15 results
·
20ms
·
Sources: EU EUDAMED, US FDA
AONGEN DENTAL COLLAGEN MATRIX
FDA 510(k)
FDA Unclassified
·Unknown
4900 7L SYRINGE
FDA UDI
HANS RUDOLPH, INC.·00874750009107·4900D 7L SYR 1.125/22MM OUTLET
URIC ACID MODEL 3P39
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GE VISION NUCLEAR MEDICINE WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
DREAMSTATION AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·February 13, 2023
AWL Ø2 ANGL
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code OVE·January 8, 2013
AWL Ø2 ANGL
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code OVE·January 7, 2013
AWL Ø2 ANGL
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code OVE·January 7, 2013
FUSION¿ ENT NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 2, 2019
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·May 14, 2013
PFC PLI 10MM SZ3
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·May 19, 2011
ECHELON 60 ENDOPATH STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 11, 2008
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025