80 results · 24ms · 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.

Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurfac

FDA 510(k)
FDA Class 2 ·Cardiovascular

KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH

FDA 510(k)
FDA Class 2 ·Dental

CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM)

FDA 510(k)
FDA Class 2 ·Cardiovascular

ARSENAL PETITE LAPIDUS PLATE, R

FDA Adverse Event
Injury ·TRILLIANT SURGICAL·Product code HRS·April 3, 2020

CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·February 6, 2015

METS MODULAR DISTAL FEMUR IMPLANT

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 24, 2014

CUSTOM DISTAL FEMUR IMPLANT

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 24, 2014

CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT

FDA Adverse Event
Injury ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·March 20, 2015

CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·March 13, 2015

CUSTOM DISTAL FEMUR IMPLANT

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 23, 2014

CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT

FDA Adverse Event
Injury ·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·May 15, 2015

STABLE BASE

FDA Adverse Event
Injury ·LEONHARD LANG GMBH·Product code DRX·November 17, 2020

CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 19, 2014

CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT

FDA Adverse Event
Injury ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·March 20, 2015

CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT

FDA Adverse Event
Injury ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·April 16, 2015

CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 19, 2014

STABLE BASE

FDA Adverse Event
Injury ·LEONHARD LANG GMBH·Product code DRX·November 25, 2020

SJM BIOCOR SUPRA STENTED VALVE W/ FLEXFIT SYSTEM

FDA Adverse Event
Death ·ST JUDE MEDICAL BRASIL LTDA.·Product code LWR·June 21, 2013

RESTORE RECHARGEABLE NEUROSTIMULATOR

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 19, 2011

MITEK EXPRESSEW III NEEDLE

FDA Adverse Event
Malfunction ·DEPUY MITEK·Product code LXH·October 21, 2014