FDA 510(k) clearances — page 662
clearances on record, most recent first.
Clearances — page 662
66,101–66,200 of 175,825- K042058 — ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN
- K042672 — 14F DUAL FLOATING DIALYSIS CATHETER/TRAY
- K042715 — TITAN DENTAL IMPLANT ATTACHMENT
- K043344 — DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM
- K043393 — REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS
- K050235 — IQ 200 URINE ANALYZER BODY FLUIDS MODULE
- K050442 — MILLENNIUM MULTI-LEAF COLLIMATOR
- K050591 — MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS
- K043033 — GLOBAL TREASURES FLUID FILLED TEETHER
- K043225 — VANGUARD REPROCESSED ULTRASONIC SCALPEL
- K043315 — VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL
- K043361 — ACCUHEART ELECTRODE BELT
- K050037 — TRIAGE TOX DRUG SCREEN CONTROLS
- K050074 — 12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200
- K050139 — MODIFICATION TO: EXPORT CATHETER
- K050400 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GP) 0.5-64 UG/ML
- K050551 — VOYAGER PERSONAL IMAGING DEVICE
- K050584 — GS-128 GRADIENT COMPRESSION SYSTEM
- K050627 — LIFESTENT TURBO BILIARY STENT SYSTEMS
- K050630 — PIVOT STEERABLE MICROCATHETER
- K042418 — KD-575 MEMORY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
- K042482 — BASS ANTALGIC-TRAK
- K042999 — CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8
- K043488 — MODIFICATION TO CD HORIZON SPINAL SYSTEM
- K043497 — AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OV
- K050138 — MODIFICATION TO: RESTORATION MODULAR SYSTEM
- K050354 — PERIOSCAN ULTRASONIC SCALER
- K050512 — STRYKER LOCKED PLATING SYSTEM
- K050634 — MODIFICATION TO: ARTHREX V-TAK
- K033577 — UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS
- K041311 — TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES)
- K042208 — ISIS MER SYSTEM/ELEKTA MER SYSTEM
- K042523 — RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES
- K042727 — POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A
- K042887 — ACCU-CHEK SPIRIT
- K042972 — XP TECHNOLOGY ULTRASONIC SCALER
- K043329 — OMNILUX REVIVE AND BLUE
- K043571 — CRYOCHECK CLOT S
- K050021 — VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
- K050125 — RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4
- K050137 — TEMPTOUCH DERMAL THERMOMETER
- K050201 — AEU-14CF EXPENDITION
- K050237 — STARSHIELD V3 RF TRNT
- K050293 — FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS
- K050422 — 550 TXT TREATMENT TABLE
- K050426 — TEMPOSIL, MODEL 6720
- K050527 — POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABL
- K050531 — POWDERED NITRILE EXAMINATION GLOVES (BLUE,WHITE)
- K050585 — MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE
- K040262 — DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX
- K043436 — NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269
- K043451 — BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR
- K050084 — COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT;
- K050195 — V-BAG WITH GBS COATING
- K050211 — PERSONAL WARMING GEL
- K050212 — PERSONAL WARMING JELLY
- K050255 — ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4
- K050346 — STABILIZATION SCREW
- K050366 — IMAGENPRO
- K050535 — STRYKER MMF SCREW
- K050559 — GE DISCOVERY VCT SYSTEM
- K032666 — MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES
- K033436 — REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER
- K041541 — COMPEL MLR SURGICAL GOWNS
- K041626 — IMMUNOCARD STAT! FLU A & B
- K042344 — EXCIA TOTAL HIP SYSTEM
- K042699 — ABILITY POWER GURNEY
- K042899 — SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS
- K042901 — ENDOMARK STERILE INDIA INK
- K043004 — STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031
- K043021 — STRYKER URETEROSCOPE
- K043292 — HEMOCATH
- K043401 — SPECTRANETICS LLD CS, MODEL 518-039
- K043491 — ENFANTTM
- K050091 — TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE)
- K050184 — BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE
- K050214 — NITRILE POWDER FREE EXAMINATION GLOVES (WHITE)
- K050316 — AEQUALIS REVERSED SHOULDER PROSTHESIS
- K050359 — ULTRA MIRAGE II MASK
- K050529 — POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTER
- K050530 — POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN)
- K040883 — EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM
- K043022 — STRYKER FLEXIBLE CYSTONEPHROSCOPE
- K043317 — OMNILUX PLUS
- K043458 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTETAN (GN) 2-64 UG/ML
- K050112 — PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117
- K050145 — CELLTRACKA ANALYZER II
- K050206 — CEDIA TACROLIMUS ASSAY
- K050245 — CELLSEARCH CIRCULATING TUMOR CELL KIT
- K050362 — VITA PM 7 (20 GRAM BOTTLES), VITA PM 7 (50 GRAM BOTTLES)
- K050378 — SYNTHES MANDIBLE EXTERNAL FIXATOR
- K041781 — VENTILAIR II MEDICAL AIR COMPRESSOR
- K042169 — STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER
- K042515 — SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE
- K042711 — MODEL BMLS03-7
- K043058 — PINNACLE CONSTRAINED ACETABULAR LINERS
- K043144 — GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE
- K043511 — SOLEUS POWERED WHEELCHAIR, MODEL FAD-2
- K043570 — UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD
- K050042 — WU'S 4-WHEELED NEO SCOOTER, WT-XL4
Data sourced from openFDA. This site is unofficial and independent of the FDA.