FDA 510(k) clearances — page 640
clearances on record, most recent first.
Clearances — page 640
63,901–64,000 of 176,637- K060373 — COBAS 6000 SERIES SYSTEM
- K060393 — INION HEXALON BIODEGRADABLE ACL/PCL SCREW
- K060419 — CONCERTO BIPOLAR NEEDLE ELECTRODE
- K060491 — QUANTUM ANTERIOR CERVICAL PLATE SYSTEM
- K060534 — INTUITIVE SURGICAL SEAL
- K051128 — ELECTROPULSE
- K051477 — MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC)
- K052212 — MIGUE
- K052839 — CT PERFUSION 4
- K053102 — BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE
- K053284 — MAGBODY DT-600
- K053335 — PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480
- K053398 — COMPASS COMPRESSION ASSIST HANDLE
- K053511 — DA VINCI FEMTOSECOND SURGICAL LASER
- K060032 — RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053
- K060178 — VIX WIN PRO
- K060208 — CAREO SAFETY SYRINGE 1CC/ML, MODELS CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C,
- K060349 — PROGUIDE NEEDLE SET
- K060433 — DIGITAL RADIOGRAPHY CXDI-50C
- K060513 — SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.X
- K051839 — FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001
- K052207 — ACCUREX GLUCOSE TEST STRIP
- K053194 — NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE
- K053280 — PROBEAT
- K053485 — THERATRON EQUINOX, MODELS 80 CM AND 100 CM
- K053488 — CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM
- K053553 — NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL
- K053645 — MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS
- K060023 — ANGIODYNAMICS TOTAL ABSCESSION BILIARY DRAINAGE CATHETER
- K060035 — MDXNET
- K060092 — QUICKCAT EXTRACTION CATHETER
- K060214 — BD PHOENIX AUTOMATED MIRCROBIOLOGY SYSTEM TETRACYCLINE-GN 0.5-16 UG/ML AND GP 0.5-16 UG/ML
- K060266 — DIMENSION IRON CALIBRATOR
- K060338 — FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO
- K060371 — THE EMIT 2000 TACROLIMUS CALIBRATORS
- K060378 — VITREA2 VERSION 3.8.1
- K060422 — LYSUS INFUSION SYSTEM
- K060426 — LIBERTY GLUCOSE NORMAL CONTROL SOLUTIONS, MODEL 2120041
- K060453 — AZE VIRTUALPLACE
- K060481 — LIBERTY GLUCOSE CONTROL SOLUTION
- K050709 — RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367
- K051047 — COLLOSS E BONE VOID FILLER
- K052637 — THEROX INFUSION CATHETER, MODEL INCA-1
- K052989 — DP240 240 HOUR DOPPLER PROBE
- K053217 — CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148
- K053251 — TECHDEVICE GUIDEWIRE
- K053573 — GSS PEDICLE SCREW SYSTEM
- K060057 — PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM
- K060068 — AVANTICARE, MODEL SA4021
- K060077 — RTT DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL RTW-8010A
- K060146 — ACTIVECARE ++ SYSTEM
- K060251 — WH CONVERTIBLE LIGHTWEGHT WHEELCHAIR, MODEL WHL100
- K060264 — DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)
- K060337 — BELIMED STEAM STERILIZER TOP 5000, MODEL 5-5-9
- K052202 — AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM
- K052800 — PROVISIONAL INLAY/ONLAY KIT
- K053442 — BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE
- K053463 — AIM ACCURACY IN MARKING SYSTEM
- K060103 — ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS
- K060181 — COMPE1 1 -PLY SURGICAL GOWNS
- K060212 — MERITS MODEL E SERIES LIFT CHAIRS
- K060428 — CSS CANNULATED SCREW SYSTEM
- K051617 — NOVABONE PUTTY - RESORBABLE BONE VOID FILLER
- K052953 — NUVANCE* FACIAL REJUVENATION SYSTEM
- K053319 — ALLOMATRIX CUSTOM
- K053454 — RX HERCULINK ELITE BILIARY STENT SYSTEM
- K053567 — ATHROCARE TOPAZ ARTHROWANDS
- K060009 — ABBOTT SPINE UNIVERSAL CLAMP SYSTEM
- K060224 — MODIFICATION TO MIRA-FLEX 18 MICROCATHETER
- K060361 — XIA SPINAL SYSTEM, XIA 4.5 SPINAL SYSTEM
- K060379 — EBI ANTERIOR CERVICAL PLATE SYSTEM
- K053019 — ACUITY STEERABLE STYLET ACCESSORY
- K053430 — TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER
- K053450 — ATLANTIS ABUTMENT FOR ZIMMER INTERFACE
- K053475 — OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450
- K053531 — DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR
- K053564 — KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454
- K053580 — DOCTOR'S NIGHTGUARD
- K060086 — FENIIIIIIX COLORATION KIT
- K060277 — BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
- K060292 — KODAK MODELS 2100 AND 2200
- K050975 — NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN
- K051907 — INNOCOR
- K052623 — IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM
- K052881 — VYGON LATEX FREE BIONECTOR
- K053012 — FIDIS VASCULITIS, MODEL MX007
- K060069 — PALOMAR LUXIR FRACTIONAL HANDPIECE
- K060209 — AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEM
- K060399 — LC SPRINT NEBULIZER
- K051640 — U2 TOTAL KNEE SYSTEM
- K053039 — CLINTON ELECTRONICS SERIES II DIGITAL GRAYSCALE MONITORS, MODELS DL2000, DL3000, DL2000 OF AND DL3000 OF
- K053087 — VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM
- K053138 — MYSET PREGNANCY TEST
- K053312 — EASYMATE BLOOD GLUCOSE MONITORING SYSTEM
- K053619 — COLORBITE
- K053640 — INTEGRA
- K060061 — STRYKER INJECTABLE CEMENT
- K060420 — MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002
- K050828 — TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM
- K052450 — KD-788 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.