18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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