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

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STAXX(R) XD SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

NA

FDA UDI
Smith & Nephew, Inc.·03596010038814·REPLACEMENT HEAD MED WT STAINLESS ...

Bernafon

FDA UDI
Bernafon AG·05711584004579·CT9 CPX, VC PS MAC CANTEO 9

Axiom® Interpleural Anesthesia

FDA UDI
AXIOM MEDICAL, INCORPORATED·M6651114180·Interpleural Sump, Two Lumens, Round, Silicone,...

MAXCUT CARBIDE BUR (10/pk) FG 700-L

FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811114181·MAXCUT CARBIDE BUR (10/pk) Shape: Cross Cut Tap...

Surgical Instrument

FDA UDI
Jeil Medical Corporation·08800089448708·

Orthoquest

FDA UDI
Young Innovations, Inc.·00840326401187·Cutanium 27° D-Form 016X022

POWDER FREE NITRILE EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

ULTRAGUIDE MR-GUIDE 3000

FDA 510(k)
FDA Class 2 ·Radiology

GMK PRIMARY FIXED TIBIAL INSERT SIZE 3 17MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL, SA·Product code JWH·November 14, 2014

GMK-PRIMARY TIBIAL INSERT FIXED SIZE 3 / 17 MM STD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 5, 2017

ASR ACETABULAR CUPS 50

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·May 14, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 23, 2014

ACCU-CHEK ® MULTICLIX

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·June 2, 2011

Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment

FDA Enforcement
Class II ·Ongoing·Lacrimedics Inc·March 9, 2022

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

Model Number L131, ESSENTIO DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025