526 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Cemented TSI Hip Stem
FDA 510(k)
FDA Class 2
·Orthopedic
Bernafon
FDA UDI
Bernafon AG·05711584086988·ZR3, KIT 13 2.4G NFM R BE ZERENA 3
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776408589·LLETZ W-GRAV 45* R MD E/T 4" (10.2CM) LLETZ WEI...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694015356·2.0mm x 24mm Cannulated Lag Screw
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668110966·STERILIZING CASE 4-KNIVES
OsteoMed
FDA UDI
OSTEOMED LLC·00845694070300·Cannulated 2.0 x 24mm Lag Screw Sterile Qty 5
TI-MAX X450
FDA 510(k)
FDA Class 1
·Dental
RPM RESPIRATORY GATING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ARTICUL/EZE BALL 28+8.5 BL
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code JDI·October 6, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·June 20, 2013
NSK
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code EFB·December 6, 2018
NSK
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code EFB·December 6, 2018
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
DISKOM
FDA Adverse Event
Injury
·BIOPSYBELL SRL·Product code HRX·April 3, 2024
NIMBUS II PLUS AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·INFUTRONIX, LLC·Product code FRN·March 23, 2024
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·February 11, 2020
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
HAMILTON-G5
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·March 13, 2025
MONARCH Bronchoscope. Model Number: MBR-000211-B
FDA Enforcement
Class II
·Ongoing·Auris Health, Inc·November 26, 2025