20 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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ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10885380077357·1.1mm Non-Threaded Guide Wire 150mm
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317328472·
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122223·KWire .045x6" (1.1x150mm)
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213033610·Coupling Treatment Tube for 4F Flexibles (28)
StaXx® XD System
FDA UDI
Spine Wave, Inc.·10840642100167·Cartridge Lordotic Expandable Implant Ti 22x9x7...
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122216·KWire .045x6" (1.1x150mm) Threaded
RESORB-X RESORBABLE PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Dental
DIGITAL FLAT PANEL X-RAY DETECTOR
FDA 510(k)
FDA Class 2
·Radiology
WAVEWRITER ALPHA? PRIME 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 26, 2026
EQUINOXE PRESERVE STEM 8MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·October 28, 2025
3.5MM LCP SUPERIOR CLAVICLE PLATE/7 HOLE/RIGHT/100MM
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HRS·August 15, 2017
RING ANNULOPLSTY TRICUSP CONTOUR 3D 26MM
FDA Adverse Event
Death
·HEART VALVES SANTA ANA·Product code KRH·May 14, 2013
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·September 23, 2014
FLEXICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·June 2, 2011
XP-CR Tibial Tray - Interlok 71mm Item # 195273
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
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
ACCOLADE DR EL MRI (Model L331)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811 11-162812 11-162813 21-103202 21-103203 21-103204 21-103205 21-103206 21-103207 21-103208 21-103209 21-103210 21-103211 21-103212 21-103215 21-104109 21-104110 21-104111 21-104112 21-104113 21-104114 21-104115 21-104116 21-104117 21-104118 21-104119 21-108110 21-108112 21-108115 21-108117 21-108119 21-108130 21-108132 21-108135 21-108137 21-108139 21-108150 21-108152 21-108155 21-108157 21-108159 21-108251 21-108253 21-108255 21-108257 21-108259 21-108271 21-108273 21-108275 21-108277 21-108279 21-108291 21-108293 21-108295 21-108297 21-108299 21-108391 21-108393 21-108395 21-108397 21-108399 21-109256 21-109260 21-109264 21-109268 21-109272 21-123202 21-123203 21-123204 21-123205 21-123206 21-123207 21-123208 21-123209 21-123210 21-123211 21-123212 21-124309 21-124310 21-124311 21-124312 21-124313 21-124314 21-124315 21-124316 21-124317 US157338 US157340 US157342 US157344 US157346 US157348 US157350 US157352 US157354 US157356 US157358 US157359 US157360 X21-180307 X21-180308 X21-180309 X21-180310 X21-180311 X21-180312 X21-180313 X21-180314 X21-180315 X21-180316 X21-180317 X21-180318 X21-180319 X21-180320 X21-180321 X21-182308 X21-182309 X21-182310 X21-182311 X21-182312 X21-182313 X21-182314 X21-182315 X21-182316 X21-182317 X21-182318 X21-182319 X21-182320 X21-182321 Product Usage: Hip arthroplasty.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019