64 results · 24ms · Sources: EU EUDAMED, US FDA

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ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682

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

Medtronic Reusable Instruments

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978959054·DISTRACTOR 9091310 STR 10MM 4 DEG

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690199007·AK3 Congruent Insert Trial size 3, 10mm

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450406700·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450465356·

NIDO Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07315K0113100·Decorticating Planer

K091319

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·January 9, 2026

NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001; HP-BPM0002; HP-BPM0003; HP-BPM0003-1

FDA 510(k)
FDA Class 2 ·Cardiovascular

VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

REMSTAR AUTO A-FLEX

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·January 12, 2026

ANN BLUNT TIP SCREW 4X36MM

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code HSB·June 6, 2024

REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS, FR

FDA Adverse Event
Injury ·RESPIRONICS, INC·Product code BZD·August 5, 2021

REMSTAR PRO C-FLEX

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·December 31, 2025

REMSTAR

FDA Adverse Event
Injury ·RESPIRONICS, INC.·Product code BZD·October 22, 2024

BIPAP PRO BIFLEX

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·March 5, 2026

REMSTAR

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·October 28, 2024

DREAMSTATION AUTO CPAP

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·April 10, 2025

REMSTAR PRO C-FLEX+

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·January 7, 2026

PASSPORT 2 MONITOR

FDA Adverse Event
Malfunction ·MINDRAY DS USA, INC.·Product code DSI·April 30, 2013

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·September 16, 2014