23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Verifine Safety Type Insulin Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036034191·
Dilator, Vascular, acc. Geister 15cm 3.0mm alu-handle PURPLE
FDA UDI
Geister Medizintechnik GmbH·04057034046074·Dilator, Vascular, acc. Geister
15cm 3...
Salvo® Spine System
FDA UDI
Spine Wave, Inc.·10840642174670·9.5 x 80 mm Bone Screw, Cannulated, 3 mm Pitch
EXPLOR
FDA UDI
Biomet Orthopedics, LLC·00880304210486·
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869610858·MOSS VRS Ti rod, Ø5.5x65mm, curved
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869604109·MOSS Ti Rod, Ø5.5x65mm curved
Dilator, Vascular, acc. Geister 15cm 3.0mm alu-handle PURPLE
FDA UDI
Geister Medizintechnik GmbH·04057034046081·Dilator, Vascular, acc. Geister
15cm 3...
RIVA Posterior Fixation System
FDA UDI
XENIX MEDICAL LLC·00840493415567·Open Lateral Connector, 65mm
SPAULDING IQ ELECTROCARDIOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
CRANIAL STEREOTACTIC EQUIPMENT
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 22, 2024
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code FZP·October 22, 2008
BIOLOX
FDA Adverse Event
Other
·ZIMMER GMBH·Product code LZO·July 25, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 3, 2013
XVWEB
FDA Adverse Event
Injury
·PLANET DDS·Product code LLZ·March 13, 2025
SECOND OPINION
FDA Adverse Event
Injury
·PEARL INC.·Product code MYN·March 13, 2025
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 19, 2023
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 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
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014