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

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STRYKER ESSX WITH NAVIGATION MOUNT

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

NA

FDA UDI
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH·EPTWS0800520·

Valencia Pedicle Screw System

FDA UDI
Altus Spine, LLC·00843210134611·T-25 Drive Shaft, Long

Novo Surgical

FDA UDI
NOVO SURGICAL, INC.·00842331101502·Titanium Jeweler Bipolar Forceps, 0.4 mm tip, 3...

Symmetry Surgical

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482139585·Symmetry® Forceps; Jeweller Bipolar; 30° Tip; T...

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450178577·

Persona® PPS®

FDA UDI
Zimmer, Inc.·00889024631014·

Persona® PPS®

FDA UDI
Zimmer, Inc.·00889024631021·

X-RAY MONOBLOCK, MONOBLOCK XRS-60-330

FDA 510(k)
FDA Class 1 ·Radiology

RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CARDIOSAVE HYBRID, TYPE G PLUG

FDA UDI
Datascope Corp.·10607567108438·CARDIOSAVE HYBRID, TYPE G PLUG

AVISTA MRI

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 17, 2025

XENON LIGHT SOURCE 300 WATT

FDA Adverse Event
Malfunction ·INTEGRA LUXTEC, INC.·Product code FTD·May 29, 2009

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 26, 2013

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·May 6, 2011

POLYFLUX LR CAPILLARY DIALYZER

FDA Adverse Event
Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code MSF·July 24, 2008

ARCOMXL 32MM +3 MROM LNR SZ 22

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code LZO·October 7, 2014

32MM MOD HEAD COCR -6MM NECK

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDI·January 12, 2015

CUS RNGLC II CONST LNR 22X32+5

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code LZO·January 12, 2015

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-0800-65 0998-UC-0800-31* 0998-UC-0800-33* 0998-UC-0800-52* 0998-UC-0800-53* 0998-00-0800-55* *Not US distribution

FDA Recall
Open, Classified ·Datascope Corp.·Product code DSP·June 5, 2023