FDA 510(k) clearances — page 825
clearances on record, most recent first.
Clearances — page 825
82,401–82,500 of 176,637- K002125 — PINS AND WIRES
- K002179 — MAGNETOM ALLEGRA SYSTEM
- K002318 — UNITED #1018-FREEDOM SERIES, UNITED #2018-COMFORT SERIES, UNITED #3018-ELEGANCE SERIES, UNITED #5018-MASTER SERIES
- K002345 — SURGI-VISION URETHRAL COIL
- K002551 — EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL
- K002669 — EZ-LIGHT 4000 SERIES MANUAL WHEELCHAIR
- K002670 — EZ-TRAVELER 3000 SERIES MANUAL WHEELCHAIR
- K002671 — EZ-TRAVELER 2500 SERIES MANUAL WHEELCHAIR
- K002673 — EZ-COMFORT TRANSPORTER 2000 SERIES
- K002684 — COMPOSIX E/X MESH
- K002690 — MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500
- K002746 — VINYL EXAMINATION GLOVES, POWDER FREE, VANILLA COLOR
- K002876 — JOBSITE ENHANCED MOBILITY CHAIR, MODEL JEM
- K002881 — VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000
- K002897 — TITANIUM MIDDLE EAR PROSTHESES
- K002974 — EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL
- K002983 — C.T.M. POWER CHAIR, MODEL HS-5600
- K000927 — ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4
- K001719 — Q-LUX PLASMA 100 LIGHT CURE UNIT
- K002104 — COMBINED PHYSIOLOGICAL MONITORING SYSTEM
- K002140 — MENICON PROGENT REMOVER
- K002152 — TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION
- K002355 — ATOM INFA WARMER V-505
- K002496 — MODEL 4815 ADAPTER
- K002497 — MODEL 4810 ANALYZER OUTPUT ADAPTER
- K002978 — LIGTHSPEED 3.0 CT SCANNER SYSTEM
- K001519 — ACTICOAT 7 DRESSING
- K001742 — RESUSCI INFLATE-A-SHIELD CPR BARRIER
- K002082 — SPEEDLINK TRANSVERSE CONNECTOR
- K002094 — BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE
- K002110 — SPL CRIMP SYSTEM
- K002228 — PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X
- K002332 — EEG SPIKE AND EVENT DETECTOR MODULE
- K002523 — ADVANTAGE DRIVE SYSTEM
- K002557 — SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN)
- K002592 — INTERPORE CROSS ANTERIOR CERVICAL PLATE SYSTEM
- K002729 — SYNTHES PROXIMAL HUMERAL NAIL
- K002939 — MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENORS OXIMETER
- K002998 — BIOMET BI-POLAR SHOULDER SYSTEM
- K991296 — TUTOPATCH
- K000848 — TDK HANDPIECES
- K000886 — SPIROL EPIDURAL CATHETER
- K001387 — I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300
- K001603 — REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105)
- K001606 — REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107)
- K001607 — REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)
- K002069 — ASCEND SPINAL FIXATION SYSTEM
- K002137 — CATHCOR DESKTOP
- K002350 — REFACTO LABORATORY STANDARD
- K002478 — S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A08
- K002505 — XIA SPINE SYSTEM
- K002674 — RANDOX MICROALBUMIN
- K002751 — MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
- K002760 — ELECSYS DHEA-S CALSET
- K002777 — VACUETTE WITH PPACK
- K002799 — PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100
- K002802 — RAPID EXCHANGE TAPERTOME
- K002804 — N PROTEIN STANDARD SL
- K002850 — MWO-202 3D HYDRAULIC COARSE/FINE MICROMANIPULATOR
- K002857 — ELS CANNULA (KIT), MODEL M1210-88,M1510-88
- K002879 — MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
- K001125 — GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING
- K001460 — VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192
- K002057 — BROOKER TIBIA NAILS
- K002074 — AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES
- K002289 — INQWIRE DIAGNOSTIC GUIDE WIRE
- K002484 — EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL
- K002772 — ASCENT XXL CLOSED BOX FEMORAL COMPONENT
- K002962 — PRESSURE WIRE SENSOR, MODEL 12003/12303
- K001703 — PERCLOSE VASCULAR SUTURE DELIVERY DEVICE
- K002213 — BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID
- K002490 — INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER
- K002568 — POLYMER COAT, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K002836 — MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE
- K000003 — TORNIER TOTAL ELBOW PROSTHESIS
- K001464 — DISPOSABLE H-PE MICROKERATOME BLADES
- K002077 — GLUCANPRO CREAM
- K002078 — BETA GLUCAN GEL (MACROPRO GEL)
- K002294 — BIOCHECK TESTOSTERONE EIA, MODEL BC-1115
- K002296 — CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15
- K002437 — ENDIUS ENDOSCOPIC ACCESS SYSTEM
- K002732 — STRYKER NAVIGATION SYSTEM - ENT MODULE
- K001056 — OLYMPIC WARM-UP
- K002013 — OMNIPORT
- K002028 — BRAVO PH MONITORING SYSTEM
- K002451 — MODIFICATION TO: PRONTO DRY
- K002710 — MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS (LINE EXTENSION)
- K992228 — BAYER IMMUNO 1 HER-2/NEU ASSAY
- K994008 — BIOSYS FETAL MONITOR, MODEL IFM-500
- K994112 — MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)
- K001833 — PREFERENCE TREATMENT SYSTEM
- K002144 — MEDLINK DIAGNOSTIC OFFLINE WORKSTATION
- K002215 — AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA
- K002387 — COMFORT CONTROL SYRINGE SYSTEM
- K002452 — 3M RELY X VENEER CEMENT TRY-IN PASTER
- K002711 — HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER
- K002723 — REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER BANDS; REBAR MICRO CATHETER: REBAR-10 (1.7F), 170 CM, DUAL MA
- K002776 — MODIFICATION TO PROFILE -II
- K002796 — MODIFICATION TO PROVIDENT HIP SYSTEM
- K002833 — MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER
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