21 results · 38ms · Sources: EU EUDAMED, US FDA

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RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC

FDA 510(k)
FDA Class 2 ·Anesthesiology

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690198895·AK3 Congruent Insert Trial Size 1, 11mm

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450217849·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450226230·

Gorilla Plating System

FDA UDI
Paragon 28, Inc.·00889795017772·Gorilla, Plate, Med Col Rescue, 2.0mm Thk, 11-H...

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07310K0191110·Dilator, Small

PANORET, MODEL 1000A

FDA 510(k)
FDA Class 2 ·Ophthalmic

MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES)

FDA 510(k)
FDA Class 2 ·Radiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 17, 2025

INRATIO

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·September 27, 2010

PASSPORT 2 MONITOR

FDA Adverse Event
Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 16, 2014

AORTIC AP360

FDA Adverse Event
Death ·MEDTRONIC ATS, INC.·Product code LWQ·May 6, 2011

BD RAPID DETECTION OF SARS-COV-2 VERITOR

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·October 1, 2021

PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code KRO·October 15, 2025

BD RAPID DETECTION OF SARS-COV-2 VERITOR¿

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·November 19, 2021

PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code KRO·April 23, 2026

LGN PRSFT STEM 10MMX220MM STRT

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code JWH·October 19, 2017

LEGION HK HINGE KNEE SYSTEM

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code KRO·March 15, 2025

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