21 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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ARTHREX COMPRESSION STAPLE
FDA 510(k)
FDA Class 2
·Orthopedic
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221024657·Unitek(TM) Lingual Sheaths Solid Tube U/L Hook ...
Symmetry Malis®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482140048·Forcep Bipolar Bayonet Angled 90 Deg Titanium 0...
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0101110·Distractor, Smooth Paddle, 11mm
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101110·Distractor, Smooth Paddle, Lordotic, 11mm
General Instrument
FDA UDI
ALPHATEC SPINE, INC.·00840180506714·Longer Rotating Distractor, Holed, 11mm
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 27, 2024
DIAMONDCOAT ULTRASONIC INSERTS
FDA 510(k)
FDA Class 2
·Dental
CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 26, 2013
LPS TIB HINGE INSERT SM 18MM
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code KRO·July 18, 2008
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NTE·May 6, 2011
PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KRO·October 15, 2025
PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KRO·April 23, 2026
LGN PRSFT STEM 10MMX220MM STRT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·October 19, 2017
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022
LEGION HK HINGE KNEE SYSTEM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KRO·March 15, 2025
A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, Surgipro, Teleflex Medical, Boss Instruments, Symmetry Surgical, Phoenix Instruments, GICAL, and CareFusion brand names.
FDA Enforcement
Class II
·Terminated·Instrumed International, Inc.·December 17, 2014
An external vein stripper is an extravascular device used to remove a section of a vein sold under the Symmetry Surgical, CareFusion, Boss Instruments, Phoenix Instruments, Autobahn Surgical, Echo Instruments, Millennium Surgical, B.B.M. Surgical Instruments, Stealth Surgical, Medline Industries, Medsaver M S I Precision, and Surgical Direct brand names.
FDA Enforcement
Class II
·Terminated·Instrumed International, Inc.·December 17, 2014
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.
FDA Enforcement
Class II
·Terminated·Instrumed International, Inc.·October 8, 2014