23 results
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50ms
·
Sources: EU EUDAMED, US FDA
OptiVu Shoulder
FDA 510(k)
FDA Class 2
·Neurology
Happy Planet Bamboo Toothbrush - Kids
FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063755826·Happy Planet Bamboo Toothbrush - Kids, imprinte...
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780187516·Integra® Jarit® Hibbs Chisel, 9-3/4", Straight,...
Bradshaw Medical Inc.
FDA UDI
Bradshaw Medical, Inc.·00810019930867·BIT, HEX MALE 6.0MM 1/4 SQ
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756027908·Needle Counter
TASTES GREAT
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730004376·Alginate Flavoring Pina Colada 2 fl oz per bottle
Stainless Steel Goldtone Archwire
FDA UDI
Ortho Arch Company Inc·D90925010813·.019 x .025 STAINLESS STEEL ARCHES RIGHT FORM G...
Kleiner KG2 system
FDA UDI
Baat Medical Products B.V.·08720246782752·Trial
Reverse Medical Micro Vascular Plug System
FDA 510(k)
FDA Class 2
·Cardiovascular
SUREFLEX AND ACCUFLEX LASER LITHOTRIPSY FIBERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NIM-ECLIPSE® CONTROLLER
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code GWF·December 9, 2014
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·November 14, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 15, 2011
ORBIT GALAXY DETACHABLE COIL SYSTEM
FDA Adverse Event
Injury
·CODMAN AND SHURTLEFF, INC·Product code HCG·July 26, 2013
MICROVASCULAR PLUG
FDA Adverse Event
Injury
·REVERSE MEDICAL·Product code KRD·September 8, 2021
MICROVASCULAR PLUG
FDA Adverse Event
Injury
·REVERSE MEDICAL·Product code KRD·September 8, 2021
RAYONE GALAXY
FDA Adverse Event
Malfunction
·RAYNER INTRAOCULAR LENSES LIMITED·Product code HQL·January 28, 2025
STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator. 10134 Sterrad 100NX Express Cycle Kit. 10135 Sterrad 100NX Express Cycle Upgrade Kit. 10137 Sterrad 100NX Duo Cycle Upgrade kit. 14325 Cyclesure Challenge Pack Kit. 20103 Sterrad 100NX Test Pack Kit. 20228 Sterrad 100NX Intl Validation Kit. 20229 Sterrad 100NX Validation Kit, USA. 20232 Sterrad 50/100S Validation Kit. 20236 Sterrad 50/100S Validation Kit. 20248 Sterrad 100NX Express Validation Kit. 20253 Sterrad NX Validation Kit. 20254 Sterrad NX Validation Kit Domestic, US. The Sterrad Cyclesure 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilization System cycles.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·December 19, 2012
BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020