22 results
·
27ms
·
Sources: EU EUDAMED, US FDA
TECHNICON RA-2000(TM) SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RP Standard Healing Abutment, 8.0mm Cuff, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549107771·Healing Abutments are intended for placement on...
Stainless Steel Connector
FDA UDI
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)·10381780033349·Connectors are implantable accessories intended...
MARA Ext.Lower Stop Ctr(10Pk)
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199014100·
Surgimedics®
FDA UDI
COASTAL LIFE TECHNOLOGIES, INC.·00814716020135·Smoke Evacuation Filter
Bioseal Inc.
FDA UDI
BIOSEAL·00630094190143·Red Rubber Tourniquet 18Fr
Medtronic Reusable Instruments
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490499781·INSTRUMENT 901-410 10MM STARTER DISTRCTR
Rampart One Lumbar Interbody Fusion System
FDA UDI
SPINEOLOGY INC.·M7404901410·Rampart One Standard Spacer, 14mm, L, 16°
Vu a-POD Prime NanoMetalene
FDA UDI
Seaspine Orthopedics Corporation·10889981126667·Prime NM Implant, 39x30mm x 14mm, 10 Deg
TCP
FDA UDI
WRIGHT MEDICAL TECHNOLOGY, INC.·00840420118301·
PHORESOR MODEL PM2000
FDA 510(k)
FDA Class 2
·Physical Medicine
DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,
FDA 510(k)
FDA Class 2
·Physical Medicine
UNKNOWN
FDA Adverse Event
WILLIAM COOK EUROPE·Product code DTK·October 27, 2015
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 46
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 2, 2020
OT VERIO PRO PLUS METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014
HIRES 90K
FDA Adverse Event
Injury
·ADVANCED BIONICS LLC·Product code MCM·November 2, 2010
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 2, 2013
ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·June 17, 2020
Affixus¿ Hip Fracture Nail 130¿ 11 mm x 180 mm, Item Number: 814511180
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 19, 2018
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012