18 results
·
35ms
·
Sources: EU EUDAMED, US FDA
PROMO-RIST C.P.M.
FDA 510(k)
FDA Class 1
·Physical Medicine
Archon
FDA UDI
Nuvasive, Inc.·00887517310064·Archon Screw, 4.0x14mm S.T. Fixed
Sunshine Diamonds
FDA UDI
Dr. Hopf GmbH & Co. KG·ESUNA8813140125·Rotary diamond instruments
Sunshine Diamonds
FDA UDI
Dr. Hopf GmbH & Co. KG·ESUNT8813140125·Rotary diamond instruments
Sunshine Diamonds
FDA UDI
Dr. Hopf GmbH & Co. KG·ESUNA8813140122·Rotary diamond instruments
Sunshine Diamonds
FDA UDI
Dr. Hopf GmbH & Co. KG·ESUNA8813140142·Rotary diamond instruments
Sunshine Diamonds
FDA UDI
Dr. Hopf GmbH & Co. KG·ESUNA8813140105·Rotary diamond instruments
Sunshine Diamonds
FDA UDI
Dr. Hopf GmbH & Co. KG·ESUNT8813140122·Rotary diamond instruments
Sunshine Diamonds
FDA UDI
Dr. Hopf GmbH & Co. KG·ESUNA8813140102·Rotary diamond instruments
Sunshine Diamonds
FDA UDI
Dr. Hopf GmbH & Co. KG·ESUNA8813140145·Rotary diamond instruments
NA
FDA UDI
STRYKER CORPORATION·07613327055511·[Cutting Loop Electrode, .014 wire, 27 Fr ¿ 90 ...
THERAPY UNIT & ELECTRODIAG.
FDA 510(k)
FDA Class 2
·Neurology
IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension
FDA 510(k)
FDA Class 2
·Cardiovascular
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 18, 2014
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·October 7, 2010
EON
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 17, 2012
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020
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