18 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON
FDA 510(k)
FDA Class 2
·Orthopedic
DP-REPAIR
FDA UDI
Denplus Inc·D8451071107·DP-REPAIR-F, MDP, 454 g
NA
FDA UDI
KEY SURGICAL, INC.·10849771048906·K-Wires, Double trocar, .045-inch (1.1mm) diame...
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659484085·K-Wire w. double end trocarpoint _x000D_...
K-Wire w. double end trocarpoint 1.10mm/127mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM711070·K-Wire w. double end trocarpoint
1.10mm...
CONMED
FDA UDI
Conmed Corporation·10845854002063·GRAFT HARVESTING BLADE 7 X 20 MM
NA
FDA UDI
STERILMED, INC.·10888551017879·SAW BLADE GRAFT HARVESTING LARGE BONE
MODIFICATION TO SOLO
FDA 510(k)
FDA Class 2
·Physical Medicine
FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 20, 2021
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 13, 2021
BLADE 22.5 DEG S/SU SLATE BL (5/SP)
FDA Adverse Event
Malfunction
·BEAVER-VISITEC INTERNATIONAL, INC.·Product code HNN·August 14, 2025
LINEAR 3-6
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 3, 2020
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 22, 2013
MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 27, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·July 10, 2008
BD TEXIUM¿ NEEDLE-FREE SYRINGE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FMF·November 29, 2022
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012