19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017699·K-Wire, Double Ended, Trocar Point, Diameter Si...
Connector Holding Forceps
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215068479·
PENTA
FDA Adverse Event
Injury
·GUIDANT VASCULAR INTERVENTION·Product code MAF·January 25, 2002
CASPIAN Spinal System
FDA UDI
VB Spine LLC·10888857242159·Distractor
GALAXY LITE
FDA 510(k)
FDA Class 1
·Physical Medicine
MODIFICATION TO THERMAL ANGEL
FDA 510(k)
FDA Class 2
·Hematology
WAVEWRITER ALPHA PRIME 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 29, 2024
PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code KWI·January 25, 2017
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 7, 2013
XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·September 23, 2014
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·June 2, 2011
8MM TI STRAIGHT RADIAL STEM 28MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWI·January 24, 2017
22MM COCR RADIAL HEAD STANDARD HEIGHT/12.5MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWI·January 24, 2017
18MM COCR RADIAL HEAD STANDARD HEIGHT/11.5MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWI·September 7, 2017
7MM TI STRAIGHT RADIAL STEM 26MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWI·September 7, 2017
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 L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025