FDA 510(k) clearances — page 703
clearances on record, most recent first.
Clearances — page 703
70,201–70,300 of 175,825- K033360 — DIAZYME LITHIUM ENZYMATIC ASSAY KIT
- K033383 — TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200
- K033541 — LONG LOVE CONDOM
- K033695 — IRRIGATION CHANNEL TUBING, MODEL 100135
- K033712 — MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1
- K033832 — SYNGO PERFUSION-CT
- K033847 — A1CNOW FOR HOME AND PROFESSIONAL USE
- K030767 — FIDJI SMALL CEMENT RESTRICTOR
- K030871 — FIDJI LARGE CEMENT RESTRICTOR
- K031968 — CERABIEN ZR
- K032925 — B&R DEVICE
- K033192 — RH-950
- K033267 — EPRICORD
- K033308 — VINYL EXAMINATION GLOVES, POWDERED
- K033394 — CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM
- K033528 — MESACUP-2 TEST JO-1, MODEL 10756
- K033629 — VERSYO.BOND
- K033799 — CLINICAL LASETTE P-200
- K030713 — BAY AREA HYPERSCIENCES
- K031260 — FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005
- K031373 — IXL DIABETES MANAGEMENT SYSTEM
- K031436 — MEDISCOPE
- K031579 — INSTAREAD LITHIUM SYSTEM
- K031831 — TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM
- K031947 — BAYER CLINITEK STATUS ANALYZER
- K032219 — REVOLUTION SPINAL FIXATION SYSTEM
- K032251 — IMMUNETECH TOTAL IGE SYSTEM
- K032288 — VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL
- K032663 — QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2
- K032763 — VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER
- K032887 — PHENOL RED STOCK SOLUTION
- K032893 — SHELHIGH NO-REACT BIOCUFF
- K032928 — MEDIPHYSICS PAIN TREATMENT SYSTEM, MODEL 1
- K032944 — YA-MAN LASER 21
- K032950 — GEM INSET PATELLAR COMPONENT
- K033020 — IMPAK ACRYLIC REPAIR RESIN LIQUID
- K033076 — LIFESTYLES LIQUID PERSONAL LUBRICANT
- K033084 — WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER
- K033094 — ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT)
- K033159 — LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05
- K033203 — WILSON-COOK TRI-TOME SELECT PLUS
- K033280 — DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM
- K033287 — EXACTRAC GATING
- K033359 — DEGALL II GALLBLADDER EXTRACTOR
- K033379 — BAYER SPECIAL CHEMISTRY CONTROLS
- K033558 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS
- K033603 — INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999
- K033657 — MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V
- K033691 — SAFYRE VS AND SAFYRE T
- K033758 — HYDROPHILIC GUIDEWIRE
- K033782 — ALLEGRO IMAGING SYSTEM
- K033795 — PLASMACURE BXE
- K033831 — SIENET COSMOS
- K033857 — T-TECH DIGITAL, MODEL WL-22XXA SERIES
- K033867 — GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS
- K031618 — COMFORT VARIOUS OF STANDING WHEELCHAIR, HERO 2
- K031711 — TANGO, MODELS, BP1
- K031804 — COMPRESS DISTAL FEMORAL REPLACEMENT
- K032029 — BTG SMARTEST GLUCOSE TEST SYSTEM
- K032973 — REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS
- K032980 — AMI REPROCESSED MULTIPLE CLIP APPLIERS
- K033161 — VISU-LOCK 5MM CLIP APPLIER
- K033206 — EPW FOLDABLE POWER WHEELCHAIR, EPW-03
- K033220 — BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S280
- K033240 — BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S200
- K033524 — COAPT ENDOTINE CHIN 3.5 DEVICE
- K033612 — FACTOR II (PROTHROMBIN) G20210A KIT
- K033672 — MODIFICATION TO UNITY NETWORK ID
- K033709 — VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE
- K033746 — MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE
- K033763 — MODIFICATION TO SLIM GLIDING NAIL SYSTEM
- K033827 — UB 140
- DEN030005 — FACTOR V LEIDEN KIT
- K030086 — PALACOS R BONE CEMENT WITH GENTAMICIN
- K031560 — BAYER RAPIDLAB 1200 SYSTEM
- K032358 — B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM)
- K032779 — MODIFICATION TO: NUCAMMA RX
- K032942 — PROFEEL POWDER FREE, PLOYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE
- K032943 — STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS
- K033040 — PHOENIX INFANT RADIANT WARMER, MODEL 100NWS
- K033052 — CONDUCTIVE EEG ELECTROLYTE
- K033229 — (MULTIPLE LABELS) POWDER-FREE VINYL EXAMINATION GLOVES
- K033235 — GEMINI III HYBRID TX/RX 4 CHANNEL HEAD COIL
- K033637 — MEDICAL IMAGE DIGITIZER, MODEL 2908
- K033653 — VENTURI PHACO PACK
- K033664 — MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM
- K033666 — HEMADERM
- K033682 — SET GRI-FILL 2.0-1 WAY; 2.0-2 WAYS; LUER CONNECTION TUBE
- K033698 — CONTOUR-FLEX VALVE AND SHUNT SYSTEM
- K033734 — LIGHTCYCLER INSTRUMENT VERSION 1.2
- K033753 — PELVIC ARRAY COIL
- K032424 — LOTUS
- K032469 — AESKULISA ANA 8PRO
- K032741 — EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION
- K032909 — THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM
- K032920 — THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003
- K032994 — GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING)
- K033054 — HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP
- K033380 — BAYER SPECIAL CHEMISTRY CALIBRATORS
- K033551 — EVOLVE
Data sourced from openFDA. This site is unofficial and independent of the FDA.