17 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Susceptibility Test Discs, Antimicrobial
FDA Pre-Market Approval
FDA Class 2
·MS 2 AUTOMATED SYSTEM
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5821602420·SCISSORS, SURGICAL TISSUE, DENTAL
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306801549·Ferris-Smith Forceps, 2x3, 18cm
Biomet® 360 Instrument
FDA UDI
Biomet Orthopedics, LLC·00887868562976·
BIOMET® 360
FDA UDI
Biomet Orthopedics, LLC·00880304496088·
AROX 45 JBP
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·November 3, 2006
PHILOS DR
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO·Product code DTB·November 3, 2006
PFC SIGMA POSTERIOR LIPPED INSERT
FDA Adverse Event
Injury
·JOHNSON & JOHNSON PROFESSIONAL, INC.·Product code JWH·June 18, 1998
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 12, 2024
LIFEPORT VASCULAR ACCESS SYSTEM
FDA Adverse Event
Injury
·HORIZON MEDICAL PRODUCTS, INC.·Product code LJT·November 16, 2001
AUTO SUTURE ROTICULATOR 55-4.8
FDA Adverse Event
Malfunction
·UNITED STATES SURGICAL CORP·Product code GAG·January 26, 2000
ARROW/KONTRON 9FR INTRA-AORTIC BALLOON
FDA Adverse Event
Injury
·ARROW INTL., INC.·Product code DSP·March 30, 1998
DREAMSTATION AUTO BIPAP
FDA Adverse Event
Injury
·RESPIRONICS, INC·Product code BZD·November 9, 2021
UNKNOWN NCB PLATE
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HRS·June 11, 2024
TELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series TELETOM is designed for use in operating rooms, medical treatment rooms, intensive care units, or any area of a medical facility that requires a ceiling mounted device to supply power, medical gases, and data-communication services. TELETOM is designed to be used in rooms that have been constructed to meet National Fire Protection Association.
FDA Enforcement
Class II
·Terminated·Berchtold Corp.·October 28, 2015
Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, 60010743-407; 3213-36/50022126-001, 60013879-307, 60013879-407, 60013879-707; CD3211-36/100006984,100012548, 100012550, 100016680, 100031621, 100035618, 100035619, 100042487, 100047194; CD3211-36Q/100004091, 100004093,100019784, 100035620, 100042486, 100047054; CD3215-36/100006995, 100010246, 100010247, 100010249, 100010250, 100012569, 100012570, 100034981, 100046577, 100046802, 60019065; CD3215-36Q/100004059, 100004060, 100004061, 100023304, 100030590, 100033678, 100042492, 100046803, 100046906
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012