FDA 510(k) clearances — page 420
clearances on record, most recent first.
Clearances — page 420
41,901–42,000 of 175,770- K123918 — MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATE SYSTEM
- K130049 — MONOJECT 12ML SYRINGE
- K130055 — ACON BUP ONE STEP BUPRENORPHINE TEST STRIP
- K120236 — TRANSFERRIN KIT FOR USE ON THE SPAPLUS
- K121826 — INTEGRA PROXIMAL HUMERAL PLATE SYSTEM
- K123097 — DOSE TRACKING SYSTEM MODEL XIDF-DTS801
- K123254 — ULTRASOUND SCANNER FLEX FOCUS
- K123412 — RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS
- K123524 — MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
- K113236 — FORYOU NPWT DEVICE
- K113614 — ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
- K120663 — MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI
- K121877 — GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES
- K122925 — NEW STETIC ARTIFICIAL TEETH
- K123544 — RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER
- K123705 — TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS
- K123938 — SYNGO MR B19 FOR MAGNETOM AVANTO, SYNGO MR B19 FOR MAGNETOM ESPREE, SYNGO MR B19 FOR MAGNETOM SYMPHONY A TIM SYSTEM, SYN
- K130043 — PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
- K130090 — STA COMPACT MAX
- K130209 — INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED
- K102751 — LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM
- K121069 — 3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK
- K122411 — J-SCOPE SYSTEM
- K123116 — CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR)
- K123435 — IPL THERAPY SYSTEM
- K123450 — PHONAK TINNITUS BALANCE
- K123494 — SOLEA
- K123620 — FILMARRAY RESPIRATORY PANEL (RP)
- K130132 — BABYLANCE HEEL INCISION DEVICE
- K112616 — NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS
- K113268 — ALEXIS O WOUND PROTECTOR/RETRACTOR
- K121280 — MYOSURE INTRUMENT TRAY
- K121565 — UNI-GOLD CRYPTOSPORIDIUM
- K121942 — ADENOVIRUS R-GENE US
- K122065 — DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE
- K122386 — VICTUS FEMTOSECOND LASER PLATFORM
- K122810 — COMPACT DIGITAL BLOOD PRESSURE MONITOR
- K123023 — SURGERY REHEARSAL PLATFORM
- K123131 — ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI
- K123249 — DIAGNOSTIC ULTRASOUND SYSTEM
- K123308 — PULSTAR LOGIX INTERMITTENT PNEUMATIC COMPRESSION SYSTEM
- K123488 — LINSHI NITRILE DISPOSABLE EXAM GLOVES, POWDER-FREE
- K123596 — OPTIMA CT520
- K123688 — PROFEMUR TL CLASSIC HIP STEM
- K123799 — PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR
- K130070 — 4MP COLOR LCD MONITOR, RADIFORCE RX440
- K130103 — CORONIS FUSION 6MP
- K120558 — ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION
- K120701 — M2 WRIST MRI SYSTEM
- K120708 — ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM
- K120922 — GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT
- K121050 — 0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE
- K121818 — OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE
- K122554 — GENASIS SCANVIEW SYSTEM
- K122587 — BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208
- K122633 — TOXCUP DRUG SCREEN CUP
- K122822 — SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM
- K122871 — COMPRESSYN STAPLE
- K123206 — MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM
- K123216 — AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN
- K123232 — SPINEOLOGY SPINOUS PROCESS PLATE
- K123521 — RELIANCE SPINAL SCREW SYSTEM
- K123969 — XIPHOS
- K130057 — ESPIN
- K121409 — ASAHI REXEED-SX/LX SERIES DIALYZER
- K122718 — BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP
- K122879 — EEGER4 MODEL 4.3
- K123125 — GE DATEX-OHMEDA AVANCE CS2
- K123326 — SHERPA PAK CARDIAC TRANSPORT SYSTEM
- K123460 — TRC-NW300 NON-MYDRIATIC RETINAL CAMERA
- K123865 — VISUAL-ICE CRYOABLATION SYSTEM
- K123970 — CAAS INTRAVASCULAR
- K123992 — APLIO 500/400/300 V3.0
- K130041 — SHEATHES STERILE ULTRASOUND GEL
- K121453 — A-GRIX TE RESORABLE BONE VOID FILLER
- K122183 — AUGMENT AND SCREW, PSA TYPE
- K122520 — DIGITAL THERMOMTER
- K122781 — RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD
- K122805 — PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR
- K123050 — EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)
- K123114 — ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE
- K123138 — PASS LP SPINAL SYSTEM
- K123215 — VISCOSTAT CLEAR
- K123217 — CARDEASCREEN
- K123309 — GIRAFFE AND PANDA WARMERS
- K123434 — PROFEMUR Z CLASSIC STEMS
- K130016 — LIFESPAN EPTFE VASCULAR GRAFT
- K120804 — CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM
- K122046 — WRIST PULSE OXIMETER
- K123170 — VARI-PASS VARIABLE LENGTH ACCESS SHEATH
- K123704 — AUTOMATED ENDOSCOPE LEAK TESTER
- K111275 — CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE
- K113504 — DEKA SMARTXIDE AND DELIVERY ACCESSORIES
- K121327 — DIOLASE 10S
- K121418 — PLANMED VERITY
- K121456 — AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL
- K121985 — ARCHITECT TOTAL BILIRUBIN
- K122081 — NUVASIVE LONG LATERAL SPINAL SYSTEM
- K122159 — DORNIER MEDILAS H30 SOLVO
- K122550 — ICS IMPULSE
Data sourced from openFDA. This site is unofficial and independent of the FDA.