27 results · 20ms · Sources: EU EUDAMED, US FDA

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WHILL Model C2

FDA 510(k)
FDA Class 2 ·Physical Medicine

CD-Chex CD34

FDA UDI
STRECK, INC.·30844509000489·A positive procedural control for enumerating C...

XTRAFIX EXTERNAL FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

ESPRIT VENTILATOR

FDA Adverse Event
Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·October 29, 2008

ASR 300 SPIKED CUP SIZE 54

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011

PELVISOFT ACELLULAR COLLAGEN BIOMESH

FDA Adverse Event
Injury ·TISSUE SCIENCE LABORATORIES·Product code FTM·July 3, 2013

SNAPLOC WIRE GUIDE LOCKING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·December 18, 2024

SNAPLOC WIRE GUIDE LOCKING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·December 16, 2024

SNAPLOC WIRE GUIDE LOCKING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·May 20, 2024

SNAPLOC WIRE GUIDE LOCKING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·June 10, 2024

SNAPLOC WIRE GUIDE LOCKING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·December 13, 2024

SNAPLOC WIRE GUIDE LOCKING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·November 11, 2024

SNAPLOC WIRE GUIDE LOCKING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·November 11, 2024

CustMbite, Model Number CBT-SRS-UL

FDA Enforcement
Class II ·Ongoing·Dental Choice Holding Llc·August 10, 2022

NANOZOOMER S360 (THIS IS AN IVDD PRODUCT, NOT SOLD IN THE U.S.)

FDA Adverse Event
Malfunction ·HAMAMATSU PHOTONICS K.K, SYSTEMS DIVISION,·Product code PSY·June 5, 2023

SNAPLOC WIRE GUIDE LOCKING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·November 12, 2024

SNAPLOC WIRE GUIDE LOCKING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·December 16, 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

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