FDA 510(k) clearances — page 574
clearances on record, most recent first.
Clearances — page 574
57,301–57,400 of 176,542- K080688 — C-QUR LITE MESH V-PATCH
- K080691 — C-QUR EDGE MESH V-PATCH
- K080736 — ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE
- K080929 — ONCENTRA GYN
- K062691 — COMPORUS
- K070570 — DIO IMPLANT SYSTEM
- K072614 — MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE
- K070889 — AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112
- K072201 — COMPUMEDICS SOMTE PSG RECORDING SYSTEM
- K072598 — IRSG I-MOVER FOR BEDS
- K073497 — HDL CHOLESTEROL REAGENT, MODEL 10211
- K080039 — PASSIVE WASTE GAS SCAVENGER, MODEL 14600
- K080308 — BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD
- K080373 — TACAHE PC1350 POWER WHEELCHAIR
- K072460 — HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
- K072720 — ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM
- K073058 — RESCUE INTERNAL IMPLANT SYSTEM
- K073106 — UNIFAST III
- K073376 — PHILIPS ECG ALGORITHM
- K073520 — ANGIOTECH CVC
- K073710 — INTOUCH REMOTE PRESENCE ROBOTIC SYSTEM, MODEL RP-7
- K073716 — LIFE+CEL OR LIFECEL BATTERY
- K080095 — CORAMATE/SPIROTOME SYSTEM
- K080126 — DIO PROTEM IMPLANT SYSTEM
- K080246 — COMPOSITE ALIGNER BUTTON
- K080261 — IMPULSE IQ ADJUSTING INSTRUMENT
- K080624 — NAVSTATIONIRAD EMT, VERSION 1.1
- K080768 — ULTRATEMP FIRM, FAST AND REGULAR SET
- K080882 — CEREC OPTI SPRAY
- K080884 — QHRV 1 - HEALTH ASSESSMENT SYSTEM
- K080927 — BRIGHTVIEW VCT IMAGING SYSTEM
- K060387 — PHYSIOFLOW SYSTEM
- K070587 — ELEGANCE WOMAN'S LUBRICANT
- K071524 — TCMNATURELMED, HEALTHCARE, BLOODCARE, BO'S ABDOMINAL
- K072041 — BOVIE IDS-400 ELECTROSURGICAL GENERATOR
- K072458 — GBI TSH NEONATAL SCREENING KIT
- K073219 — WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08
- K073590 — KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT
- K073648 — GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1
- K080083 — INTREPID SPINAL SYSTEM
- K080163 — COOLTOUCH MODELS LC215 AND COOLLIPO
- K080185 — AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM
- K080363 — BAHA CORDELLE II
- K080434 — INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW
- K080850 — DARCO HEADLESS COMPRESSION SCREW
- K080857 — CHROMOPHARE E-SERIES
- K073222 — MODIFICATION TO:SPECIALTY NEEDLES
- K073617 — PHARAON LIPO
- K073695 — 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17
- K080099 — PASS SPINAL SYSTEM
- K080132 — THD DISPOSABLE ANOSCOPE/PROCTOSCOPE
- K080226 — NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912
- K080410 — KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522
- K080770 — IMAGENMD WITH IMAGENQ
- K080880 — RTM AND OVAL
- K080917 — IROOT SP
- K072302 — ENTELLUS MEDICAL RS-SERIES SYSTEM
- K073365 — DENTAL DIGITAL X-RAY IMAGING SYSTEM
- K073492 — DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEM
- K073571 — TRICOS T RESORBABLE BONE SUBSTITUTE
- K073696 — VERAVIEWEPOCS
- K080079 — S8 ESCAPE II
- K080182 — ZENO PMMA DISC
- K080300 — CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)
- K080325 — IGROK
- K080360 — ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER
- K080502 — MODIFICATION TO:PILOT SPINAL SYSTEM
- K080663 — PROFEMUR LX REVISION 5/8 COATED HIP STEM
- K080792 — K2M COCR ROD
- K072414 — CRYOSTAT
- K072885 — CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110
- K073143 — MODIFIED VERTIFLEX SPINAL SCREW SYSTEM
- K073465 — US/GS ULTRA WIDE SYSTEM
- K080305 — NEXCOMP AND META ETCHANT
- K080572 — LDR SPINE ROI-A IMPLANT
- K080697 — SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER
- K080800 — ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM
- K063437 — ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300
- K070217 — INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE
- K071483 — TETRIX CREAM
- K072032 — IGG ANTI-ATHEROX TEST KIT
- K072170 — WELLGRAFT PE II
- K072444 — WELLGRAFT PE I
- K072583 — PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30
- K073364 — EXPEDIUM 4.5MM SPINE SYSTEM
- K073458 — BT-TITE ONE(BTICV1), BT-TITE STANDARD(BTIVSM), BT-TITE CV2(BTICV2)
- K073486 — DENTIS DENTAL IMPLANT SYSTEM
- K080043 — VIZILITE EYEWEAR
- K080060 — VIVOSONIC NEUROSCREEN
- K080438 — DENTAL UNIT WITH CHAIR
- K080565 — MODIFICATION TO: SAVI APPLICATOR KIT
- K080681 — KOWA GENESIS-D
- K080735 — CRYOMINI
- K080806 — ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608
- K080827 — HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810
- K073132 — MODEL D DISC FORCE
- K073483 — SAPPHIRE O/E ORAL EXAMINATION SYSTEM
- K073534 — CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS
- K080042 — SPIRUS MEDICAL SURGICAL INSTRUMENT
- K080192 — HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS)
Data sourced from openFDA. This site is unofficial and independent of the FDA.