27 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft
FDA 510(k)
FDA Class 2
·Orthopedic
Anatomic PEEK™ Cervical Fusion System with Nanotechnology
FDA UDI
NANOVIS SPINE, LLC·00814216027993·ANATOMIC PEEK w/ Nano 16 x 14 x 10 x 10°
STEVENS TENOTOMY SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896054370·STEVENS TENOTOMY SCISSORS CURVED LONG BLUNT BLA...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694005913·1.3mm Pilot Drill, Dental Latch
BROLI ADSON FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896059450·BROLI-ADSON FORCEPS STRAIGHT TIPS
Insurgical, Inc.
FDA UDI
Insurgical, Inc.·00860007230004·Drill-Reamer Packaged Assembly
SkinStylus SteriLock MicroSystem
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
uMR 570
FDA 510(k)
FDA Class 2
·Radiology
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·October 15, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 10, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 1, 2013
XLPE 10DEG POLY LINER 64 X 40
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·May 6, 2024
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·April 14, 2015
Stryker Navigation System Dell Model D800 laptop computers (only), Stryker # 7700-309-010 and 6000-200-064.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code HAW·September 8, 2006
REVITAN DIST. CURVED 18/200
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·November 20, 2018
MODULAR NECK X1 12/14 NECK TAPER USE WITH +0 HEADS ONLY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·May 22, 2020
REVISION FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·March 1, 2024
MAZOR X SYSTEM
FDA Adverse Event
Malfunction
·MAZOR ROBOTICS LTD·Product code OLO·January 1, 2026
CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK AAD (2.0 TO 4.0 MM OUTER DIAMETER VESSELS), M
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only*** This device is intended to be used with Anspach Systems
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·July 2, 2014