19 results
·
32ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
AutoStrut
FDA 510(k)
FDA Class 2
·Orthopedic
Edge™ Diamond ND014-6EF Needle
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172002615·Diamond dental bur, reusable
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·00842331121968·Titanium Rhoton Bipolar Forceps, round handles,...
In-Ovation ® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807191241001·IN-OVATION® mini Base Rx 018/UL4-5 -7T 0A 2D
Arthroscopy sheath
FDA UDI
SOPRO-COMEG GmbH·04059082032955·
In-Ovation ® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807191241811·IN-OVATION® mini EURO 018/UL4 -7T 0A HK
In-Ovation ® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807191241101·IN-OVATION® mini Base Rx 018/UL4-5 -7T 0A 2D HK
Trocar
FDA UDI
SOPRO-COMEG GmbH·04059082006253·
Obturator
FDA UDI
SOPRO-COMEG GmbH·04059082032948·
Arthroscopy sheath
FDA UDI
SOPRO-COMEG GmbH·04059082006277·
Obturator
FDA UDI
SOPRO-COMEG GmbH·04059082006260·
Trocar
FDA UDI
SOPRO-COMEG GmbH·04059082032931·
In-Ovation ® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D80719124110R1·IN-OVATION® mini Rhodium Base Rx 018/UL4-5 -7T...
MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER; RAD 87 PULSE CO-OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
REPLENS LONG-LASTING VAGINAL MOISTURIZER (PRE-FILLED APPLICATOR)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·July 19, 2011
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·June 26, 2013
FENESTRATED BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code GEI·September 26, 2008
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018