21 results · 21ms · 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.

Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series

FDA 510(k)
FDA Class 2 ·Cardiovascular

Test Chambers for Irrigation/Aspiration Cannulas

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896107847·Test Chambers for Irrigation/Aspiration Cannulas

N.A.

FDA UDI
DENTAURUM GmbH & Co.KG·J0111631131000·CONTEC lc primer / adhesive / For CONTEC lc bra...

EP-WORKMATE

FDA 510(k)
FDA Class 2 ·Cardiovascular

VASCULAIRE COMPRESSION SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

WAVEWRITER ALPHA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 17, 2022

CORTICAL BONE SCREW, ÿ 4X32MM

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code HSB·November 7, 2025

BLUNT TIP SCREW, ÿ 4X44MM

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code HSB·November 7, 2025

CORTICAL BONE SCREW, ÿ 4X30MM

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code HSB·November 7, 2025

BLUNT TIP SCREW, ÿ 4X48MM

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code HSB·November 7, 2025

SYNCHROMED II

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·December 1, 2015

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Malfunction ·ETHICON·Product code FTL·July 15, 2011

LEAD MODEL 304

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·June 11, 2013

XIA LP POLYAXIAL SCREW 6.5 X 40MM

FDA Adverse Event
Injury ·STRYKER SPINE BORDEAUX·Product code KWP·September 16, 2008

BLUNT TIP SCREW, ÿ 4X46MM

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code HSB·November 7, 2025

PROXIMAL HUMERUS NAIL CAP, 0MM

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code HSB·November 7, 2025

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·February 4, 2016

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 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

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