25 results · 23ms · Sources: EU EUDAMED, US FDA

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STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234

FDA 510(k)
FDA Class 2 ·General Hospital

ODYSSEY®

FDA UDI
Microport Orthopedics Inc.·M684K00616491·

TruForm

FDA UDI
Rmo, Inc.·00885797099693·MAN MLR BDS ASST 100 SE ASIA

AP 24® Smile Pop Toothbrush

FDA UDI
NSE PRODUCTS, INC.·00850021097578·

artVeneer life

FDA UDI
Merz Dental GmbH·D7092001649·artVeneer life lower anteriors, UCS, BL4

Thuvera

FDA UDI
IPG Medical Corporation·00810071230097·Thuvera, Flat Tip, Reusable Laser Fiber, 365um

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500

FDA 510(k)
FDA Class 2 ·Hematology

GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMS OR LESS)

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

HEARTSTART

FDA Adverse Event
Malfunction ·PHILIPS NORTH AMERICA LLC·Product code NSA·July 11, 2025

LOCKING SCREWDRIVER BODY

FDA Adverse Event
Malfunction ·DEPUY FRANCE SAS - 3003895575·Product code HXX·November 8, 2019

SYSTEM, PERITONEAL AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·March 13, 2013

WEB-BASED DATA MANAGEMENT

FDA Adverse Event
Injury ·MEDTORNIC MINIMED·Product code MDS·February 18, 2011

MODULAR MICROPLASTY CUP INSERTER 1/4"-28 THREAD INSERT

FDA Adverse Event
Malfunction ·BIOMET, INC.·Product code LXH·February 18, 2008

ATELLICA NEPH 630 SYSTEM

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code JZW·May 26, 2022

LOCKING SCREWDRIVER BODY

FDA Adverse Event
Malfunction ·DEPUY FRANCE SAS - 3003895575·Product code HXX·March 20, 2018

LOCKING SCREWDRIVER BODY

FDA Adverse Event
Malfunction ·DEPUY FRANCE SAS - 3003895575·Product code HXX·February 2, 2018

ATELLICA NEPH 630 SYSTEM

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code JZW·December 10, 2021

ATELLICA NEPH 630 SYSTEM

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code JZW·February 21, 2022

LOCKING SCREWDRIVER BODY

FDA Adverse Event
Malfunction ·DEPUY FRANCE SAS - 3003895575·Product code HXX·October 23, 2019

Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.

FDA Enforcement
Class II ·Terminated·Sunrise Medical (US) LLC·December 11, 2013