20 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ELECTRONIC PULSE STIMULATOR
FDA 510(k)
FDA Class 2
·Neurology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517290380·CoRoent XL-XW, 12x24x60mm STD
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00887868558726·
BIOMET KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304231979·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197051088·Bengolea Hemostatic Forceps
curved...
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·December 17, 2021
ADVANTX VASCULAR SYSTEM CABLE
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS EUROPE·Product code IZI·January 5, 2001
TROOPER OXYGEN CONCENTRATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
A/C ENZYMATIC VITAMIN B6 ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVANTX LC, LC+, LCA, LCV+ CABLES
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS EUROPE·Product code IZI·January 5, 2001
Vu aPod™ - L
FDA UDI
Seaspine Orthopedics Corporation·10889981046118·LATERAL IMPLANT, SPINPLATE™ ANGLED, LORDOTIC, 1...
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 12, 2015
VA-LCP VOL-DIST-RADIUSPL2.4 R 5+4HO L65
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HRS·June 3, 2013
S-ROM HEAD FEMORAL COCR 28+12
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code JDI·June 22, 2011
TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code LOX·October 3, 2014
EDI BZO Uncut Sheet - Cup*, Item No. 160170
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
Allura Xper FD20 Biplane; Model Number: 722008;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026
MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 28, 2019
HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070 HAA60-14050 HAA60-14080 HAA60-14090 HAA60-15020 HAA60-15030 HAA60-15040 HAA60-15050 HAA60-15060 HAA60-16030 HAA60-16040 HAA60-16050 HAA60-16070 HAA60-16090 HAA60-17040 HAA60-17060 HAA60-17080 HAA60-18010 HAA60-18030 HAA60-18040 HAA60-18050 HAA60-18060 HAA60-18090 HAA60-20030 HAA60-20040 HAA60-20050 HAA60-20060 HAA60-20080 HAA60-20090 HAA60-22050 HAA60-22060 HAA60-25030 HAA60-25040 HAA60-25050 HAA60-25060 HAA60-30060 HAB60-09030 HAB60-10030 HAB60-10040 HAB60-11040 HAB60-11050 HAB60-12040 HAB60-12060 HAB60-13040 HAB60-13050 HAB60-13060 HAB60-14050 HAB60-15060 HAB60-16070 HAB60-16090 HAB60-17080 HAB60-18010 HAB60-18090 HAB60-20080 HAB60-20090 808200000 Product Usage: These devices are intended for osteosynthesis, external fixation of fractures or bone lengthening procedures.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019
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