27 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Modulith SLX-F2
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169631526·TRAY 2201001 PIVOX INSTRUMENT SET 2
OsteoMed
FDA UDI
OSTEOMED LLC·00845694019125·1.2mm/1.6mm Plate Holding Tak
Eargo SE
FDA UDI
Eargo, Inc.·00850010429847·Eargo SE UHC and Travel Case
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869611770·MOSS VRS vertebral realignment sleeve
OneLIF™
FDA UDI
Novapproach Spine LLC·G07001312010010·Retention Plate, Anterior-Only, Small, 10 mm
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523130276·Knee Instrument Case 1 Caddy
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523130269·Knee Instrument Case 1 Tray
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523130252·Knee Instrument Case 1 Base
SHANGHAI GLOVMAX ENTERPRISE POWDERFREE BLUE NITRILE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01
FDA 510(k)
FDA Class 2
·Radiology
QUICK SET PARADIGM
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 6, 2010
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 27, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 11, 2011
TITANIUM BONE SCREWS, DIAM.2.7X16MM, CROSS-PIN, SELF-TAPPING, (5/PACKAGE)
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS-FREIBURG·Product code HRS·July 2, 2013
LOW PROFILE REAMER, 11MM
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code HTO·February 15, 2023
A200 KNEE SYSTEM
FDA Adverse Event
Injury
·RENOVIS SURGICAL TECHNOLOGIES, INC.·Product code JWH·September 16, 2016
A200 KNEE SYSTEM
FDA Adverse Event
Injury
·RENOVIS SURGICAL TECHNOLOGIES, INC.·Product code JWH·September 16, 2016
Quanta System Sterile Optical Laser Fiber, single use
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·June 16, 2021