FDA 510(k) clearances — page 624
clearances on record, most recent first.
Clearances — page 624
62,301–62,400 of 176,637- K062020 — LIFESOUND ESOPHAGEAL STETHOSCOPE
- K062159 — RB12 SUCTION RECTAL BIOPSY SYSTEM
- K062281 — ZIMMER ONE-PIECE IMPLANT, 4.7MM, STRAIGHT, MODELS ZOP47S10, ZOP47S11, ZOP47S13, ZOP47S16
- K062504 — CERAMAX
- K060165 — AXYAFLEX POLYESTER SUTURE
- K060288 — RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS
- K060882 — EXCEL BOND DC, MODEL 28-200100
- K061075 — BOOMERANG WIRE
- K061134 — EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES
- K061231 — WELLFLEX BILIARY RX STENT SYSTEM
- K061564 — PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD
- K061649 — POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH
- K061797 — SM IMPLANT SYSTEMS
- K062223 — AGFA MODEL CR30-X
- K062290 — MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML)
- K062307 — XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS
- K062317 — MODIFICATION TO NUVASIVE SPHERX II SYSTEM
- K062326 — AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE
- K062393 — GE VANTAGE PET NEURO SOFTWARE
- K062430 — HEMOSIL PROTEIN C
- K062431 — HEMOSIL LIQUID ANTITHROMBIN
- K052687 — CONFORMIS, INC. TOTAL KNEE REPAIR SYSTEM
- K053556 — BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5
- K060397 — RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED
- K061045 — REPROCESSED ELECTROPHYSIOLOGY CATHETERS
- K061248 — AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM
- K061313 — EVIS EXERA 180 SYSTEM
- K061555 — ANCHOR LAPARSCOPIC TISSUE RETIEVAL SYSTEM
- K061566 — PRIMUS GPS BILIARY STENT SYSTEM
- K061870 — VITALSENSE XHR
- K061970 — ELECSYS IGE II IMMUNOASSAY
- K062190 — SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
- K062230 — MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002
- K062231 — MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001
- K062299 — SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT
- K060578 — CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)
- K061353 — TRINICA ANTERIOR LUMBAR PLATE SYSTEM
- K061531 — SPACE CPSXL BONE CEMENT
- K061686 — IDI-VANR ASSAY
- K061071 — V-808 ATOM TRANSCAPSULE
- K061236 — FLEXIFIT HC432 FULL FACE MASK
- K061839 — DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125
- K061221 — DUPUY S-ROM STD HIP STEM PROSTHESIS
- K061799 — QUADRATENS, MODEL QT-42
- K061862 — AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM
- K061917 — DISTAL RADIUS LOCKING PLATING SYSTEM
- K062158 — LC SPRINT STAR
- K062175 — CRYOCARE CN2 SYSTEM
- K062225 — HALO COAGULATION CATHETER
- K053451 — LIPOSAT (INFILTRATION PUMP), MODEL 00 002 274; VACUSAT (SUCTION UNIT), MODEL 00 002 252 (220 V), 00 002 318 (110 V)
- K060677 — N LATEX CDT
- K060720 — CURATIVE DENTAL ACRYLIC TEETH
- K061293 — TELAHEART DIGITAL RECORDER
- K061701 — HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H)
- K061719 — DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212
- K061738 — ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD
- K061923 — DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310)
- K062036 — MICRUS MICROCOIL SYSTEM PRESIDIO-18, MODEL PC4
- K062088 — PREMIER 11 HOLTER
- K062121 — DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420)
- K062122 — DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130)
- K060072 — MONOBLOCK PRESS-FIT HIP STEM
- K060854 — ABX PENTRA 400: LIPOPROTEINS
- K060958 — STRAUMANN NARROW NECK IMPLANTS
- K061194 — PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 432558
- K061289 — ARROW PRESSURE INJECTABLE PICC
- K061325 — BODYGAURD PAIN MANAGER INFUSION SYSTEM
- K061551 — POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS)
- K061666 — CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600; COLOFLEX AND GASTROFLEX
- K061689 — AQUATINE EC ENDODONTIC CLEANSER
- K061733 — ANGIODYNAMICS SOFT-VU AND MARINER HYDROPHILIC COATED ANGIOGRAPHIC CATHETER
- K061845 — DIMENSION VISTA IGM FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H
- K062137 — MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30
- K062140 — SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1
- K062169 — APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS
- K062293 — MICROSCAN MICROSTREP PLUS PANEL CHLORAMPHENICOL (1 TO 32 MCG/ML)
- K062381 — CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR
- K060773 — ONLINE TDM PROCAINAMIDE
- K061246 — ENDOSCOPIC SPINE SYSTEM
- K061529 — PROCERA ZIRCONIA ABUTMENT FOR CAMLOG IMPLANT SYSTEM
- K061674 — RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER
- K061872 — MICROSCAN MICROSTREP PLUS PANEL
- K062145 — MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90
- K062173 — MODIFICATION TO BONE GRAFT SYRINGE
- K062179 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.25 - 16UG/ML)
- K062245 — HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936
- K062276 — MICROSCAN MICROSTREP PLUS PANEL
- K062298 — APOLLO GAMMA CAMERA SYSTEM
- K060911 — CG-6108 ARRHYTHMIA ECG EVENT RECORDER
- K061369 — TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500
- K061434 — TRIDENT LARGE DIAMETER HIP SYSTEM
- K061600 — ARX SPINAL SYSTEM
- K061628 — JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL HMOD 2030
- K061866 — NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS
- K061959 — MYTECH / HAPPY LIFE / MAXIAIDS ARM BLOOD PRESSURE MONITOR, HPL-301, HPL-302, HPL-310, 180310
- K062134 — VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
- K062170 — BIOKNOTLESS AND LUPINE PLUS ANCHORS
- K053555 — ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L
- K060727 — VECTORVISION HIP
- K061433 — VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE
Data sourced from openFDA. This site is unofficial and independent of the FDA.