16 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Medline Foot Plates and Screws
FDA 510(k)
FDA Class 2
·Orthopedic
SSW CARBIDE TRIMMING AND FINISHING
FDA UDI
Ss White Burs, Inc.·D6901512352·18 BLADE FINISHING CARBIDE 118L - 5 PACK
BALLARD™
FDA UDI
SUNMED, LLC·10889483623299·BALLARD™ CLOSED SUCTION SYSTEM FOR ADULTS, T-Pi...
ProLift
FDA UDI
Life Spine, Inc.·00190837117405·
Pro Lift Instruments
FDA UDI
Life Spine, Inc.·00190837031183·
Ballard* Closed Suction System for Adults
FDA UDI
Avanos Medical, Inc.·00609038987811·BALLARD* Closed Suction Catheter, T-Piece
SETx Precontoured Rod Ø5.5 mm x235 mm Package
FDA UDI
XENCO MEDICAL LLC·B064XM21512351·
Ø5.5mm X 235mm PRECONTOURED ROD
FDA UDI
XENCO MEDICAL LLC·B064XMPH21512351·
ON TRAK TESTCARD
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
GMK EFFICIENCY SPHERE TIBIAL OFFSET HANDLE
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL, SA·Product code LXH·July 30, 2015
OSCILL-SAW-ATTACHM F/532.001 532.010 532
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·October 8, 2014
GLUCOSE MONITORING SYS/KIT
FDA Adverse Event
LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013
NEXGEN COMPLETE KNEE SOLUTION SPIKE ARM
FDA Adverse Event
Malfunction
·ZIMMER INC·Product code LXH·June 21, 2011
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018