30 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Capsulo
FDA 510(k)
FDA Class 2
·Ophthalmic
KeyPrint
FDA UDI
Keystone Industries·H66842204301·KeyDenture Base Original 1kg
NA
FDA UDI
DEPUY MITEK, LLC·10886705007202·Cortical Screw 4.5mm x 30mm
ELMED
FDA UDI
ELMED INCORPORATED·00842180136878·4MM DIA., 30CM, ELMED HD LAPAROSCOPE, 30 DEGREE
DeBakey-Beck Aortic Clamp 19.5cm
FDA UDI
Geister Medizintechnik GmbH·04057034055892·DeBakey-Beck Aortic Clamp 19.5cm
Vercise™ Cartesia™ HX
FDA UDI
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·08714729966357·Directional Lead Kit, 16 Contact, 30cm
MICROLIFE WRIST WATCH BLOOD PREEURE MONITOR, BP3MO1-3P
FDA 510(k)
FDA Class 2
·Cardiovascular
DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYNCRHOMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·November 4, 2008
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 23, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022
SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022
BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
FDA Enforcement
Class II
·Terminated·Bard Peripheral Vascular Inc·January 1, 2020
Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)00889024479500 (17)220430 (10)2905496
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code LZO·February 28, 2018
Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022
LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022
Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
FDA Recall
Open, Classified
·CP Medical Inc·Product code GAM·October 18, 2019
LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022
SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022