18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NC° Thermometer (Gen 3), Model Number: NCTG3
FDA 510(k)
FDA Class 2
·General Hospital
ZESPIN SI Joint Fusion System
FDA UDI
Aegis Spine, Inc.·00840273321590·Locking Screw Ø8x55mm
ENDER NAIL
FDA UDI
Smith & Nephew, Inc.·03596010104342·3.5MM DIAMETER NAIL 3.5MMX22CM
...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694021340·FPS 3.5mm x 22mm Locking Screw
Empower Clear
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746154645·COSMETIC SL EMPOWER CLEAR INTERACT LL 2ND BIC 0...
Empower Clear
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746060618·COSMETIC SL EMPOWER CLEAR PASSIVE LL 2ND BIC 02...
Empower Clear Bracket
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746200847·COSMETIC SL EMPOWER CLEAR PASSIVE LL 2ND BIC 02...
Empower Clear Bracket
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746200489·COSMETIC SL EMPOWER CLEAR INTERACT LL 2ND BIC 0...
Empower Clear
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746000980·COSMETIC SL EMPOWER CLEAR INTERACT LL 2ND BICUS...
OPTIMA MR450W
FDA 510(k)
FDA Class 2
·Radiology
EVER-MORE POWDER-FREE LATEX EXAMINATION GLOVES, BLUE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
OsteoMed
FDA UDI
OSTEOMED LLC·00845694075725·FPS 3.5 x 22mm Locking Screw Sterile Qty 2
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 4, 2014
HT50-H1 VENTILATOR
FDA Adverse Event
Injury
·FLIGHT MEDICAL·Product code CBK·July 10, 2013
SMARTPHONE ANDROID APP: PUMP CONNECT
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code PKU·August 1, 2025
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