16 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Remi Robotic Navigation System
FDA 510(k)
FDA Class 2
·Neurology
Kitazato ET Catheter
FDA UDI
KITAZATO CORPORATION·04580745041149·
Universal Wrist Lacer II
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357233502·
Orthopedic Instruments
FDA UDI
GM DOS REIS INDUSTRIA E COMERCIO LTDA·07899258637334·
Votion®
FDA UDI
Ortho Organizers, Inc.·00190707114022·Votion .022 MC(0T) LR3 HK 0T 3A 0O (10PK)
Pinnacle®
FDA UDI
Ortho Organizers, Inc.·00190707112110·Pinnacle .022 MC(0T) LR3 HK 0T 3A 0O (10PK)
Votion
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730008336·Votion .022 MC(0T) LR3 HK 0T 3A 0O (10PK)
Marquis
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730012562·Marquis MBT 022 LR3 Hk Rx 0 Tor +3 Ang (10PK)
Pinnacle
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730010162·Pinnacle .022 MC(0T) LR3 HK 0T 3A 0O (10PK)
ECLIPSE SOFT TISSUE FASTENER
FDA 510(k)
FDA Class 2
·Orthopedic
ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS
FDA 510(k)
FDA Class 2
·Anesthesiology
BMHR MODULAR HEAD 54MM
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·December 12, 2018
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 4, 2014
ALARIS
FDA Adverse Event
Malfunction
·ALARIS·Product code FRN·August 11, 2011
OT VERIO PRO PLUS METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2013
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