code DQY·May 30, 2017

ENDURO MENISCAL COMPONENT F1 10MM

FDA Adverse Event
Injury ·AESCULAP IMPLANT SYSTEMS·Product code KRO·October 11, 2016

BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

FDA Adverse Event
Malfunction ·CAREFUSION 303, INC.·Product code BRY·January 8, 2026

EMBLEM S-ICD Model A209

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021