58 results · 23ms · Sources: EU EUDAMED, US FDA

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ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)

FDA 510(k)
FDA Class 2 ·Cardiovascular

ASAHI GLADIUS EX

FDA Adverse Event
Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·September 17, 2025

ASAHI GLADIUS EX

FDA Adverse Event
Injury ·ASAHI INTECC CO., LTD.·Product code DQX·April 13, 2026

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526768499·GENUMEDI PSS GREEN V

HHM

FDA UDI
Oticon A/S·05707131288905·H110V2 TI, RITE 312 WL SIL HHM

OSS™ Orthopedic Salvage System

FDA UDI
Biomet Orthopedics, LLC·00880304239661·

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100127·KRATZ-BARRAQUER SPECULUM RIGHT EYE

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100134·KRATZ-BARRAQUER SPECULUM LEFT EYE

Tibial Ultra+ Trial Insert Size 4

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215073916·

AMS COLLAGEN DERMAL MATRIX

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

KLASSIC HD HIP SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

OBTRYX SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 6, 2013

INTELLIVUE MULTI MEASUREMENT SERVER X2

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·June 8, 2011

GE OEC 9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008

Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;

FDA Enforcement
Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·April 8, 2026

MOD ARTHRO 0 DEG LCK COLLAR

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code HSB·October 28, 2021

ORTHOPEDIC SALVAGE SYSTEM RS POLYETHYLENE FEMORAL BUSHINGS

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KRO·February 18, 2019

ORTHOPEDIC SALVAGE SYSTEM CEMENTED PROXIMAL TIBIAL STEM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDI·February 18, 2019

ORTHOPEDIC SALVAGE SYSTEM POLYETHYLENE TIBIAL BUSHING

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDI·February 18, 2019

ORTHOPEDIC SALVAGE SYSTEM 4CM DIAPHYSEAL SEGMENT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDI·February 18, 2019