12 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
LAMINOPLASTY PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN·Product code BTR·February 26, 2014
C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570
FDA 510(k)
FDA Class 2
·Physical Medicine
BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)
FDA 510(k)
FDA Class 2
·Neurology
VKMO 78000 3 QUADROX-I HMO 70000+VHK7000
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 25, 2015
VKMO 78000 #QUADROX-I HMO 70000+VHK7000
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 25, 2015
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 14, 2023
HLM TUBING SET W/SOFTLINE COATING
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DWF·April 6, 2016
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 2, 2013
22 FR, 30 DEGREE CUTTING LOOP ELECTRODE, .014
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code HIH·September 15, 2014
HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 16, 2011
Aurora Series, Aurora 7 lighthead; Models: LED7 (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