28 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED, AGC-GOLDBONDER, AGC GLAVANOGOLD
FDA 510(k)
FDA Class 2
·Dental
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001041·artVeneer life upper anteriors, BOM, A2
Sinton Medical Products
FDA UDI
Shenzhen Boon Medical Supply Co., Ltd.·06938327900847·1-60"(1500mm) Straight Tubing with Dual Check V...
NA
FDA UDI
Berchtold Holding GmbH·07613327170320·Radial setting clamp. Keep Dry.
Sinton Medical Products
FDA UDI
Shenzhen Boon Medical Supply Co., Ltd.·06938327902742·1-60"(1500mm) Straight Tubing with Dual Check V...
Medstone
FDA UDI
Stille AB·07332339232566·TABLE, EXAMINATION, MEDICAL, POWERED
Medical Facets NC
FDA UDI
MEDICAL FACETS NC LLC·M933MDF20010410·2.4mm Cannulated Screw, Self Drilling, Short Th...
TUFF UNICON IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·March 19, 2025
TUFF UNICON IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·March 19, 2025
MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDERED
FDA 510(k)
FDA Class 1
·General Hospital
ELECSYS ANTI-TPO CALCHECK
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MultiPolar®
FDA UDI
Zimmer, Inc.·00889024115248·
MULTIPOLAR BIPOLAR CUP LINER
FDA Adverse Event
Malfunction
·ZIMMER MANUFACTURING B.V.·Product code KWY·December 9, 2016
TUFF UNICON IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·June 23, 2025
MAYFIELD MODIFIED SKULL CLAMP
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code HBL·June 14, 2017
MAYFIELD MODIFIED SKULL CLAMP
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code HBL·November 22, 2017
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·February 26, 2013
TRANSESOPHAGEAL ENDOSCOPIC TRANSDUCER
FDA Adverse Event
Other
·PHILIPS ULTRASOUND·Product code IYN·February 11, 2011
PREMIUM PLUS CEEA 31 INSTR. W/TILT-TOP
FDA Adverse Event
Injury
·PONCE-USS·Product code GAG·February 20, 2008
Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L, CF-Q150I, CF-Q150L, CF-Q160S, CF-Q180AI, CF-Q180AL. 510(k) Numbers: K954451, K112680, K100584, K051645, K111756, K001241, K911278.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023