15 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Clear Aligner
FDA 510(k)
FDA Class 2
·Dental
NA
FDA UDI
Synthes GmbH·10886982157799·3.5MM MEDIAL DISTAL TIBIA PLATE 16 HOLES/225MM-...
Empower Clear
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746000966·COSMETIC SL EMPOWER CLEAR INTERACT LL 2ND BICUS...
Empower Clear Bracket
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746200465·COSMETIC SL EMPOWER CLEAR INTERACT LL 2ND BIC 0...
Empower Clear Bracket
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746200823·COSMETIC SL EMPOWER CLEAR PASSIVE LL 2ND BIC 02...
Empower Clear
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746154621·COSMETIC SL EMPOWER CLEAR INTERACT LL 2ND BIC 0...
Empower Clear
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746060595·COSMETIC SL EMPOWER CLEAR PASSIVE LL 2ND BIC 02...
DERMAGRIP-P POWDER FREE PINK NITRILE EXAMINATION GLOVES, NON-STERILE
FDA 510(k)
FDA Class 1
·General Hospital
GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·July 14, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 4, 2014
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 12, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026