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

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WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System

FDA 510(k)
FDA Class 2 ·Orthopedic

XIOS+

FDA UDI
SIRONA DENTAL, INC.·D76462017551·SIRONA XIOS PLUS SENSOR SIZE 1 SHIP KIT

HHM

FDA UDI
Oticon A/S·05707131351579·G500 SC, BTE PP 13 2.4G 105 C048 TAR HHM

METAPHYSARY BROACH ESOP LEFT SIZE 7,5

FDA UDI
FOURNITURES HOSPITALIERES INDUSTRIE·03661489017551·

7450 RV2 MASK

FDA UDI
HANS RUDOLPH, INC.·00817136022536·7450XS FACE MASK-HDGR& 2600 MA

Zodiac

FDA UDI
ALPHATEC SPINE, INC.·00844856063327·TI ILIAC BONE SCREW ASSY, 8.5MM X 55MM X 15°

Zodiac

FDA UDI
ALPHATEC SPINE, INC.·00844856063334·Ti ILIAC BONE SCREW ASSY, 8.5mm X 55mm X 30°

MPW HEMODIALYSIS WATER PURIFICATION SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

APEX MEDICAL DIGITAL TENS TS1211, TS1212

FDA 510(k)
FDA Class 2 ·Neurology

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code MDS·March 24, 2011

GE OEC 9600

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 21, 2008

EON MINI

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 26, 2013

INTERSTIM II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·August 5, 2011

BD¿ BLUNT FILTER NEEDLE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code GAA·October 31, 2018

PERITX DRAINAGE BAG

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·April 3, 2026

Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

FDA Enforcement
Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

PERITX PERITONEAL CATHETER & STARTER KIT

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·October 6, 2025

PERITX PERITONEAL CATHETER & STARTER KIT

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·October 6, 2025

PERITX PERITONEAL CATHETER & STARTER KIT

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·October 6, 2025

PERITX PERITONEAL CATHETER & STARTER KIT

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·October 6, 2025