22 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Dental
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001238·artVeneer life upper anteriors, BOL, B3
BD PLASTIPAK¿ LUER-LOK¿ 30 ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·September 30, 2020
LIFEPAK® 15 monitor/defibrillator
FDA UDI
PHYSIO-CONTROL, INC.·00883873911815·15AAAAAAAAABBAAAAAAAAAABLP15 MONITOR/DEFIB
N/A
FDA UDI
Doppkon GmbH & Co. KG·04262494462603·Femoral Aimer
OD 6.0mm, WL 155mm
SYRINGE 30ML LL
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·January 19, 2021
I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354
FDA 510(k)
FDA Class 2
·Cardiovascular
HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G
FDA 510(k)
FDA Class 2
·Microbiology
N/A
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024369818·I.V. POST WITH CLAMP 22 INCHES, DIAMETER 19MM
N/A
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024369771·I.V. POST WITH CLAMP 10 INCHES, DIAMETER 13MM
N/A
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024369795·OFFSET DOUBLE CLAMP BAR 31 INCHES
N/A
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024369825·ANGLED I.V. POST W/CLAMP 23 INCHES, DIAMETER 19MM
N/A
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024369801·ANGLED I.V. POST WITH CLAMP 19 INCHES, DIAMETER...
N/A
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024369764·I.V. POST WITH CLAMP 19 INCHES, DIAMETER 13MM
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP·Product code LLZ·February 26, 2013
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 24, 2011
V-CARE
FDA Adverse Event
Malfunction
·CONMED CORPORATION·Product code LKF·February 22, 2008
OB PACK - (2) EXAM GLOVES MED. (1 0) GAUZE SPONGES 4" X 4" 12PL Y (2) LEGGINS W/ 7" CUFF (2) DRAPE SHEET SMS (1) ABDOMINAL DRAPE W/TAPE (1) PLASTIC BOWL W/Lid 70 oz. (1) EAR/ULCER SYRINGE 2oz. L/Free (1) UMBILICAL CORD CLAMP (1) BABY BEANNIES (1) PVP SCRUB 8" STICK SPONGES (1) MEASURE DISP. PAPER TAPE 24" (1) IMP .REINFORCED GOWN XLge. SMS STERILE (1) TABLE COVER Reinf. L/Free (1) SYRINGE 1cc W/NDL. 25G X 5/8 SLIP TIP L/Free (2) PAD OBSTETRICAL XLGE ST. (1) UNDERBUTTOCK DRAPE W/POUCH (1) SYRINGE 10cc W/0 NDL. L/Free (1) SYRINGE 20cc W/ONDL. L/Lock L/Free (1) FEEDING TUBE 8 Fr. 15" LONG (1) BABY BLANKET IMP. POLY ABS. (1) NEEDLE HYPODERMIC 23GA X 1" (6) ABSORBENT TOWELS L/Free (1) WRAPPER 24" X 24" 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
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Llc·February 5, 2014