17 results · 19ms · Sources: EU EUDAMED, 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