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

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FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25

FDA 510(k)
FDA Class 2 ·Hematology

AOSCAPTURED CANCELLOUS SCREW, PARTIAL THREAD 6.0mm x 65mm

FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665021011·

N/A

FDA UDI
BIOMET MICROFIXATION, INC·00841036025939·

DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR

FDA 510(k)
FDA Class 1 ·General Hospital

INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO)

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

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 23, 2024

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 13, 2025

CG+ PICC/DELTA KIT: 1-L 4.5 FR X 55 CM

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL INC.·Product code LJS·September 25, 2016

SOLETRA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·April 16, 2013

VERSYS HIP SYSTEM FEMORAL STEM FIBER METAL TAPER COLLARLESS NECK TAPER W/ CALCIC

FDA Adverse Event
Malfunction ·ZIMMER, INC.·Product code KWY·June 13, 2008

COBAS C111

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code CGA·April 18, 2011

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015