12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
MEGASON MODEL 150
FDA 510(k)
FDA Class 2
·Physical Medicine
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814176·GENUMEDI PT SILVER R I
WILLI GELLER CREATION CP PORCELAIN
FDA 510(k)
FDA Class 2
·Dental
Schoelly Laparoscope
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LUMBAR DECOMPRESSION (ISLD70)
FDA Adverse Event
Injury
·AMERICAN CONTRACT SYSTEMS·Product code OJG·August 8, 2022
LUMBAR DECOMPRESSION (ISLD70)
FDA Adverse Event
Injury
·AMERICAN CONTRACT SYSTEMS·Product code OJG·August 8, 2022
LUMBAR DECOMPRESSION (ISLD70)
FDA Adverse Event
Injury
·AMERICAN CONTRACT SYSTEMS·Product code OJG·August 8, 2022
PROPAQ MD DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code LDD·March 21, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·November 21, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·September 24, 2010
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 22, 2020
Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; b) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; c) MINI MINOR AGH ASC PACK, kit number AGMM60M; d) OUTPATIENT PORT ACCESS KIT 307907, kit number AHPO55J; e) General Pack, kit number BBGP31C; f) FRACTURE TABLE PACK, kit number FDFT75N; g) Arthroscopy Pack, kit number HCAR04K; h) BARIATRIC PACK, kit number HGBA92F; i) LAPAROTOMY PACK, kit number HNLP12J; j) MIDLINE CHANGE KIT, kit number HSMD20E; k) Minor General, kit number JSMI10I; l) ENDO VASCULAR PACK, kit number LVEV61; m) MAJOR PACK, kit number LVMJ21; n) HEAD AND NECK PACK, kit number MMHN37F; o) KIT, MINOR U BAR, kit number MMNU34E; p) KIT, MAJOR UNIVERSAL, kit number MMUN28E; q) VAG PLASTY PACK, kit number OSVP16; r) DR L MAJOR, kit number SALM40H; s) DR L MAJOR, kit number SALM40I; t) MINOR BASIN SAH, kit number SAMB25E; u) MAJOR SAH, kit number SAMJ36G; v) MINOR PACK, kit number SMMN65; w) General Pack, kit number THGN59D; x) MINOR PACK, kit number TPMN15; y) MAJOR UNIVERSAL PACK, kit number TPUN48
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·February 7, 2024