58 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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