13 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CoRoent
FDA UDI
Nuvasive, Inc.·00887517569943·CoRoent Ant TLIF Ti, 12x13x30mm 4°
Tripod Wrist Lacer
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357233045·
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551077207·Sickle Knife, very delicate
16PW - PG&E Class A 21
FDA UDI
Certified Safety Manufacturing, Inc.·00766588233048·16PW - PG&E Class A 21
Orthopedic Instruments
FDA UDI
GM DOS REIS INDUSTRIA E COMERCIO LTDA·07899258637112·
SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIO
FDA 510(k)
FDA Class 2
·Dental
IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYMBIQ
FDA Adverse Event
Malfunction
·HOSPIRA·Product code FRN·August 9, 2011
RIATA PASSIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
OT VERIO PRO PLUS METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018