94 results · 32ms · Sources: EU EUDAMED, US FDA

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MectaLock Extension

FDA 510(k)
FDA Class 2 ·Orthopedic

Poly Stim II

FDA UDI
COMPASS HEALTH BRANDS CORP.·10850958007395·2"x2" Cloth, Case of 10

Medical Science Private Label

FDA UDI
COMPASS HEALTH BRANDS CORP.·00092237900444·2"x2" Cloth,

Poly Stim II

FDA UDI
COMPASS HEALTH BRANDS CORP.·00850958007398·2"x2" Cloth

3I CALCIUM SODIUM PHOSPHATE BONE CEMENT

FDA 510(k)
FDA Class 2 ·Dental

PK ZIP WING CUTTING DISSECTOR

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

BD LOGIC BLOOD GLUCOSE MONITOR

FDA Adverse Event
Malfunction ·NOVA BIOMEDICAL CORPORATION·Product code NBW·October 17, 2008

ENRHYTHM DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011

RESTORE ULTRA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 2, 2013

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

Transpac¿ IV Monitoring Kit, 60", 03 ml Squeeze Flush Device, 2 3 Way Stopcocks and Macrodrip, Item No. 46112-10 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

FDA Enforcement
Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

SET SCREW, TI GAMMA3® Ø8X17.5MM

FDA Adverse Event
Malfunction ·STRYKER TRAUMA KIEL·Product code HSB·July 22, 2014

BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code GIM·December 9, 2024

BD MINIDRAW¿ FINGER SLEEVE, LARGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code GIM·December 9, 2024

BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code GIM·November 27, 2024

BD MINIDRAW¿ FINGER SLEEVE, SMALL

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code GIM·November 27, 2024

BD MINIDRAW¿ FINGER SLEEVE, LARGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code GIM·November 27, 2024

BD MINIDRAW¿ FINGER SLEEVE, SMALL

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code GIM·November 27, 2024

BD MINIDRAW¿ FINGER SLEEVE, LARGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code GIM·April 9, 2025