17 results · 20ms · Sources: EU EUDAMED, 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