17 results
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24ms
·
Sources: EU EUDAMED, US FDA
Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813034606·K-Type Files 21MM #45-80
POSIFLUSH
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·April 20, 2026
100W CERALAS D 980 LASER SYSTEM, MODEL D100
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TD-Wand
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POSIFLUSH
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·May 1, 2026
BD POSIFLUSH
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code NGT·March 20, 2026
BD POSIFLUSH
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code NGT·March 20, 2026
POSIFLUSH
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FOZ·April 6, 2026
ACCUSURE
FDA Adverse Event
Malfunction
·FEEL TECH·Product code FMF·November 29, 2008
DEPUY ASR HIP IMPLANT
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS·Product code KWA·September 1, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·July 29, 2013
BIOLOX DELTA CERAMIC FEM HD 36/0MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·May 28, 2024
Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To assist in inserting catheters, introducer sheaths, and other medical devices in vascular applications.
FDA Enforcement
Class I
·Terminated·Cook Inc.·November 11, 2020
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.
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
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021