21 results · 24ms · Sources: EU EUDAMED, 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