18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION
FDA 510(k)
FDA Class 2
·Orthopedic
ComfortGel
FDA UDI
Respironics, Inc.·00606959022157·
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290114694797·Step Drill Ø2.4/3.2mm, Long
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108690651·Titanium Anatomic Angulated Concave Abutment In...
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108691832·Step Drill Ø2.4/3.2mm, Long
PERSONA® Persona SoluTion™
FDA UDI
Zimmer, Inc.·00889024231658·
PERSONA® Persona SoluTion™
FDA UDI
Zimmer, Inc.·00889024231665·
X-RAY MONOBLOCK, MONOBLOCK XRS-60-330
FDA 510(k)
FDA Class 1
·Radiology
RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 29, 2024
STELLARIS ELITE VISION ENHANCEMENT SYSTEM
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code HQC·March 1, 2022
25 GA POSTERIOR WIDE-FIELD ELITE PACK
FDA Adverse Event
Malfunction
·BAUSCH + LOMB, INC·Product code HQC·December 6, 2019
LCP MED-DIST-TIBIAL PL 3.5 LOW BEND LE 6
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HRS·April 22, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 26, 2011
AUTOCAT2 WAVE
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·July 3, 2008
STELLARIS POWER SUPPLY II
FDA Adverse Event
Malfunction
·BAUSCH + LOMB·Product code HQC·August 1, 2023
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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