17 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DRPx Locking Distal Radius Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
Bernafon
FDA UDI
Bernafon AG·05711584115404·CO3 MNR T, 2.4G NFM MSIL CAPTO 3 GPL
Richard-Allan® Needle 1/2 Circle Taper
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00840113217045·Intent to be used with suture material for tiss...
VERIDIAN
FDA UDI
VERIDIAN HEALTHCARE LLC·00845717000390·ProKit Aneroid Sphygmomanometer With Sprague Sc...
Cal OSHA - 18 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588026015·Cal OSHA - 18 Metal
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383514996·"An absorbent paper points is an endodontic pap...
TLC Uni Knee Meniscal Insert
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215077709·
Remedy Instrument Case
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215040178·
INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER
FDA 510(k)
FDA Class 2
·Cardiovascular
CLEARMEDICAL/AIRCAST VENAFLOW CALF CUFF, CLEARMEDICAL AIRCAST XL VENAFLOW CALF CUFF, CLEARMEDICAL/AIRCAST VENAFLOW THIGH
FDA 510(k)
FDA Class 2
·Cardiovascular
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·October 24, 2008
UNKNOWN ZIMMER ACETABULAR LINER
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KWB·August 11, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 9, 2013
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
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
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023
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