21 results · 23ms · Sources: EU EUDAMED, 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