23 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IPS Style Ceram, IPS Style Ceram One, IPS Style Press
FDA 510(k)
FDA Class 2
·Dental
2.0 LACTOSORB SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036054434·
Kirwan
FDA UDI
KIRWAN SURGICAL PRODUCTS LLC·00841019103777·Titanium Bipolar Coagulation Forceps 3 1/2" (8....
Simpact Tri-Fin
FDA UDI
Life Spine, Inc.·00190837062644·Exchange Pin, Stainless Steel
SunMed
FDA UDI
SUNMED, LLC·20889483000745·GUEDEL PVC SZ3 GREEN 80mm P/50
2.0 LACTOSORB SYSTEM CURVED PLATE 6 HOLE
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·December 27, 2019
EXEL SECURE TOUCH II SAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
SKELETAL DYNAMICS STERILIZATION TRAYS
FDA 510(k)
FDA Class 2
·General Hospital
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·February 21, 2018
CARELINK
FDA Adverse Event
Malfunction
·RICE CREEK MANUFACTURING·Product code DXY·June 7, 2013
COLLEAGUE PRE 1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Injury
·TERUMO MEDICAL CORPORATION·Product code DYB·May 4, 2018
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·December 16, 2019
2.0 LACTOSORB SYSTEM STRAIGHT PLATE 4 HOLE
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·December 27, 2019
AMISTEM COLLARED STEM, HA COATED SIZE 6 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 8, 2017
EDI BZO Uncut Sheet - Cup*, Item No. 160170
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
EDI BZO UNCUT SHEET-CARD, Item No. 100170 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
FDA Enforcement
Class II
·Terminated·Ameditech Inc·November 25, 2015
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013