11 results · 20ms · Sources: EU EUDAMED, 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