26 results · 22ms · Sources: EU EUDAMED, US FDA

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Safety Insulin Pen Needles

FDA 510(k)
FDA Class 2 ·General Hospital

Cliniview 11

FDA UDI
PaloDEx Group Oy·06430035872350·

CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 23, 2024

ANALYTICAL P MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·October 23, 2008

ASR ACETABULAR CUPS 50

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

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 9, 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

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