22 results · 21ms · Sources: EU EUDAMED, 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