FDA 510(k) clearances — page 635
clearances on record, most recent first.
Clearances — page 635
63,401–63,500 of 175,825- K052731 — KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUPUNCTURE NEEDLES
- K052991 — RADIANCY FACIAL SKINCARE DEVICE
- K053103 — INTERFACE
- K053170 — PREFORMANCE POSTS
- K053178 — SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS
- K053403 — LUCAS
- K053421 — YAG MIR FAMILY LASER
- K053443 — BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE
- K050952 — HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR
- K051163 — GALIX ECG PROFESSIONAL STATION
- K051648 — SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS
- K052438 — EMG HANDLE NEBULIZER NB02 SERIES
- K052930 — NAVIGATOR ENDOSCOPY SYSTEM
- K053028 — TECHDEVICE GUIDEWIRE
- K053112 — BIOSIGN
- K053156 — MINI-WRIGHT DIGITAL, MODEL 3120001
- K053177 — MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E
- K053226 — ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEMS WITH FENESTRATED CATHETER AND FLOW SPLITTER
- K053228 — THERIGRAFT TCP PUTTY BONE VOID FILLER
- K060006 — BRAUN THERMOSCAN IRT 2000 INFRARED EAR THERMOMETER
- K060031 — DEPUY MODULAR M HEADS
- K060078 — FIBERED IDC OCCLUSION SYSTEM
- K060136 — PLANAR DOME EX SERIES DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL E4C COLOR
- K052654 — KLOCKNER DENTAL IMPLANT, MODEL S3M
- K053124 — BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES
- K053176 — DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797
- K053208 — CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISION TRIAL TRANSFER CATHETER SET
- K053548 — MODIFIED PVA-PLUS FOAM EMBOLIZATION PARTICLES AND MAXISTAT AND MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
- K053631 — CONTOUR TRANSTAR CURVED CUTTER STAPLER SET
- K051028 — BREEZE
- K052534 — TACAHE
- K052649 — DRG SLV TESTOSTERONE ELISA TEST
- K052915 — PROFEMUR XTR HIP STEM
- K052918 — REPROCESSED EXTERNAL FIXATION DEVICES
- K052951 — ENDOPORE ANATOMIC ENDOSSEOUS DENTAL IMPLANT SYSTEM
- K052959 — DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS
- K053086 — MIE - GAMMA CAMERA SYSTEMS
- K053091 — PROCERA IMPLANT BRIDGE ZIRCONIA
- K053270 — IVENT 201
- K053311 — STRYKER SCOPE WARMER
- K042096 — MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM
- K051447 — SENTINEL PANCREATIC AMYLASE
- K052442 — RADIANCY SKINSTATION WITH PSORIASIS LIGHT UNIT ASSEMBLY
- K052479 — MBATH 1000 (60)
- K053021 — ESTECH CLEARVIEW MV ATRIAL DEPRESSOR
- K053198 — SIMPLEX P SPEEDSET BONE CEMENT
- K053327 — OXICOM CONTROL
- K053338 — ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS
- K053514 — TRIATHLON TOTAL KNEE SYSTEM
- K053516 — MUCOHARD
- K053518 — INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
- K053630 — LEVITRONIX CENTRIMAG PRIMARY CONSOLE
- K053642 — OSTEOSET DBM PELLETS
- K060026 — KOBY SURGICAL INTERNAL FIXATION SYSTEM
- K060027 — ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)
- K060071 — NEXA COMPRESSION SCREW
- K052666 — NON-STERILE POWDER FREE NATURAL/GREEN LANO-E LATEX EXAM GLOVES, WITH OR WIHOUT CITRUS/PEPPERMINT SCENT PLUS A PROTEIN
- K052812 — OSSIMEND (TM) BONE GRAFT MATERIAL
- K052813 — FD TENS 2030, MODEL DFJ24T
- K053180 — PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS
- K053274 — ANATOMICAL SHOULDER INVERSE/REVERSE
- K053328 — BIOSPLINT SPLINTING RIBBON
- K053379 — RELI-ON ONE STEP, ORTHODONTIC ADHESIVE
- K053455 — ENCOMPASS.NET
- K053574 — MEDLINE PEDIATRIC WHEELCHAIRS
- K052577 — IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM
- K052773 — B. BRAUN 0.2 MICRON FILTER
- K053044 — OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5
- K053185 — PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM
- K053235 — NSK PRECISION APEX LOCATOR (PAL)
- K053309 — ALTAIRE INTERVENTIONAL MR PACKAGE
- K053606 — BE PLUS / AURA-LTM64 AMPLIFIER
- K053641 — IBA PROTON THERAPY SYSTEM-PROTEUS 235
- K053648 — PIONEER TC8080, COMPANION III
- K060087 — ACCUVIX V7 DIAGNOSTIC ULTRASOUND SYSTEM
- K060096 — MODULAR TROCAR SYSTEM
- K050955 — LIFESIGN DXPRESS, MODEL LSR2000
- K051677 — OPTIGEN ALLERGEN SPECIFIC IGE ASSAY
- K052680 — CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES
- K052762 — LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067
- K052789 — TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200
- K052878 — NT-1000
- K052997 — ZIMMER DENTAL ONE-PIECE IMPLANT
- K053022 — SYNTHES (USA) CHRONOS-BETA-TCP
- K053643 — STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026
- K060050 — MEGABEAM SIDEFIBER FIBER OPTIC DELIVERY SYSTEM
- K051400 — DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO5 AND L-ANEO5A SOFTWARE, USING F-CU8 OR F-CU5(P) MONITOR FRAME OPTIONS
- K051774 — MBCP
- K052822 — DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 100, 101, 200, 201 AND 202
- K052825 — VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG
- K052854 — LIFENET EXCHANGE SYSTEM
- K052975 — DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND DATEX-OHMEDA S/5 CELLULAR VIEWER WITH L-WEB04 SOFTWARE
- K053243 — SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
- K053332 — BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500
- K053557 — ESKA-LIBUR HIP STEM
- K053559 — PF4 ENHANCED SOLID PHASE ELISA
- K060001 — D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM
- K060020 — AUTOQUANT PLUS
- K060058 — STELLAR 404T
- K042504 — CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.