BEUDAMED
    18 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Non-Sterile Zirconia Block

    FDA 510(k)
    FDA Class 2 ·Dental

    Bernafon

    FDA UDI
    Bernafon AG·05711584090220·ZERENA 7 B 105 FW 3.0

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780433620·Integra® Jarit® Senn Retractor, 6-1/4", Double-...

    SAIPH

    FDA UDI
    MATORTHO LTD·05055455509351·SAIPH Cemented Patella 30mm

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306821912·Buck Ear Curette - #2, Sharp, Angled: 14.5cm

    Ophthalmic Retractor

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101094·HELVESTON "BIG BARBIE" RETRACTOR 9MM

    CONVOLUTED FOAM PAD

    FDA UDI
    MIZUHO ORTHOPEDIC SYSTEMS, INC.·00842430105838·

    LinkBio Instrument

    FDA UDI
    Link Bio Corp·00810022402122·Broach, Tibial Cone, S Full

    SAIPH KNEE

    FDA Adverse Event
    Malfunction ·MATORTHO LIMITED·Product code JWH·April 3, 2019

    SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700

    FDA 510(k)
    FDA Class 2 ·Neurology

    SAIPH KNEE

    FDA Adverse Event
    Malfunction ·MATORTHO·Product code JWH·October 9, 2018

    MAYFIELD MODIFIED SKULL CLAMP

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code HBL·June 24, 2013

    NAVISTAR® THERMOCOOL® ELECTROPHYSIOLOGY CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code OAD·October 21, 2014

    LUMAX 340 HF-T

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code MRM·June 30, 2011

    Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TBil_2 assay is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates using the Atellica¿ CH Analyzer. Measurement of total bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder block, A total bilirubin measurement in newborn infants is intended to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·April 1, 2020

    Walgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # ("W") 311917111728 item # 479241 UPC # ("Well at Walgreens") 311917143354 item # 156744 Used to secure, close and support small cuts and wounds.

    FDA Enforcement
    Class II ·Terminated·ASO, LLC·August 14, 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