19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION
FDA 510(k)
FDA Class 2
·General Hospital
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780157014·Integra® Jarit® Suction Valve For 600-340 & 630...
SCANLAN® Needle Holders
FDA UDI
SCANLAN INTERNATIONAL INC·00846159003185·Mayo-Hegar Needle Holder Diamond Dust™ Jaw
4.0 X 34mm CANN SCREW FASTENER Ti LG THD
FDA UDI
Osteocentric Technologies, Inc.·00810074303507·4.0 X 34mm CANN SCREW FASTENER Ti LG THD
SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST
FDA 510(k)
FDA Unclassified
·Unknown
VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·May 22, 2015
JUGGERSTITCH MENISCAL REPAIR DEVICE CURVED
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code MBI·February 13, 2026
JUGGERSTITCH MENISCAL REPAIR DEVICE CURVED
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code MBI·February 13, 2026
LTV
FDA Adverse Event
Malfunction
·CAREFUSION 203 INC·Product code CBK·February 13, 2013
FOLFUSOR SV 4ML/H
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·March 1, 2011
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code LTJ·February 13, 2008
PENUMBRA COIL 400
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·March 10, 2017
PROXICOR FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·AZIYO BIOLOGICS, INC.·Product code DXZ·June 26, 2020
TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·August 5, 2015
WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·May 3, 2017
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013