17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS
FDA 510(k)
FDA Class 2
·Radiology
Macan
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950029747·ELECTRODE BLADE CURVED
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033371·Baltic Denture System BDLoad BDLoad ↓ Lw6 PLSEu...
INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MET1000, THC
FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918000740·INSTANT-VIEW Multi-Drugs of Abuse Urine Test CO...
UBIT-IR300 INFRARED SPECTROMETRY SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PUMP TUBING WITH X-COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CUERNAVACA·Product code KDI·April 3, 2013
ZOOM CRITICAL CARE BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·March 22, 2011
MIRA LUX MULTIFLEX TURBINE 635B
FDA Adverse Event
Injury
·KALTENBACH & VOIGT GMBH·Product code EKX·April 24, 2008
36MM I.D. SIZE II NEUTRAL LINER USE WITH 52MM O.D. SIZE II SHELL
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LZO·November 28, 2022
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDS·July 25, 2016
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDS·July 25, 2016
10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·March 23, 2015
TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Number:72200777
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021