148 results · 27ms · Sources: EU EUDAMED, US FDA

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TruMatch CMF Titanium 3D Printed Implant

FDA 510(k)
FDA Class 2 ·Dental

SMITH & NEPHEW RADIOPAQUE TRIAL NECKS

FDA 510(k)
FDA Class 2 ·Orthopedic

SPERMCHECK VASECTOMY

FDA 510(k)
FDA Class 2 ·Hematology

LUMINOS LOTUS MAX

FDA Adverse Event
Malfunction ·SIEMENS HEALTHINEERS AG·Product code OWB·March 5, 2025

TAXUS (R) LIBERTÉ (R)

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·July 23, 2011

PAINSMART IOD

FDA Adverse Event
Malfunction ·MOOG DEVICE GROUP·Product code FRN·May 30, 2013

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 19, 2008

ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code FGE·December 13, 2024

Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

FDA Recall
Open, Classified ·Philips North America·Product code LNH·April 14, 2026

ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·October 24, 2024

Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

FDA Recall
Open, Classified ·Philips North America·Product code LNH·April 14, 2026

Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

FDA Enforcement
Class II ·Ongoing·Philips North America·May 6, 2026

Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

FDA Recall
Open, Classified ·Philips North America·Product code LNH·April 14, 2026

ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·October 17, 2023

Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

FDA Enforcement
Class II ·Ongoing·Philips North America·May 6, 2026

N-COMPASS NITINOL STONE EXTRACTOR

FDA Adverse Event
Malfunction ·COOK INC·Product code LQR·April 1, 2022

ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code GBO·October 11, 2021

ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·July 1, 2024

ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·July 5, 2024

ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·August 6, 2020