18 results · 21ms · Sources: EU EUDAMED, US FDA

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Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors

FDA 510(k)
FDA Class 2 ·Orthopedic

ORTHOCORD

FDA UDI
Medos International Sàrl·10886705008841·ORTHOCORD One Violet and One Blue Braided Compo...

iTero Lumina – PC cfg

FDA UDI
Align Technology, Inc.·00816063023296·RMA Scanning Unit, Performance PC configuration...

Vu a-POD™

FDA UDI
Seaspine Orthopedics Corporation·10889981038298·31x24mm Trial 14mm 15 deg. The Vu a-POD interve...

ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

LUMEND FRONTRUNNER CTO CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 8, 2016

BREATHTEK (UBT)

FDA Adverse Event
Product code MSQ·May 31, 2011

EPIC PLUS DR

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008

SLS II

FDA Adverse Event
Malfunction ·SPECTRONECTICS·Product code MFA·August 17, 2011

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 12, 2013

SUTURE UNKNOWN

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAO·July 2, 2025

ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles, Catalog Number: 223114. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.

FDA Recall
Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code NEW·March 22, 2013

ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles, Catalog Number: 223114. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.

FDA Enforcement
Class II ·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·May 1, 2013

bvi Beaver Xstar Safety Slit Knife: (a) REF 378214, 1.4mm, 45o Bevel Up (b) REF 378215, 1.50mm, 45o Bevel Up (c) REF 378217, 1.7mm, 45o Bevel Up (d) REF 378218, 1.8mm, 45o Bevel Up (e) REF 378220, 2.0mm, 45o Bevel Up (f) REF 378222, 2.2mm, 45o Bevel Up (g) REF 378223, 2.3mm, 45o Bevel Up (h) REF 378224, 2.4mm, 45o Bevel Up (i) REF 378227, 2.75mm, 45o Bevel Up (j) REF 378228, 2.8mm, 45o Bevel Up (k) REF 378230, 3.0mm, 45o Bevel Up (l) REF 378232, 3.2mm, 45o Bevel Up (m) REF 378822, 2.2mm, 45o Double Bevel (n) REF 378824, 2.4mm, 45o Double Bevel (o) REF 378825, 2.5mm, 45o Double Bevel (p) REF 378826, 2.65mm, 45o Double Bevel (q) REF 378827, 2.75mm, 45o Double Bevel (r) REF 378828, 2.8mm, 45o Double Bevel (s) REF 378829, 2.85mm, 45o Double Bevel (t) REF 378830, 3.0mm, 45o Double Bevel (u) REF 378832, 3.2mm, 45o Double Bevel (v) REF 370145, 2.5mm, 45o Bevel Up (w) REF 370146, 2.6mm, 45o Bevel Up (x) REF 373025, kojo, 2.5mm, 45o Bevel Up (y) REF 373032, kojo, 3.2mm, 45o Bevel Up Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

FDA Enforcement
Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

FDA Enforcement
Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

FDA Enforcement
Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025