37 results
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23ms
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Sources: EU EUDAMED, US FDA
ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
FDA 510(k)
FDA Class 2
·Microbiology
Ecosite Elements
FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2208011·Ecosite Elements is a light-curing, esthetic, r...
ELMED INCORPORATED
FDA UDI
ELMED INCORPORATED·00842180121133·8 MM DIA., 30 CM, ELMED LAPAROSCOPE, 300 VIEWIN...
Life Instruments
FDA UDI
Life Instrument Corporation·M930822080100·Key Periosteal Elevator 8" x 1"
YomiLink Arch (LLUR)
FDA UDI
NEOCIS INC·00810004900523·YomiLink Arch (LLUR)
n/a
FDA UDI
Ortho Development Corporation·00822409067954·Stem ExtensionTrial Diameter 22x80mm
n/a
FDA UDI
Ortho Development Corporation·00822409070695·Snap-on Fem Augment Trial 8mm Posterior Size 2
CHISON DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
QUICKVUE ONE-STEP HCG-COMBO
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TPRLC 133 T1 PPS HO 16X152MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·November 26, 2025
DR FOG TREATED SPONGE, STERILE
FDA Adverse Event
Malfunction
·ASPEN SURGICAL PRODUCTS, CALEDONIA·Product code OCT·October 19, 2020
ONE TOUCH PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 30, 2008
OT ULTRALINK METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·August 23, 2011
M2A-MAGNUM MODULAR HEAD SIZE 52MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 11, 2013
7" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B9900-629, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·April 18, 2018
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019