FDA 510(k) clearances — page 809
clearances on record, most recent first.
Clearances — page 809
80,801–80,900 of 175,825- K001896 — KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH EC
- K002603 — ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER
- K002717 — STERILE PISTON SYRINGE
- K002915 — FLEXIBLE OCCLUSION SYSTEM
- K003151 — MICROPOBE SERIES OF LASERS AND ACCESSORIES
- K003164 — TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM
- K003227 — BIO-ABSORBABLE CORKSCREW MODEL AR-1920B
- K003334 — STICK NET
- K003339 — COLLAGEN PERIODONTAL MEMBRANE
- K003822 — ISOLA CLOSED DUAL ROD CONNECTOR
- K003827 — PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION
- K003925 — PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS
- K990800 — INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS
- K003136 — OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT CONTACT LENS
- K002488 — KELO-COTE TOPICAL GEL
- K003031 — LENSOCLEAN MULTI-PURPOSE SOLUTION, MODEL 355ML
- K003154 — MIZAR, BASIS BE, SANDMAN DIGITAL
- K003289 — BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED); BARDEX LUBRI-SIL TEMPERATURE-SENSING FOLEY CATHETER (LU
- K003292 — 260 CORVUS
- K003763 — 2010 PLUS HOLTER FOR WINDOWS
- K003768 — MONARCH II IOL DELIVERY SYSTEM
- K003793 — BARD LUMINEXX BILIARY STENT
- K003956 — BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595
- K002269 — ELECTROSURGICAL PROBES AND DEVICES-GELTX
- K002513 — ASTRA TECH IMPLANTS - DENTAL SYSTEM
- K002863 — PALFIQUE ESTELITE LV
- K002932 — PHACOGARD
- K003111 — STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES
- K003127 — REGAIN DESKTOP
- K003155 — VERTEBRAL BODY REPLACEMENT
- K003176 — BIOEMG II AND BIOJVA
- K003269 — UNICONDYLAR INTERPOSITIONAL SPACER
- K003330 — AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC)
- K003333 — STICK
- K003367 — ORION PLATINUM
- K003462 — ERBE APC HANDLE AND APPLICATORS, MODEL 20132-043,20132-031,20132-032,20132-033,20132-034,20132-040,20132-044,20132-045
- K003498 — FRESENIUS OPTIFLUX 200A
- K003658 — TEMP-BOND NE 2
- K003753 — GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE
- K003832 — SULZER ORTHOPEDICS ANATOMICAL SHOULDER CEMENTED HUMERAL STEM
- K003898 — EBI VUECATH SPINAL ENDOSCOPIC SYSTEM
- K003415 — ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE
- K003729 — ULTIMUM EV HEMOSTASIS INTRODUCER (14F), ULTIMUM EV HEMOSTASIS INTRODUCER (16F), ULTIMUM EV HEMOSTASIS INTRODUCER (18F),
- K003756 — BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES
- K003441 — CASTLE MODEL 233HC STEAM STERILIZER
- K003451 — DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T
- K003509 — FLEXICAST
- K003563 — POWDER-FREE NITRILE EXAM GLOVE, LAVENDER/PURPLE
- K003764 — MODIFICATION TO EBI SPINELINK SYSTEM
- K994292 — WATER PURIFICATION SYSTEM
- K002127 — INJECTRITE-C15 AND INJECTRITE-C30
- K002182 — AVITA TSO/TS1 INFRARED EAR THERMOMETER
- K003240 — BIOMET EXTERNAL WRIST PLATE
- K992424 — SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGTH), MODELS 63244J20 & 63246J20
- K001576 — EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY
- K003040 — INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
- K003097 — BRAIN COIL, MODEL 9800GE-64
- K003212 — FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
- K003386 — SPECIAL PROCEDURES HEAD COIL; MODEL # 1100GE-64
- K000396 — APNOESCREEN PRO, ALPHA SCREEN PRO
- K001499 — PHORMAX EAGLE SCANNER SYSTEM
- K001738 — DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
- K001785 — SURGISIS PERIPHERAL VASCULAR PATCH
- K002031 — PHACOFRAGMENTATION SYSTEM MEGATRON
- K002197 — CARTOUCH
- K002803 — THE O'NEIL STERILE FIELD URINARY CATHETER KIT
- K002830 — PELVIC MUSCLE THERAPY
- K003175 — COMPUMEDICS SIESTA SYSTEM
- K003215 — MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
- K003230 — V SCORE WITH AUTO GATE MODEL TBD
- K003516 — GYROSCAN INTERA 3.0T
- K003568 — XISCAN 6000 IMAGING SYSTEM
- K003643 — NUMED Z-MED PTV CATHERERS
- K003739 — ALOKA SSD-4000
- K003815 — TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER
- K003050 — CRYOSURGICAL UNIT AND ACCESSORIES
- K003372 — IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP
- K003677 — ABX PENTRA 60C+ HEMATOLOGY ANALYZER
- K000641 — CD HORIZON SPINAL SYSTEM
- K001955 — AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250
- K002449 — BIOTEQ I.V. (INTRAVENOUS) SET
- K002976 — RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX
- K003036 — TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025
- K003134 — FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING
- K003196 — SYNCHRON SYSTEMS AMMONIA REAGENT
- K003257 — EHC400 DESKTOP PATIENT STATION; ECH600 CARE PROVIDER STATION
- K003265 — CLEANAIR/ CLEANWATER UNIT, MODEL 1600
- K003270 — PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067
- K003305 — PEDIATRIC INGESTASCAN
- K003366 — MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL
- K003635 — DW 276 #3
- K003685 — MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL
- K003687 — VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC
- K003769 — ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES, MODEL 87
- K003790 — DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005
- K003849 — GE ADVANCE NXI PET SYSTEM
- K994279 — PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)
- K000714 — VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER BLOOD COLLECTION SET
- K001634 — CARDIOSENTRY EVENT MONITOR, MODEL 8470-01
- K002122 — VECTOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.