368 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LED.L, LED.M, LED.G, LED.B
FDA 510(k)
FDA Class 2
·Dental
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756002707·Wrist/Forearm Splint
n/a
FDA UDI
Ortho Development Corporation·00822409075089·Resection Guide 25mm
ConMed
FDA UDI
Provision·B504OM50800250·
Saw Blade
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613214855·ConMed® OSCILLATING SAWBLADE
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014604121·SKYTRON STND - 300/5001/6001/6002/6500/6600/120...
VADER Pedicle System, Rod, Ti, Straight, Ø 6.0 r000 x 250 mm
FDA UDI
icotec AG·07640164847221·VADER Pedicle System, Rod, Ti, Straight, Ø 6.0 ...
ELECTRICATOR MODEL 26000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
A1C-CELLULAR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·February 17, 2019
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·January 24, 2019
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 24, 2013
LIFEPAK 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·April 6, 2011
PROXIMATE ILS CURVED CIR STAPL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GDW·July 17, 2008
2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·November 30, 2016
LOGIC TIBIA PS MOD INSRT SZ 2 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·June 4, 2024
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·January 20, 2016
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·July 26, 2018
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·February 27, 2025
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM