18 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INFUSOMAT P
FDA 510(k)
FDA Class 2
·General Hospital
Premier Burnisher
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783009385·Burnisher DE_28/29
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040029428·Softline Chairside Reline Material Pk
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780145868·Integra® Jarit® Metal Base Cap, For REF#'s 600-...
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00530291·
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613153045038·RESECTION PLANE PROBE, SLOT 0.9MM
NITRILE PATIENT EXAMINATION GLOVE POWDER FREE, NON STERILE
FDA 510(k)
FDA Class 1
·General Hospital
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
FDA 510(k)
FDA Class 3
·Cardiovascular
ACIST
FDA Adverse Event
Malfunction
·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·August 1, 2013
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·March 13, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·February 28, 2011
2250051-2008-00089
FDA Adverse Event
Malfunction
·Product code JTC·February 11, 2008
Breast Pack BOD, code 900-3029, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL CAUTERY PUSH BOTTOM (1) SYRINGE BULB 60CC (1) TUBE SUCTION CONNECT%" X 12' (1) COUNTER NEEDLE/BLADE 20C FOAM/MAG (1) BOWL UTILITY QUART 32oz TURQ (1) COVER MAYO STAND REINFORCED (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER (1) COVER TABLE REINFORCED 50" X 90" (1) CUP DENTURE 8oz TEAL WITH LID (1) RULER (6) TOWEL CLOTH HUCK BLUE (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK (1) YANKAUER SUCTION TUBE WITHOUT VENT (1) DRAPE BREAST/CHEST (2) LITE GLOVE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
Bard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Pull", REF 003029, 20F, Sterile.
FDA Recall
Terminated
·C.R. Bard Access Systems, Inc·Product code KNT·December 4, 2008
BREAST PACK-BOD 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
FDA Enforcement
Class II
·Terminated·Customed, Inc·September 9, 2015
TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
FDA Enforcement
Class II
·Ongoing·Acclarent, Inc.·December 29, 2021
Breast Pack BOD, code 900-3029, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL CAUTERY PUSH BOTTOM (1) SYRINGE BULB 60CC (1) TUBE SUCTION CONNECT%" X 12' (1) COUNTER NEEDLE/BLADE 20C FOAM/MAG (1) BOWL UTILITY QUART 32oz TURQ (1) COVER MAYO STAND REINFORCED (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER (1) COVER TABLE REINFORCED 50" X 90" (1) CUP DENTURE 8oz TEAL WITH LID (1) RULER (6) TOWEL CLOTH HUCK BLUE (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK (1) YANKAUER SUCTION TUBE WITHOUT VENT (1) DRAPE BREAST/CHEST (2) LITE GLOVE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·May 20, 2014
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024