14 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DR Safety Syringe, Sterile Hypodermic needle for Single use
FDA 510(k)
FDA Class 2
·General Hospital
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704514216·
NA
FDA UDI
Synthes GmbH·10886982152336·5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE...
Fibula Plate PROlock
FDA UDI
I.T.S. GmbH·09120034302633·Fibula Plate PROlock, 6-Hole, Left
MONITORING SYSTEM,MODEL ARGUS PB-1000
FDA 510(k)
FDA Class 2
·Cardiovascular
HYDROCOIL EMBOLIC SYSTEM (HES)
FDA 510(k)
FDA Class 2
·Neurology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·December 28, 2020
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 30, 2014
ENDOPATH** XCEL* TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·August 15, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2013
MEDTRONIC LEAD
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DXY·March 25, 2025
LIFEVEST WCD 3100 SYSTEM
FDA Adverse Event
Injury
·ZOLL MANUFACTURING CORPORATION·Product code MVK·May 6, 2015
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015