29 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CAREGUIDE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
COMPREHENSIVE SHOULDER SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304462557·
Comprehensive® Shoulder System
FDA UDI
Biomet Orthopedics, LLC·00887868268007·
n/a
FDA UDI
HANS RUDOLPH, INC.·00874750007257·2730 2W NRBV W/CUSTOM EXH & MP
Stablecut®
FDA UDI
SYNVASIVE TECHNOLOGY, INC.·00846795002511·
CapSure® Spine System
FDA UDI
Spine Wave, Inc.·10840642105049·PS2 Screw 6.5mm x 55mm
Stablecut®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024494091·
PLANMED SOPHIE & PLANMED SOPHIE CLASSIC
FDA 510(k)
FDA Class 2
·Radiology
THERMO SCIENTIFIC MAS R DOA TOTAL
FDA 510(k)
FDA Class 1
·Clinical Toxicology
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 18, 2019
VERTEX® RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·August 16, 2017
VERTEX® RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·March 3, 2017
ACROM XL 44-41 STD HMRL BRNG
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PAO·February 17, 2017
COMP RVRS SHLDR GLNSP STD 41MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PAO·February 17, 2017
COMP RVS HMRL TI TRAY 44MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PAO·February 17, 2017
VERSA-DIAL/COMP TI STD TAPER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MBF·February 17, 2017
COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PAO·February 17, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·October 18, 2018
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 15, 2013
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·September 17, 2014