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

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TITAN TI SUTURE ANCHOR SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

N/A

FDA UDI
Smith & Nephew, Inc.·00885556007334·BONE CURETTE CURVED 45 DEG 228.6 ...

Bernafon

FDA UDI
Bernafon AG·05711584004456·CT9 CPX, VC PS BE CANTEO 9

MAXCUT CARBIDE BUR (10/pk) FG 332

FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811113971·MAXCUT CARBIDE BUR (10/pk) Shape: Pear; Size: 3...

Surgical Instrument

FDA UDI
Jeil Medical Corporation·08800089448623·

TRUMATCH PERSONALIZED SOLUTIONS

FDA 510(k)
FDA Class 2 ·Orthopedic

PERSYST REVEAL

FDA 510(k)
FDA Class 2 ·Neurology

DONJOY

FDA UDI
DJO, LLC·00888912005845·COLD PAD,SHOULDER,S,LOOP,EH,NS

ALARIS SYSTEM

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·March 7, 2022

SYNCHROMED

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·May 14, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 23, 2014

ASR ACETABULAR CUPS 50

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 13, 2011

EDWARDS INSPIRIS RESILIA AORTIC VALVE

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code LWR·June 26, 2024

SELECTSECURE MRI SURESCAN

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code NVN·June 14, 2019

SELECTSECURE MRI SURESCAN

FDA Adverse Event
Malfunction ·MEDTRONIC, INC.·Product code NVN·June 14, 2019

UNK - PLATES: 3.5 MM LCP HOOK PLATE

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code HRS·October 20, 2021

UNK - SCREWS: LOCKING

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code HWC·October 20, 2021

SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Model Number L231, PROPONENT DR EL MRI Pacemaker

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