16 results
·
22ms
·
Sources: EU EUDAMED, US FDA
NASAL E.T. TAPE
FDA 510(k)
FDA Class 1
·Anesthesiology
NA
FDA UDI
Smith & Nephew, Inc.·00885554008524·MTO HOOK 3.0MM PROBE WITH HANDLE
DISPOSABLE CORING TREPHINE
FDA UDI
Biomet Orthopedics, LLC·00880304548503·
RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BSD3543W
FDA 510(k)
FDA Class 2
·Radiology
BIOLOX DELTA CER OPTION HD 36MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·March 26, 2026
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 27, 2014
UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·November 16, 2010
EON MINI
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 12, 2012
G7 NEUTRAL E1 LINER 36MM D
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·January 28, 2026
G7 FINNED 3 HOLE SHELL 50D
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·January 28, 2026
TLOC 133 MP SP T1 PPS HO 8X101
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·January 28, 2026
General Minor Pack, Catalog # 900-787 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·October 8, 2014
General Minor Pack, Catalog # 900-787 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
GENERAL MINOR PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
FDA Enforcement
Class II
·Terminated·Customed, Inc·September 9, 2015
GENERAL MINOR PACK- (1) MAYO STAND COVER REINFORCED LIF (2) BOWL UTILITY 16oz LIF (1) TIP CAUTERY POLISHER LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) BOWL UTILITY 32oz (1) BAG SUTURE FLORAL (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (10) GAUZE SPONGES 4" X 4" 16PLY XRD LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) GOWN IMPERVIOUS REINFORCED LARGE SMS LIF (1) CAUTERY PENCIL ROCKER SWITCH LIF (1) BLADE SURGICAL #10 STAINLESS STEEL (1) TUBE SUCTION CO NNECTING ~" X 12' LIF (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (2) LITE GLOVES LIF (1) DRAPE LAPAROTOMY WITH POUCH 102" X 121" X 78" STD SMS (4) DRAPE UTILITY WITH TAPE LIF (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) BLADE SURGICAL #15 CARBON STEEL (2) SHEET DRAPE 41" X 69" MEDIUM LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF 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