22 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MeMed BV
FDA 510(k)
FDA Class 2
·Microbiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777518·LUMBAMED PLUS FLEX PAD M SILVER IV
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777471·LUMBAMED PLUS FLEX PAD WM SILVER V
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777464·LUMBAMED PLUS FLEX PAD WM SILVER IV
KIMTECH PURPLE NITRILE EXAM GLOVES, STERILE SINGLES (M)
FDA UDI
KIMBERLY-CLARK GLOBAL SALES, LLC·10036000521020·Examination Gloves
REGENEREX HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304450141·
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319721940·Lambotte Osteotome 6-3/4" (16.9cm), 8mm wide, s...
Radius Plate PROlock, Wide
FDA UDI
I.T.S. GmbH·09120034303227·Radius Plate PROlock, Wide, 4-Hole, Right
OFFSET ACETABULAR AUGMENT PROVISIONAL
FDA UDI
Biomet Orthopedics, LLC·00880304451124·
THERASAGE HEATING PAD
FDA 510(k)
FDA Class 2
·Physical Medicine
Mydriatic Hyperspectral Retinal Camera (MHRC-C1)
FDA 510(k)
FDA Class 2
·Ophthalmic
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197493758·360° Laminectomy Punch
40° an...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
GOLDEN COMFORTER
FDA Adverse Event
Malfunction
·GOLDEN TECHNOLOGIES, INC.·Product code INO·October 3, 2012
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·October 21, 2008
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 11, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 8, 2013
Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015