18 results · 21ms · Sources: EU EUDAMED, US FDA

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Electronic Blood Pressure Monitor

FDA 510(k)
FDA Class 2 ·Cardiovascular

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·07613153171089·SCREWDRIVER BLADE, 1.2MM

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·07613153171126·Screwdriver Blade 1.2mm Upper-Face

CADD

FDA UDI
ICU MEDICAL, INC.·30610586034583·

MS SA IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS

FDA 510(k)
FDA Class 2 ·Cardiovascular

VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR, MEDIUM

FDA Adverse Event
Malfunction ·CONMED CORPORATION·Product code LKF·February 22, 2013

ECAREMANAGER V3.6

FDA Adverse Event
Malfunction ·VISICU·Product code MSX·September 21, 2009

ECAREMANAGER V3.6

FDA Adverse Event
Malfunction ·VISICU·Product code MSX·December 14, 2009

INTERSTIM

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code EZW·October 29, 2014

LTV

FDA Adverse Event
Malfunction ·CAREFUSION 203, INC·Product code CBK·July 8, 2011

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·July 8, 2013

VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR, MEDIUM

FDA Adverse Event
Malfunction ·CONMED CORPORATION·Product code LKF·March 1, 2013

CEFALY

FDA Adverse Event
Injury ·CEFALY TECHNOLOGY·Product code PCC·March 9, 2026

CEFALY

FDA Adverse Event
Injury ·CEFALY TECHNOLOGY·Product code PCC·March 9, 2026

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·July 7, 2021

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

Model Number L211 PROPONENT DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025