23 results
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35ms
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Sources: EU EUDAMED, US FDA
PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V
FDA 510(k)
FDA Class 2
·Cardiovascular
Sterling C2000
FDA UDI
SKYTRON LLC·10841736121754·C2000L 4 Level Instrument Rack
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950018574·FORCEP MOSQUITO HALSTED EXTRA LIGHT CURVED 4-3/...
Astra
FDA UDI
Preat Corporation·00842092129487·Astra®-compatible Lilac 4.5 X 9.0mm Closed-Tray...
FingerClip
FDA UDI
Honeywell Healthcare Solutions GmbH·04036616009942·FingerClip F-3211-31 MySign
BetaForce
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730022127·Beta3 Lower 018 10 archwires per pack
SCANLAN®
FDA UDI
SCANLAN INTERNATIONAL INC·00846159026313·Vascular Clamp with curved Hausmann Jaw
BetaForce™
FDA UDI
Ortho Organizers, Inc.·00190707124519·BETAFORCE Beta³ Lower .018 (10pk)
Battalion
FDA UDI
ALPHATEC SPINE, INC.·00840967188638·Battalion, LLIF Trial, 0°, 22 mm Wide, 04 mm X ...
WIN-1 TANGO
FDA 510(k)
FDA Class 2
·Physical Medicine
ZYBIT
FDA 510(k)
FDA Class 2
·Cardiovascular
IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·November 15, 2015
TECNIS SIMPLICITY
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·August 19, 2025
MICRODEBRIDER 1898200T IGS M4
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·May 15, 2014
UNOMETER 500 URINEMETERS
FDA Adverse Event
Malfunction
·UNOMEDICAL LTD.·Product code FFG·June 10, 2014
V-14? CONTROLWIRE®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DQX·March 13, 2013
PROPEX
FDA Adverse Event
Malfunction
·DENTSPLY MAILLEFER·Product code LQY·February 4, 2011
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 25, 2025
HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
FDA Recall
Terminated
·Vital Concepts, Inc.·Product code GCY·July 11, 2003
LAPAROSCOPY PACK CONTENTS: ( I ) BULB SYRINGE 60cc LIF ( I 0) GAUZE SPONGE 4" X 4" 1 6PLY XRD LIF ( I ) MAYO STAND COYER REINFORCED LIF ( I ) TABLE COVER REINFORCED 50" X 90" LIF (3) GOWN SURG. REINFORCED XL EXTRA LONG LEVEL I V (4) TOWEL ABSORBENT I 5" X 20" LIF ( I ) DRAPE VIDEO CAMERA I 3cm X 244cm LIF (3) LITE G LOVE LIF ( I ) DRAPE LAP ABDOM. WI POUCH 102" X 122" X 78" ( I ) BLADE SURG ICA L # II STAIN LESS STEEL ( I) SYRINGE I Occ W ITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE LIF ( I ) SUTURE BAG FLORAL (I) NEEDLE & BLADE COUNTER I OC MAG I C LEAR L/1' ( I ) CABLE LAP. IOFR 4MM MALE MONOP. LIF (2) DRESSING NON ADH TELfoA 4 X 3 ( I ) SPECIMEN CONTAINER 4oz WITH LID & LABEL (2) SH EET 'll.o 60" X 77" DRAPE R EI NFORCED LIF ( I ) TUBING INSUFFLAT SET WIO RING ADAPTOR LIF ( I ) CI-I LORAPREP 26ML APPLICATOR TEAL LIF ( I ) WRAPPER 24" X 24" (2) DENTURE CUP 8oz WILID ADHERED OUTSIDE OF THE PACK INTO A POUCH: ( I ) NEEDLE ULTRA VERES 1 20MM LIF ( I ) TROCAR ENDO.XCEL DILATING TIP IIM M (D IILT) ( I ) TROCA R ENDO.XCEL DILATING TIP LIF (K5LT) ( I ) CANNU LA 5MM XCEL SLEEVES LIF 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