15 results
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26ms
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Sources: EU EUDAMED, US FDA
IRON LIQUID STABLE REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
R900902
Device
EU MDR
·
Eu Md Class 1
·GH Innotek Co., Ltd.·On the market
SCANLAN® MicroSurgical Instruments
FDA UDI
SCANLAN INTERNATIONAL INC·00846159023541·Sartor Tunneler
BONE-LOK MVP Cortical-Cancellous Compression Device
FDA UDI
INTERVENTIONAL SPINE, INC·81195401187162·4.5mm Diameter x 40-50mm Length
SPIDER SINGLE PORT SURGICAL DEVICE, SUPPORT ARM ACCESSORY, MODEL 90001, 90002, 90003
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KLINIDRAPE REINFORCED SURGICAL GOWNS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STAT DL 9.5 FR. 40 CC. IAB
FDA Adverse Event
Death
·DATASCOPE CORP.·Product code DSP·July 2, 1999
ZOLL IVTM THERMOGARD XP
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC·Product code NCX·June 27, 2014
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·January 2, 2013
I-STAT 1 ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE INC.·Product code JJE·November 9, 2010
Arthroscopy Pack, Catalog # 900-902 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 FWZ·October 8, 2014
Arthroscopy Pack, Catalog # 900-902 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
ARTHROSCOPY PACK 3/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
ARTHROSCOPY PACK- (2) ABSORBENT TOWELS 15" x 20" LIF (1) TUBE SUCTION CONNECT Y.." X 12' LIF (1) ELASTIC BANDAGE 6" X 5yrd. UF (1) IMPERVIOUS STOCKINETTE 14" X 48" (1) HUCK CLOTH TOWEL WHITE (1) MAYO STAND COVER REINFORCED LIF (1) U DRAPE 60" X70" WITH TAPE SPLIT (4) STRIPS TAPE 24" X 4" L/F (1) STOCKINETTE 6" X 48" LIF (1) MAYO TRAY SMALL (5) HUCK CLOTH TOWELS BLUE (2) UTILITY BOWL 32oz (2) GOWN SURGICAL REINFORCED X-LARGE LEVEL IV (1) SOLUTION SURGICAL DURAPREP 26ml UF (1) SHEET EXTREMITY ABS. 125" x 85" SMS (5) LAP SPONGE PREWASH XRD (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) PENCIL CAUTERY ROCKER SWITCH (1) SKIN MARKER INK WITH 8 LABEL (2) LITES GLOVES UF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR (1) CAUTERY TIP POLISHER UF (4) DRAPE UTILITY WITH TAPE UF (1) BAG BIOHAZARD 30" X 37" (1) BAG SUTURE FLORAL (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE UF (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL/WRAP 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
SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, 459801585212.
FDA Enforcement
Class I
·Ongoing·Philips North America Llc·July 3, 2024