20 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BISBLOCK
FDA 510(k)
FDA Class 2
·Dental
MiniKut
FDA UDI
DENTAL ENGINEERING LABORATORIES, LLC·00850001745291·MiniKut Rotary NiTi Endodontic Files .35/.03, 2...
4.2 Dual-Port Mixing Tips (50-pack)
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172000697·Dental material mixing nozzle, non-sterile
4.2 Dual-Port Mixing Tips 50-Pack
FDA UDI
DEN-MAT HOLDINGS, LLC·00359883002626·Dental material mixing nozzle, non-sterile
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033521·Baltic Denture System BDLoad BDLoad ↓ Mw7 PLSEu...
SMALL BONE BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919876281·KM33-521
Brasseler USA
FDA UDI
Provision·00810041065001·
Brasseler USA
FDA UDI
Provision·B504OMKM335210·
Brasseler USA
FDA UDI
Peter Brasseler Holdings, LLC·00887919935438·4.2 DUALPORT MIXTIP YELLOW 50PK
NA
FDA UDI
STERILMED, INC.·10888551007610·SAW BLADE OSCILLATING/SAGITTAL SMALL BONE
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 4, 2019
NA
FDA UDI
STRYKER CORPORATION·04546540466709·Precision Offset (9.0 x 0.51 x 25.0mm)
DISPO-MED 7.6 LITER SHARPS CONTAINER
FDA 510(k)
FDA Class 2
·General Hospital
GEMINI IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ASCENDRA INTRODUCER SHEAT SET
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·April 3, 2013
EON RECHARGEABLE IPG
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·March 24, 2011
H-TRONPLUS PISTON ROD
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·April 23, 2008
Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·April 29, 2020
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024