11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Triever16 Curve
FDA 510(k)
FDA Class 2
·Cardiovascular
INNOVATIVE MEDICAL PRODUCTS, INC.
FDA registration
INNOVATIVE MEDICAL PRODUCTS, INC.·10 products·🇺🇸 United States
TRILAMINATE DRAPES/TIBURON
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EVA SELECT DIGITAL DENTAL IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Dental
LNCS
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·August 18, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 4, 2014
PINNACLE SECTOR II CUP 52MM
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·July 12, 2013
Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 2015
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
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026