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

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BODYHEAT

FDA 510(k)
FDA Class 2 ·Cardiovascular

Bioseal Inc.

FDA UDI
BIOSEAL·00630094190266·Latex Dental Rubber Bands

NA

FDA UDI
Zimmer, Inc.·00889024365339·

NA

FDA UDI
Zimmer, Inc.·00889024365346·

VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726

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

HEARTWAY POWER MOBILITY SCOOTER, S12

FDA 510(k)
FDA Class 2 ·Physical Medicine

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·June 30, 2014

RIATA ACTIVE FIXATION

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013

ACCU-CHEK ® COMPACT TEST DRUM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·November 18, 2010

MAK OSS RS SEGMENTAL ELLIPTICAL FEMORAL COMPONENT 7CM RIGHT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KRO·May 28, 2025

ORTHOPEDIC SALVAGE SYSTEM IM STEM WITH SCREW 11MM X 150MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDI·May 28, 2025

BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

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