15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PSLT for PASCAL Streamline
FDA 510(k)
FDA Class 2
·Ophthalmic
ORTHO SUMMIT TM SAMPLE HANDLING SYSTEM
FDA Adverse Event
Other
·HAMILTON BONADUZ AG·Product code JTC·October 7, 1997
MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003
FDA 510(k)
FDA Class 2
·Cardiovascular
REALHAND HIGH DEXTERITY (HD) INSTRUMENTS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·June 30, 2011
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 17, 2008
FREEDOM ALL POLY CUP 54MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWZ·December 2, 2024
PERFORMER MULLINS GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·January 20, 2023
PERFORMER MULLINS GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·January 24, 2024
CPT 12/14 SZ 4 COCR 230MM EXT
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code JDI·November 27, 2024
FREEDOM CONSTRAINED HEAD 12/14 TAPER 36 MM DIAMETER +0 MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·November 27, 2024
PERFORMER INTRODUCER
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·November 4, 2022
BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·January 13, 2016
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·October 27, 2021