15 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405
FDA 510(k)
FDA Class 2
·Physical Medicine
Mini Master Series Bracket
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746070945·1 PAT SETUP MINI MS ROTH 018 U/L 6X6 IFIT W/HK ...
CENTURA PHOTOTHERAPY SPOTLIGHT
FDA 510(k)
FDA Class 2
·General Hospital
BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES
FDA 510(k)
FDA Class 2
·Anesthesiology
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·April 29, 2015
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·August 13, 2014
TRUE BALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·February 21, 2014
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·September 16, 2014
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·October 31, 2014
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·October 31, 2014
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·January 22, 2015
HEARTSTART XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 31, 2013
APEX MONORAIL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORP.·Product code LOX·May 9, 2008
TURBOHAWK¿ PLAQUE EXCISION SYSTEM
FDA Adverse Event
Injury
·EV3 INC.·Product code MCW·April 6, 2011
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024