17 results · 20ms · Sources: EU EUDAMED, US FDA

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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