17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
Nogama
FDA UDI
SILMET LTD·07290012207051·Dental Amalgam Capsules
JOBST Anti-Em
FDA UDI
BSN MEDICAL, INC.·00035664114732·ANTI-EMB STOCKINGS KNEE HIGH CLOSED TOE MEDIUM-...
MAXCUT CARBIDE BUR (10/pk) FGSS 557
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811114731·MAXCUT CARBIDE BUR (10/pk) Shape: Cross Cut Str...
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089476350·
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213033764·Coupling Treatment Tube for 5F Flexibles (13)
SNAZZY2
FDA 510(k)
FDA Class 2
·Physical Medicine
NANOTACK SUTURE ANCHOR 1.4MM
FDA 510(k)
FDA Class 2
·Orthopedic
PRONTO SPOT CHECK PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·July 9, 2018
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 30, 2018
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 30, 2018
ECHELON FLEX 60
FDA Adverse Event
Malfunction
·ETHICON ENGO-SURGERY, LLC·Product code GDW·May 8, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
ASR UNI FEMORAL IMPL SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 13, 2011
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·November 12, 2020
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 5, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025