23 results
·
21ms
·
Sources: EU EUDAMED, US FDA
CERTAIN BELLATEK PROVISIONAL ABUTMENTS
FDA 510(k)
FDA Class 2
·Dental
ArgenZ HT+ 98x12 ML OM2B
FDA UDI
ARGEN CORPORATION, THE·D818130310·Dental porcelain/ceramic restoration kit
EVONOS GMBH & Co. Kg
FDA UDI
Gyrus ACMI, LLC·00821925012684·SCHEER DELICATE RIGHT ANGLE PICK
NUPRO®
FDA UDI
Dentsply Professional·D0031303101·NUPRO® 5% Sodium Fluoride White Varnish, Patien...
N/A
FDA UDI
Tyber Medical, LLC·M695M1303100·
IdentiTi
FDA UDI
ALPHATEC SPINE, INC.·00190376204604·ALIF Straight Tamp, Single-Prong
microdot®
FDA UDI
Cambridge Sensors USA LLC·00847713000626·Black Nitrile Powder Free Examination Glove (La...
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981176006·Z-Rod, Dia. 6.0mm, Titanium, 310mm
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973101147·Poly Insert PS, Size 3, 10mm
Scorpio
FDA UDI
Howmedica Osteonics Corp.·07613153992424·Posterior Stabilized Tibial Insert
BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNTHES STAINLESS STEEL MODULAR HAND SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CONMED
FDA Adverse Event
Malfunction
·ASPEN LABORATORIES, INC.·Product code GEI·July 1, 1999
BOVINE XENOSURE BIOLOGIC PATCH
FDA Adverse Event
Injury
·LEMAITRE VASCULAR, INC.·Product code DSY·November 30, 2017
BOVINE XENOSURE BIOLOGIC PATCH
FDA Adverse Event
Injury
·LEMAITRE VASCULAR, INC.·Product code DXZ·November 30, 2017
Truliant
FDA UDI
Exactech, Inc.·10885862320698·
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code BTI·May 24, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code CAW·September 30, 2014
RESTORE ULTRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·June 13, 2011
COMP LK SCR 3.5HEX 4.75X25 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·September 19, 2022