22 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Tasso+ Convenience Kit
FDA UDI
Tasso Inc.·00860006434557·Tasso+ convenience kit allows self-collection o...
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221037657·Unitek(TM) Bicuspid Band General Purpose Narrow...
N/A
FDA UDI
TETRA MEDICAL SUPPLY CORP.·00614138124806·GAIT BELT W/BUCKLE 2 X 72
Cadet Cervical Cage
FDA UDI
VALORUS SPINE LLC·00811771033353·Cadet Cervical Cage, 14mm x 16mm x 04mm, Non-Lo...
Cadet Cervical Cage
FDA UDI
VALORUS SPINE LLC·00811771033988·Cadet Cervical Cage, 14mm x 16mm x 04mm, 7° Lor...
VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V
FDA 510(k)
FDA Class 2
·Cardiovascular
MACRO-MICRO DEPTH ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
Cavetto
FDA UDI
NEUROSTRUCTURES, INC·00841508105176·Cervical Cage Trials 14x16x04
Cavetto
FDA UDI
NEUROSTRUCTURES, INC·00841508105473·Trial With Handle Peak to Peak 14x16x04
Cavetto
FDA UDI
NEUROSTRUCTURES, INC·00841508105336·Trial With Handle 14x16x04
UniTip Catheter
FDA UDI
Unisensor AG·07640172971406·
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 3, 2008
X8000 LIGHTSOURCE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·May 31, 2011
POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025
POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025
POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025
POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025
PKG, 3MM INSERT, STRAIGHT NEEDLEHOLDER, 29CM, P/N 0250282061 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014