18 results · 28ms · Sources: EU EUDAMED, US FDA

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da Vinci Single-Site Instrument and Accessories

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

K152468

FDA UDI
Shenzhen Vistar Medical Supplies Co.,Ltd.·96973521874184·Reusable NIBP cuff,Thigh,single tube, HP connector

PILLING

FDA UDI
TELEFLEX INCORPORATED·24026704508819·

OsteoMed

FDA UDI
OSTEOMED LLC·00842528127735·2.4 X 48mm Cannulated Headless Screw, T7

Low Profile Acetabular Reamer 48

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215057510·

PULSIOFLEX

FDA 510(k)
FDA Class 2 ·Cardiovascular

POCKET BREATHALYZER. CONNECTABLES

FDA 510(k)
FDA Class 1 ·Clinical Toxicology

VERSYS FEMORAL STEM

FDA Adverse Event
Injury ·ZIMMER INC·Product code LPH·February 25, 2016

BD POSIFLUSH¿ NORMAL SALINE SYRINGE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·September 1, 2022

S-ICD SYSTEM

FDA Adverse Event
Injury ·CAMERON HEALTH·Product code LWS·June 24, 2014

DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

FDA Adverse Event
Malfunction ·RICE CREEK MFG·Product code LWS·June 7, 2013

LEAD MODEL UNKNOWN

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code MUZ·June 22, 2011

INFINION CX

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 31, 2023

Precise Treatment Table. To be used as part of radiation therapy treatment process.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·April 17, 2013

All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·March 12, 2014

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025