22 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Bur PM2-70 80K Carb Ø4.0 St
FDA UDI
Bien-Air Surgery SA·17630055503654·
TMA - Archwire
FDA UDI
ORMCO CORPORATION·00889989027020·TMA BROAD ARCH UP SML 0175 0175 PK/10
OsteoMed
FDA UDI
OSTEOMED LLC·00845694028448·ISO Chin Plate, 8mm
Dynamic Axial Fixator
FDA UDI
ORTHOFIX SRL·18033509856082·DRILL BIT D.1,6 MM L.90 MM TIN COATED - QUICK C...
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869604918·Rod Holding Forceps Ø4.5-6.0mm
VAPOTHERM, MODEL 2000I
FDA 510(k)
FDA Class 2
·Anesthesiology
TRI-PLEX ADAPTER
FDA 510(k)
FDA Class 2
·Anesthesiology
ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01
FDA 510(k)
FDA Class 2
·Orthopedic
ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01
FDA 510(k)
FDA Class 2
·Immunology
ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01
FDA 510(k)
FDA Class 2
·Immunology
EVIS EXERA II COLONOVIDEOSCOPE
FDA Adverse Event
Injury
·AIZU OLYMPUS CO., LTD.·Product code FDF·November 20, 2024
MAMBA? FLEX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·September 11, 2025
FLOGARD
FDA Adverse Event
Malfunction
·SHARP CORPORATION OSAKA JAPAN·Product code FRN·May 8, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 18, 2014
8800
FDA Adverse Event
Malfunction
·GE MED SYSTEMS (INDIA) PRIVATE LTD.·Product code JAA·May 13, 2011
PIRANHA
FDA Adverse Event
Injury
·RICHARD WOLF GMBH·Product code JCX·January 5, 2022
Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code CCX·July 23, 2021
Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
FDA Enforcement
Class II
·Terminated·Aspen Surgical Products, Inc.·September 8, 2021
Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781315
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021