12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ER36 Series OAE Test System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768451·GENUMEDI PSS GREEN I
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304240070·
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100141·KRATZ-BARRAQUER HEAVY WIRE SPECULUM
BACKSTOP CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KA, HL888LF & HL888IF
FDA 510(k)
FDA Class 2
·Cardiovascular
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 6, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
HOWMEDICA/OSTEONICS
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS·Product code KWY·August 22, 2008
Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823
FDA Enforcement
Class II
·Terminated·Cook Inc.·February 12, 2020
Biomet OSS Interlok IM Stem w/Screw, straight collar, 13 mm x 225 mm, TI6AL4V alloy, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 150491. Orthopedic implant intended as part of a replacement knee joint.
FDA Recall
Terminated
·Biomet, Inc.·Product code KRO·May 15, 2008
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015