16 results
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24ms
·
Sources: EU EUDAMED, US FDA
(DISPOSABLE) VAGINAL SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CAMLOG
FDA UDI
Preat Corporation·00842092125182·CAMLOG® Screw-Line-compatible 5.0mm Blue Light ...
CRITI-KIT DENTAL KIT 200
FDA UDI
HF ACQUISITION CO. LLC·00850065007083·
SCANLAN® Needle Holders
FDA UDI
SCANLAN INTERNATIONAL INC·00846159003451·Jacobson Needle Holder
SCANLAN® Titanium Needle Holder
FDA UDI
SCANLAN INTERNATIONAL INC·00846159033069·Jacobson Needle Holder, Ti JHSNH, RD, STL D-D J...
BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
POLYESTER NONABSORBABLE SURGICAL SUTURES, USP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AVAULTA BIOSYNTHETIC SUPPORT SYSTEM
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTP·June 11, 2009
BECKMAN COULTER HEMOSIL SILICA CLOTTING TIME
FDA Adverse Event
Malfunction
·Product code GFO·February 23, 2011
IAB : 8 FR - 40 CC FOS
FDA Adverse Event
Injury
·ARROW INTERNATIONAL INC·Product code DSP·February 26, 2008
UNKNOWN KNEE TIBIAL TRAY
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·November 27, 2019
UNKNOWN KNEE TIBIAL INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·November 24, 2019
UNKNOWN KNEE FEMORAL
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·November 24, 2019
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025