19 results · 30ms · Sources: EU EUDAMED, US FDA

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Disposable Endoscope Valves Set A

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100219·LIEBERMAN ASPIRATING SPECULUM K-WIRE

STILLE Osteotomes

FDA UDI
Stille AB·07332339211509·OSTEOTOME CINELLI STILLE double-guarded 14 mm 1...

MaxFuse,VBR, 12 (D) x 14 (W) x 13 (H)

FDA UDI
Pioneer Surgical Technology, Inc.·00846468055882·VBR, 12 (D) x 14 (W) x 13 (H)

TOTAL BILE ACIDS ASSAY, MODEL DZ042A

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS

FDA 510(k)
FDA Class 2 ·Dental

PASSEO-18 5/200/90

FDA Adverse Event
Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021

PASSEO-18 6/200/90

FDA Adverse Event
Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 26, 2024

PASSEO-18 2.5/170/130

FDA Adverse Event
Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·January 20, 2021

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 8, 2014

FINELINE II

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVN·July 6, 2011

CAPSUREFIX NOVUS

FDA Adverse Event
Malfunction ·MPRI·Product code DTB·June 7, 2013

D902 LILLIPUT ECMO M PHISIO

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·April 7, 2022

LILLIPUP PMP, LILLIPUT PMP INTEGRATED

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·June 27, 2022

Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·March 20, 2013

Precise Treatment Table. To be used as part of radiation therapy treatment process.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·April 17, 2013

All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·March 12, 2014

IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

FDA Enforcement
Class II ·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019