13 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Sclerotherapy Needle
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Bernafon
FDA UDI
Bernafon AG·05711584114346·AN3, BTE SP 2.4G NFM MSIL ALTENA 3 GPL
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704514506·
Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable Protein
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
RAICHEM GLUCOSE UV REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GALILEO® LAG SCREW INSERTER
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HSB·June 19, 2024
GALILEO® LOCKING TOOL
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HSB·October 16, 2024
130° RADIOLUCENT TARGETING ARM
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HSB·August 12, 2024
FG 6301 DUAL CHNL VOL INF PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·October 29, 2008
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·August 16, 2011
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 9, 2013
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 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.·May 3, 2017
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021