22 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ANKYRAS
FDA 510(k)
FDA Class 2
·Radiology
Vivid PMMA Standard System
FDA UDI
PEARSON DENTAL SUPPLIES, INC.·D724Q2501601·98x22 A2
BD Directigen™ Neisseria meningitidis Test Kit Groups A, C, Y and W135
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902501602·BD Directigen™ Neisseria meningitidis Test Kit ...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776183141·Hibbs Osteotome . Cvd
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192619·Distal Reamer 16mm (Zimmer)
Monkey Rings™ External Fixation System
FDA UDI
Paragon 28, Inc.·00889795129512·5/6 TAB RING, Ø160mm
Stainless Steel Archwire
FDA UDI
Ortho Arch Company Inc·D90925016011·.017 X .022 UPPER SS RIGHT FORM ARCHWIRES (10)
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780188186·Integra® Jarit® Hibbs Osteotome, 9-1/2", Curved...
KATANA ZIRCONIA
FDA 510(k)
FDA Class 2
·Dental
Temple Touch Pro (TTP) Non-invasive temperature monitoring system
FDA 510(k)
FDA Class 2
·General Hospital
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197313360·Aufricht nasal retractor
10x45 ...
ONE TOUCH II
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·February 4, 2002
JARIT 250-160
FDA Adverse Event
Malfunction
·JARIT·Product code GFI·September 12, 2017
SENSOR MMT-7020A ENLITE3 5PK US
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·June 20, 2018
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·June 20, 2018
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 25, 2019
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 15, 2011
PREFYX PPS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code FTL·July 26, 2013
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 22, 2013
MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·February 25, 2026