24 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HARDYDISK CEFOTETAN, 30MCG
FDA 510(k)
FDA Class 2
·Microbiology
RANDOX PREALBUMIN
FDA 510(k)
FDA Class 1
·Immunology
A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
INSET GUARD
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·March 30, 2026
INSET GUARD
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·March 30, 2026
Z.S.G.M. CUTTER 1.5:1 RATIO ( CAUTION: SHARP )
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code FZW·July 11, 2023
Z.S.G.M. CUTTER 2:1 RATIO ( CAUTION: SHARP )
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code FZW·July 11, 2023
NEW LIGASURE 5MM
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GEI·February 13, 2013
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·February 28, 2011
ACCU-CHEK COMPACT PLUS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·February 8, 2008
STERNALOCK BLU SYSTEM SCREW, CANCELLOUS CROSS-DRIVE LOCKING 2.4 X 16MM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·May 10, 2018
ELEVATOR #301
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code EMJ·June 2, 2016
ELEVATOR #301
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code EMJ·June 2, 2016
OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY
FDA Adverse Event
Malfunction
·OGDEN MANUFACTURING PLANT·Product code KDI·July 21, 2018
OPTIFLUX 180NRE DIALYZER FINISHED ASSMBLY
FDA Adverse Event
Malfunction
·OGDEN MANUFACTURING PLANT·Product code KDI·August 13, 2018
OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY
FDA Adverse Event
Malfunction
·OGDEN MANUFACTURING PLANT·Product code KDI·July 27, 2018
Tummy Tuck & Liposuction Pack, catalog #900-2661 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
Tummy Tuck & Liposuction Pack, catalog #900-2661 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
Tummy Tuck and Liposuction Pack, code 900-2661, contains: ( 1) DRAPE % ECONOMY 53 X 77 (3) GOWN SOFT SMS STANDARD X-LARGE SET IN SLEEVE (3) TOWELS ABSORBENT 15 X 20 (1) MAYO STAND COVER REINFORCED (1) TABLE COVER REINFORCED 50 X 90 ( 1) SUTURE BAG FLORAL (6) TOWEL CLOTH HUCK BLUE (1) BLADE SURGICAL CARBON STEEL 10 (1) BLADE SURGICAL CARBON STEEL 11 (4) PAD ABDOMINAL 8 X 7.5 ( 1) CAUTERY TIP POLISHER (2) LITE GLOVES ( 1) YANKAUER SUCTION TUBE WITHOUT VENT (20) LAP SPONGE PREWASH 18 X 18 XRD (1) CAUTERY PENCIL ROCKER SWITCH WITH HOLSTER (1) UNDERPAD 23 X 36 ( 1) TUBE SUCTION CONNECT 1/4 X 12 (1) DRAPE BREAST/CHEST SMS Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·May 20, 2014
Tummy Tuck and Liposuction Pack, code 900-2661, contains: ( 1) DRAPE % ECONOMY 53 X 77 (3) GOWN SOFT SMS STANDARD X-LARGE SET IN SLEEVE (3) TOWELS ABSORBENT 15 X 20 (1) MAYO STAND COVER REINFORCED (1) TABLE COVER REINFORCED 50 X 90 ( 1) SUTURE BAG FLORAL (6) TOWEL CLOTH HUCK BLUE (1) BLADE SURGICAL CARBON STEEL 10 (1) BLADE SURGICAL CARBON STEEL 11 (4) PAD ABDOMINAL 8 X 7.5 ( 1) CAUTERY TIP POLISHER (2) LITE GLOVES ( 1) YANKAUER SUCTION TUBE WITHOUT VENT (20) LAP SPONGE PREWASH 18 X 18 XRD (1) CAUTERY PENCIL ROCKER SWITCH WITH HOLSTER (1) UNDERPAD 23 X 36 ( 1) TUBE SUCTION CONNECT 1/4 X 12 (1) DRAPE BREAST/CHEST SMS 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