21 results
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27ms
·
Sources: EU EUDAMED, US FDA
CENTRALITE(R)-DLL SERIES
FDA 510(k)
FDA Class 1
·Radiology
BASE
FDA UDI
Nuvasive, Inc.·00887517700322·BASE Guide, Single L
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526791121·MEDI CAT WALKER SHORT BOOT, SMALL
Medegen Medical Products, LLC
FDA UDI
MEDEGEN MEDICAL PRODUCTS, LLC·00673844002785·Bag: Ac 19X23 2.0Ml Org Pr IND 200/CS
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690124764·Modular Stem 11mm x 125mm
Prophy Brush
FDA UDI
DiaDent Group International·08806383525763·A non-sterile rotary dental instrument with nat...
Sierra
FDA UDI
Seaspine Orthopedics Corporation·10889981094256·Drill Guide
PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HS AMICA DEVICES FAMILY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Formula
FDA UDI
STRYKER CORPORATION·07613327054811·[Standard 12-Flute Round Bur, Arthroscopic Shav...
Sustainable Technologies
FDA UDI
Provision·00810041636065·Round bur; 12 flutes (blue; blue)
N/A
FDA UDI
STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825014681·Round Bur 12-Flute (Blue)
NA
FDA UDI
STERILMED, INC.·10888551030366·SHAVER BUR ROUND 12 FLUTE FORMULA SERIES BLUE
ZELTIQ COOLCORE (6.3)
FDA Adverse Event
Injury
·ZELTIQ AESTHETICS INC.·Product code OOK·February 6, 2013
NEXGEN CRUCIATE RETAINING FEMORAL COMPONENT
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code JWH·December 7, 2010
SUMMIT DUOFIX TAP SZ1 STD OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.1818910·Product code LPH·July 22, 2014
1820334-2020-01805
FDA Adverse Event
Malfunction
·COOK INC·Product code FOZ·October 5, 2020
Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·March 13, 2019
Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy, Model 077 Petite 4"x 17",Model 095: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 095 Large 14" x 27 Model 096: Thermophore Classic, Professional Quality Deep-Heat therapy Model 096, Medium, 14" x 14" Model 097: Thermophore Classic, Professional quality Deep-Heat Therapy, Model 097 , Petite, 4" x 17", Model 255: Thermophore Classic Plus, Professional Quality Deep-Heat Therapy, Model 255 Large,14" x 27", Model 256: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 256, Medium, 14" X 14 Model 277: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 277, Petite , 4" x 17" Used for the temporary relief of joint and muscle pain.
FDA Enforcement
Class II
·Terminated·Battle Creek Equipment Co.·November 9, 2016
IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·August 20, 2014