10 results · 21ms · Sources: EU EUDAMED, US FDA

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Keeler TonoCare Tonometer

FDA 510(k)
FDA Class 2 ·Ophthalmic

Border-Lock® Upper Tray #43

FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172015813·Dental impression tray, single-use

HEARTWAY POWER MOBILITY SCOOTER, S11

FDA 510(k)
FDA Class 2 ·Physical Medicine

BIOMERS TRANSLUCENT ORTHODONTIC WIRE

FDA 510(k)
FDA Class 2 ·Dental

OT ULTRA2 METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE GMBH·Product code NBW·August 14, 2019

BECKMAN COULTER AU480 CLINICAL CHEMISTRY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code JJE·June 21, 2013

NEURO SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.5X5

FDA Adverse Event
Malfunction ·STRYKER OSTEOSYNTHESIS FREIBURG·Product code JEY·July 8, 2011

ACCU-CHEK ADVANTAGE TEST STRIPS

FDA Adverse Event
Injury ·ROCHE DIAGNOSTICS·Product code NBW·September 30, 2008

CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018