17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Diode Laser Therapy Systems
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VERSALOOP™ Anchor 2 Tape, 1.8mm
FDA UDI
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION·10818674024782·
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319744550·Adson Dura & Dissecting Hook 8" (20cm), sharp b...
Dilator, Vascular, acc. Garrett 35cm 4.0mm
FDA UDI
Geister Medizintechnik GmbH·04057034047576·Dilator, Vascular, acc. Garrett
35cm 4...
Savant Lumbar Interbody Fusion System
FDA UDI
CURITEVA, INC.·B648C30422101680·PEEK PLIF Spacer, 22 x 10 x 16mm, 8 deg
Savant Lumbar Interbody Fusion System
FDA UDI
CURITEVA, INC.·B648C31422101680·Titanium PLIF Spacer, 22 x 10 x 16mm, 8 deg
ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE
FDA 510(k)
FDA Class 3
·Cardiovascular
LULLABY LED PHOTTHERAPY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
OT ULTRAMINI METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE GMBH·Product code NBW·June 26, 2019
COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·July 3, 2013
TRUEMETRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·April 11, 2018
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 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
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