18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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