17 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SIRONA DENTAL CAD/CAM SYSTEM
FDA 510(k)
FDA Class 2
·Dental
BCL2 BA P20
FDA UDI
AGILENT TECHNOLOGIES, INC.·05700574026585·BCL2 BA P20
NA
FDA UDI
Smith & Nephew, Inc.·03596010038821·COMBINATION MALLET 10 OZ
MAXCUT CARBIDE BUR (10/pk) FG 701-L
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811114211·MAXCUT CARBIDE BUR (10/pk) Shape: Cross Cut Tap...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776183875·Lightweight Combination Mallet oz diameter len...
n/a
FDA UDI
Ortho Development Corporation·00822409076123·Femoral Broach/Trial 1421
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450457870·
MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708; 851318704-708, 131218204
FDA 510(k)
FDA Class 2
·Orthopedic
DISPOSABLE INSULIN SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·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
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·July 22, 2014
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
Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 2015
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 L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025