43 results · 22ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

PUMA MODEL VERSION 1.0

FDA 510(k)
FDA Class 2 ·Radiology

Bur PM2-70 80K FC Ø4.5 St

FDA UDI
Bien-Air Surgery SA·17630055517040·

Stainless Steel Femoral Nailing System

FDA UDI
ORTHOFIX SRL·18032568031980·DRILL BIT DIAMETER 4.0 MM LENGTH 310 MM

NA

FDA UDI
Biedermann Motech GmbH & Co. KG·04250869655811·MOSS VRS in:situ Head Placer

NA

FDA UDI
Biedermann Motech GmbH & Co. KG·04250869604956·MOSS 100 Head Inserter

Life Instruments

FDA UDI
Life Instrument Corporation·M930810080110·Spinal Curette 8" #2 angled

Life Instruments

FDA UDI
Life Instrument Corporation·M930810080100·Spinal Curette 8" #1

Surgical tools for erythrocyte & marrow preparation kit

FDA UDI
Arteriocyte Medical Systems, Inc.·M89640K1000010·Sterile Disposable Kit containing single-patien...

PC COATED FLUOROPLASTIC VENT TUBES

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

T2 FEMORAL NAIL

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 29, 2025

Widex

FDA UDI
Widex A/S·05706069720327·Widex D-FA P (Warm beige S-110 ) Telecoil, Volu...

REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRA

FDA Adverse Event
Malfunction ·STRYKER SPINE BORDEAUX·Product code KWP·May 23, 2012

BERKETTE BEACH CHAIR LIMB POSITIONER; (100801); STERILE

FDA Adverse Event
Malfunction ·ASPEN SURGICAL PRODUCTS, CALEDONIA·Product code CCX·January 18, 2021

BERKETTE BEACH CHAIR LIMB POSITIONER; (100801); STERILE

FDA Adverse Event
Malfunction ·ASPEN SURGICAL PRODUCTS, CALEDONIA·Product code CCX·February 23, 2021

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 8, 2013

LIGAMAX CLIP APPLIER

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·September 19, 2014

8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

FDA Adverse Event
Injury ·ST. JUDE MEDICAL·Product code MGB·May 19, 2011

PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM

FDA Adverse Event
Injury ·KINETIC CONCEPTS, INC.·Product code OMP·July 19, 2019

'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805

FDA Recall
Open, Classified ·New Standard Device Inc·Product code KTT·July 23, 2019