15 results
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18ms
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Sources: EU EUDAMED, US FDA
TOMOSCAN STEREOTAXIS SIMULATION SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
EP1
FDA UDI
Smith & Nephew, Inc.·00885554007930·SOD FOOTSWITCH EP1 PEDAL STYLE
Lower ROC Pack for Herbst LR8 10mm
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199006600·
Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746136597·DB BRACKET MASTER SERIES MAND LEFT BICUSPID 4.0...
AIRWAY BALLOON CATHETER INFLATION DEVICE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413
FDA 510(k)
FDA Class 2
·Cardiovascular
LINER FOR METAL BACK GLENOID STANDARD
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWS·November 7, 2022
M2A MAGNUM SYSTEM CUP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·August 22, 2017
3.5MM 90ÿ° SERFAS ENERGY PROBE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code GEI·June 27, 2014
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 7, 2013
COLLEAGUE CXE VOLUMETRICINFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 16, 2010
Cesarean Pack, Catalog # 900-660 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OHM·October 8, 2014
Cesarean Pack, Catalog # 900-660 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
CESAREAN PACK 5/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
CESAREAN PACK- - (3) ABSORBENT TOWELS 15" x 20" LIF (1) PLASTIC BOWL WITH LID 80oz. (1 0) LAP SPONGES PRE-WASH 18" x 18" XRD (2) PAD OBSTETRICAL X-LARGE ST. (1) MAYO STAND COVER REINFORCED LIF (1) DRAPE SHEET 41" x 58" SMS LIF (2) TUBE SUCTION CONNECT. Y.." X 12' LIF (1) EAR ULCER SYRINGE 2oz. LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F (1) UMBILICAL CORD CLAMP (1) SURGICAL BLADE #20 CARBON STEEL (1) TABLE COVER REINFORCED 50" X 90" LIF (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF (1) DRESSING ISLAND 4" X 1 0" (1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78" (1) BABY BLANKET PRINTED (1) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) BAG SUTURE FLORAL 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