14 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C
FDA 510(k)
FDA Class 1
·Dental
ConMed
FDA UDI
Provision·B504OM50713530·
Reprocessed Oscillating Saw Blade Coated, 13 x 70 x 1.19mm
FDA UDI
SURETEK MEDICAL·B39050713531·
INTREX
FDA UDI
Conmed Corporation·10845854009345·INTREX LARGE BONE OSCILLATING SAW BLADE 13.0 X ...
ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
XIA 3 TITANIUM BLOCKER
FDA Adverse Event
Malfunction
·STRYKER SPINE-SWITZERLAND·Product code MNI·January 21, 2016
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 7, 2025
ACCU-CHEK ® INFORM METER
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·April 22, 2013
UNKNOWN DEPUY ACETABULAR LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·April 13, 2011
LIFESHIELD SECONDARY SET WITH CONV PIN
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPA·July 8, 2008
Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·February 28, 2018
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012