17 results
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29ms
·
Sources: EU EUDAMED, US FDA
Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112861·CORNEAL TREPHINE BLADE6.0MM
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192213·Apex Revision Knee Reamer – ZIMMER SHORT FLUTES...
ELDON BAG 2521-50
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Eldon Biologicals A/S·On the market
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197449533·Antrum Punch, 65° forward cutting,
upward...
VOLAR PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
V8 Balloon Aortic Valvuloplasty Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 7, 2020
INSYTE AUTOG BC BLU 22GA X 1.0IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 3, 2021
RESERVOIR 1.8ML
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·November 14, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 16, 2011
TWIST DRILL
FDA Adverse Event
Injury
·KARL LEIBINGER MEDIZINTECHNIK GMBH U. CO. KG·Product code HTW·July 25, 2013
IMP,TSV,4.1MM,SBM,10
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·September 9, 2022
ELDON BAG 2521-50
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Eldon Biologicals A/S·1 device
BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 2, 2021
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026