19 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HORIZON SURGICAL LIGATING AND MARKING CLIP
FDA 510(k)
FDA Class 2
·Cardiovascular
24 Fr Infant Flexi Tip: Pediatric Enema Tip
FDA UDI
Bracco Diagnostics Inc.·10815112021624·Infant Flexi Tip
24 Fr Infant Flexi Tip: Pediatric Enema Tip
FDA UDI
Bracco Diagnostics Inc.·10815112021013·Infant Flexi Tip
POWER CUT PREPARATION SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·B09929013030·POWER CUT PREPARATION SCISSORS CURVED DOUBLE-AC...
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756094337·SLING & SWATHE
ShurFit MALIF System
FDA UDI
PRECISION SPINE, INC.·00840019925242·Cup Curette 4mm 90˚ Up Pulling
LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV
FDA 510(k)
FDA Class 2
·Hematology
BREAST IMMOBILIZATION DEVICE MR-BY 160
FDA 510(k)
FDA Class 2
·Radiology
IV SET AN120 W/O BP
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·May 9, 2019
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014
PREFYX PPS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code FTL·January 8, 2013
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 17, 2010
ACTIVELIFE
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EZQ·February 10, 2020
ACTIVELIFE
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EZQ·February 10, 2020
ACTIVELIFE
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EZQ·February 10, 2020
ACTIVELIFE
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EZQ·February 10, 2020
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40; b) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP45; c) PAED. TRACHEOSTOMY TUBE 5.0MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP50; d) PAED. TRACHEOSTOMY TUBE 5.5MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021