21 results
·
26ms
·
Sources: EU EUDAMED, US FDA
SPECIMEN COLLECTION PAN
FDA 510(k)
FDA Class 1
·Pathology
THD Procto Software System
FDA UDI
THD SPA·68051887043325·THD DIGITAL MOBILE ADVANCED is an integrated mo...
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209100941·KIT, NAR-4 AID w' CHITOGAUZE - BLK; This kit co...
ACUMED
FDA UDI
Acumed LLC·10806378041075·Univ Tray Clavicle Plate Insert Lid
Falcon
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730088529·Lingual Arch Forming Pliers
HUMERAL NAIL
FDA UDI
Biomet Orthopedics, LLC·00887868031649·
iNSitu™ Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127028762·Blade Femoral Broach Size 9
HUMERAL NAIL
FDA UDI
Biomet Orthopedics, LLC·00887868031656·
HUMERAL NAIL
FDA UDI
Biomet Orthopedics, LLC·00887868031632·
HUMERAL NAIL
FDA UDI
Biomet Orthopedics, LLC·00887868031618·
HUMERAL NAIL
FDA UDI
Biomet Orthopedics, LLC·00887868031601·
HUMERAL NAIL
FDA UDI
Biomet Orthopedics, LLC·00887868031625·
NA
FDA UDI
STRYKER CORPORATION·07613252026693·Straight Micro Diameter Tip, Universal
LITHIUM DILUENT (1500 MM/E)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BLASTOCYST FREEZE MEDIUM, BLASTOCYST THAW MEDIUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·May 2, 2014
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·October 9, 2012
CELL-DYN SAPPHIRE VENT HEAD ASSEMBLY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·August 16, 2010
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018