23 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIAC
FDA 510(k)
FDA Class 2
·Radiology
JOBST SensiFoot
FDA UDI
BSN MEDICAL, INC.·00035664108403·SENSIFOOT 8-15 MM HG CREW EXTRA SMALL BROWN 1 E...
LoFric® Primo™
FDA UDI
Wellspect AB·07333387043050·Single Use Urinary Catheter LoFric Primo Nelato...
LoFric® Primo™
FDA UDI
Wellspect AB·07392532135439·Single Use Urinary Catheter LoFric Primo Nelato...
Medetz Surgical Instruments
FDA UDI
Medetz Surgical Instruments LLC·G2231108400·Golf Club Spud, delicate Serrated Handle, OL120...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306818950·Yu-Holtgrewe Retractor, Simpson Handle, 6.35cm ...
Posted Stainless Steel Archwire
FDA UDI
Ortho Arch Company Inc·D90911084011·.018 X .025 POSTED SS RIGHT FORM WIRES 40MM (10)
SYNPLUG
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EMBO PLUS EMBOLECTOMY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
AMISTEM H HA COATED STEM SIZE 7
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 29, 2019
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 7, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 13, 2026
STEM: AMISTEM H HA COATED STD STEM SIZE 7
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 29, 2019
ENDEAVOR SPRINT RX
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code NIQ·May 14, 2013
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·September 23, 2014
UNICEL® DXC 800 PRO SYNCHRON ® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·June 2, 2011
INTELLIS
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LGW·August 23, 2022
Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·May 16, 2018
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025