19 results · 20ms · 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.

HIGH TIBIAL OSTEOTOMY PLATING SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526189799·LEVAMED ACTIVE ANKLE SUP BLACK R IV

Sanibel Supply A/S

FDA UDI
Interacoustics A/S·05711117019100·ETB Titan standard electrode cable kit/3pcs (BR...

EZ2C

FDA UDI
FGX INTERNATIONAL INC.·00193033278369·

EZ2C

FDA UDI
FGX INTERNATIONAL INC.·00193033278314·

EZ2C

FDA UDI
FGX INTERNATIONAL INC.·00193033278321·

EZ2C

FDA UDI
FGX INTERNATIONAL INC.·00193033278345·

EZ2C

FDA UDI
FGX INTERNATIONAL INC.·00193033278352·

EZ2C

FDA UDI
FGX INTERNATIONAL INC.·00193033278338·

RADS

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

UNKNOWN ORTHOSIS

FDA Adverse Event
Injury ·BIOMET SPAIN, S.L.·Product code MNI·January 6, 2017

10NM TORQUE LIMITING HANDLE 6MM HXC

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code LXH·March 19, 2013

ASR UNI FEMORAL IMPL SIZE 49

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 4, 2011

PURITAN BENNETT

FDA Adverse Event
Injury ·PURITAN BENNETT·Product code CBK·March 10, 2008

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025; 3.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN030; 3.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN035; 4.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN040; 2.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP025; 3.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP030; 3.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP035; 4.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP040; 4.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP045; 5.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP050; 5.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP055

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024