19 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sniper Spine System
FDA 510(k)
FDA Class 2
·Orthopedic
Orthopedic Salvage System (OSS)
FDA UDI
Biomet Orthopedics, LLC·00880304674363·
ProLift
FDA UDI
Life Spine, Inc.·00190837138431·
Apex Connect
FDA UDI
META SYSTEMS CO., LTD.·08809455601990·Apex Connect Lip Hook
CUSA EXCEL 36KHZ TUBING SET
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES (IRELAND) LTD.·Product code LFL·November 25, 2015
ULTRAPACS
FDA 510(k)
FDA Class 2
·Radiology
IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO
FDA 510(k)
FDA Class 2
·Radiology
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180529096·MICROSCOPE DP - LIF, ENDPLATE SCRAPER, STRAIGHT...
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180529089·MICROSCOPE DP - LIF, ENDPLATE SCRAPER, STRAIGHT...
ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026
PERMAFIX FIXATION SYSTEM
FDA Adverse Event
Malfunction
·BARD-DAVOL·Product code GDW·June 3, 2013
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code MCX·July 6, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
D902 LILLIPUT ECMO M PHISIO
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 7, 2022
LILLIPUP PMP, LILLIPUT PMP INTEGRATED
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·June 27, 2022
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151813
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code JDI·July 2, 2019
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151813
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·August 21, 2019
TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.
FDA Recall
Terminated
·Theralase Inc.·Product code NHN·September 26, 2019
TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
FDA Recall
Terminated
·Theralase Inc.·Product code NHN·September 26, 2019