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