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