21 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CalcaNail Orthopedic Arthrodesis Nail
FDA 510(k)
FDA Class 2
·Orthopedic
ECG Module(AHA)
FDA UDI
SAMSUNG MEDISON CO., LTD.·08806167712532·
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768451·GENUMEDI PSS GREEN I
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304239920·
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100196·MCINTYRE SPECULUM OPEN WIRE
IM Rod 200mm
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215041472·
BABI PLUS INFANT NASAL CANNULA SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RADIFOCUS GLIDEWIRE M
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 22, 2018
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 6, 2013
BARDEX I.C.
FDA Adverse Event
Malfunction
·BARD·Product code KOD·June 23, 2011
COMPOSIX MESH
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·September 5, 2008
UNKNOWN OSS FEMUR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 3, 2017
ORTHOPAEDIC SALVAGE SYSTEM NON-MONDULAR TIBIAL PLATE LONG 67
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·July 29, 2024
ORTHOPAEDIC SALVAGE SYSTEM TIBIAL POLY BEARING 12MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·July 29, 2024
ORTHOPEDIC SALVAGE SYSTEM FINN MODULAR PROXIMAL FEMORAL COMPONENT RIGHT 7CM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·June 11, 2025
ORTHOPEDIC SALVAGE SYSTEM CEMENTED PROXIMAL TIBIAL STEM 13MM X 150MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·June 11, 2025
MICRUSFRAME10 5MM X 9.7CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·April 23, 2021
ZIMMER COMPRESS HA ANTI ROTATION SPINDLE SHORT LARGE 44MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·September 15, 2017
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015