FDA 510(k) clearances — page 606
clearances on record, most recent first.
Clearances — page 606
60,501–60,600 of 176,637- K070052 — MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION
- K070208 — SYNTHES 4.5 MM LCP POSTEROLATERAL PROXIMAL FEMUR PLATES
- K070423 — TR BAND
- K070543 — MODIFICATION TO HEALTH BUDDY APPLIANCE
- K070712 — MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM
- K060976 — MOORLD12-B1 LASER DOPPLER BURNS IMAGER
- K063090 — MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY
- K063155 — MONARCH III IOL DELIVERY SYSTEM
- K063867 — CUTERA ER:YSGG LASER HANDPIECE
- K070138 — CUTERA ER:YAG LASER HANDPIECE
- K070232 — ECG CABLES, TRUNK AND PATIENT LEAD WIRES
- K070304 — DIGORA PCT/DIGIPOD
- K070394 — CERNER PROVISION WORKSTATION
- K070534 — MODIFICATION TO: OCU-FILM TIP COVER
- K063401 — BANANA RIBBED
- K063442 — ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR
- K063770 — ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM
- K063864 — QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS
- K070045 — ZIRBLANK-PS AND ZIRBLANK-FS
- K070169 — KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE
- K070404 — NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
- K070407 — DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE
- K070476 — REVOLIX 120
- K070576 — ACUSON X150 ULTRASOUND SYSTEM
- K070629 — FLEX AND LOOP COIL SET 1.5 T
- K061412 — THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401
- K062033 — BP 101 DIGITAL BLOOD PRESSURE MONITOR
- K063005 — STRYKER T6 HOODS AND TOGAS
- K063044 — CARDIOBELT ELECTRODE BELT
- K063293 — EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE
- K063324 — PET VCAR
- K063356 — STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK
- K063804 — OLYMPUS TRIGLYCERIDE TEST SYSTEM
- K070038 — POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW
- K070097 — POWDER FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR
- K070142 — SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20
- K070204 — LINK TO ACUITY CLINICIAN NOTIFIER
- K070205 — ZIOSTATION
- K070468 — IMPLANT SCIENCES CORP. MODEL HDR 4454
- K070493 — HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, P17RT
- K070526 — DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
- K070542 — CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS
- K070545 — K-Y BRAND WARMING LIQUID
- K062014 — FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB
- K062282 — MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRARY, VERSION 3.0
- K062720 — S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES
- K063430 — ZERO PROFILE ANTERIOR CERVICAL PLATE (ACP) SYSTEM
- K063568 — HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL
- K063599 — PORTI 7 PHYSIOLOGICAL AMPLIFIER
- K070027 — POWDERED (WHITE) VINYL PATIENT EXAMINATION
- K070134 — MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098
- K070306 — PAINT- ON POLISH AGENT
- K070485 — BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58L
- K070501 — RUIKE 3421 POWERED WHEELCHAIR
- K070509 — FISSO HOLDING SYSTEM
- K062258 — GENESIS DIODE LASER
- K062547 — QUADRA BLOC TENS, MODEL 101
- K063043 — SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP
- K063128 — ADVANCE SPIKED POROUS TIBIAL BASE
- K063186 — ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM
- K063209 — HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL
- K063663 — DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H
- K070039 — MEMOMETAL FIXOS SCREWS
- K070073 — ALIGN URETHRAL SUPPORT SYSTEM
- K070100 — HASELMEIER PEN
- K070213 — PERFORMER CBP SYSTEM
- K070325 — CLEARFIL MAJESTY ESTHETIC PLT
- K062308 — LMT-KATH-S; LMT-KATH-I
- K062873 — SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS
- K062919 — TEXTURED POWDER FREE NITRILE EXAM GLOVES (PEACH)
- K063347 — AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10
- K063403 — CONICAL ANGLED ABUTMENT
- K063444 — TOTAL ETCH BONDING AGENT
- K063556 — PERIPATCH ENDO-SLEEVE
- K063627 — POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
- K063863 — ADVANTAGE CUFF, NON-INVASIVE BLOOD PRESSURE HOSE AND ADAPTER
- K070011 — IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER
- K070391 — ELECSYS PTH TEST SYSTEM
- K070482 — ISIS
- K070532 — SPIROS
- K070588 — PHILIPS SURESIGNS VSV (VITAL SIGNS VIEWER)
- K070603 — C.T.M. MOBILITTY SCOOTER # HS-295
- K060648 — REPROCESSED PHACOEMULSIFICATION TIPS
- K061504 — POWDER FREE NITRILE BLUE EXAMINATION GLOVE
- K062621 — NIO 5MP-21 AND MDNG-5121 CB
- K063150 — COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL
- K063756 — DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE
- K063866 — BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
- K070031 — MEMOMETAL MEMORY STAPLES
- K070033 — MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-10
- K070188 — POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW
- K070200 — TDM CONTROL SET, MODEL CAT# 04521536
- K070342 — CLINICAL ELECTRONIC THERMOMETER, MODELS TP11403 THROUGH TP11413
- K070420 — BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138
- K984204 — SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP
- K984205 — SILVERLON ADHESIVE STRIP
- K984207 — SILVERLON DIRECT PRESSURE WOUND DRESSING
- DEN070004 — XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065
- K061489 — ATRILAZE MI SURGICAL ABLATION SYSTEM
- K062306 — PLASMACON N, PLASMACON L-1, PLASMACON L-2
Data sourced from openFDA. This site is unofficial and independent of the FDA.