FDA 510(k) clearances — page 522
clearances on record, most recent first.
Clearances — page 522
52,101–52,200 of 176,542- K093072 — STARCARE HANDPIECE MAINTENANCE UNIT
- K090959 — LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA
- K093035 — FORA V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244
- K093250 — PROTON THERAPY MULTILEAF COLLIMATOR
- K093393 — LIFEDOP MODEL 300ABI
- K093551 — PARADIS VASO SHIELD
- K090534 — VENOUS HARDSHELL CARDIOTOMY RESERVIORS
- K090555 — PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30
- K090690 — VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING
- K090819 — ONTEX TAMPON (UNSCENTED)
- K090820 — TRIA HAIR REMOVAL LASER SYSTEM
- K090832 — RAPID-I
- K091265 — ZOLL E SERIES WITH CPRREADYCHARGE
- K091426 — CERVICORE CORPECTOMY CAGE
- K091579 — FORESEE HOME
- K091644 — SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATES
- K091729 — ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE
- K091749 — U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS
- K092371 — SWIFT-LOCK ANCHOR, MODEL 1192
- K092438 — ZIEHM SOLO
- K092469 — O-SCAN MR SYSTEM
- K092510 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7901, KD-7905, KD-7911
- K092803 — CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENT
- K092837 — OTI-SCAN 3000
- K092998 — CONMED LINVATEC INTERCEPT IMPLANT
- K093077 — ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
- K093098 — AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM
- K093242 — PATRIOT TRANSCONTINENTAL LLIF SPACER
- K093391 — SIMUPLAN TREATMENT PLANNING SYSTEM
- K093415 — D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT
- K093452 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-571, KD-7971
- K093613 — VASCUVIEW TAP ULTRASOUND SYSTEM
- K093616 — V. MUELLER CAMERA CONTROLLER WITH STORAGE CART
- K093636 — STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL H74939334XXXXXXX
- K093663 — RADIONUCLIDE BRACHYTHERAPY SOURCE
- K093675 — INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076
- K093704 — AVS PL PEEK SPACERS
- K093720 — STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL OVER-THE-WIRE BALLOON DILATATION CATHETERS MODEL VARIO
- K091701 — STRAUMANN MODIFIED DENTAL ABUTMENT
- K091762 — DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE
- K091926 — CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM
- K092170 — STA LIATEST FREE PS
- K092186 — VPAP TX
- K092796 — IBA PROTON THERAPY SYSTEM, PROTEUS 235
- K092904 — PATHWAY IVB/VBR
- K093019 — ENAMELITE ACRYSEAL SPRAY SEALANT
- K093025 — BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODES
- K093167 — STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
- K093439 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K093483 — ATLANTIS ABUTMENT FOR NOBEL BIOCARE ACTIVE IMPLANT, ATLANTIS GEMINI ABUTMENT, GEMINI + ABUTMENT
- K090435 — VERTECEM
- K091543 — LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS
- K090515 — ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)
- K090518 — QUART ARTERIAL FILTER WITH SOFTLINE COATING
- K090533 — HLM TUBING SET WITH SOFTLINE COATING
- K090806 — SAFI-GEL DAILY DISPOSABLE (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, SAFI-GEL DAILY DISPOSABLE TORIC ( METHAFILCON
- K090921 — ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02
- K091045 — SMART TENS, MODEL: D-BC05T
- K092044 — ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE
- K092483 — BARD PERMAFIX FIXATION SYSTEM, MODEL 0113012, 0113014, 0113016, 0116018
- K092488 — DYNAREX STERILE LUBRICATING JELLY
- K092546 — GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM
- K092648 — RESPIRONICS PERFORMAX SE TOTAL FACE MASK
- K092788 — PERIOPHIL BIPHASIC
- K092823 — AMSCO WARMING CABINET
- K092883 — LED LAMP OR OTHER
- K092910 — FLUID-FILLED TEETHER
- K093001 — STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER
- K093050 — ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520
- K093113 — ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENT
- K093177 — INTELLIBRIDGE SYSTEM
- K093557 — SMARTWAND-DTX
- K093601 — AF 840 PH.I.S.I.O. ARTERIAL FILTER
- K093644 — RESTORATION ADM SYSTEM X3 ACETABULAR
- K083174 — HEALTHEPOD
- K092264 — ATLANTIS HYPERBARIC CHAMBER VENTILATOR
- K092344 — LAC-MAC INNERBLOC LR SURGICAL GOWNS
- K092557 — DIGITAL THERMOMETER,HMCDT-002/KINETIK BRANDED DT1 SERIES
- K092953 — Xpert VanA Assay
- K093090 — GALILEOS IMPLANT, VERSION 1.7
- K093252 — FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER
- K093259 — ARP RX100
- K093397 — TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE
- K093428 — SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR
- K093546 — SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX
- K093646 — DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS
- K090964 — BINAXNOX STAPHYLOCOCCUS AUREUS TEST
- K090993 — INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS3000
- K091034 — AQUACEL AG SURGICAL
- K091118 — FOOT AND HAND MOTION SYSTEM
- K091361 — IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM
- K092169 — ELECSYS PROBNP II CALCHECK 5
- K092236 — E.COLI/P. AERUGINOSA PNA FISH
- K092445 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
- K092912 — STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150
- K092928 — DOSE VOLUME HISTOGRAM (DVH) EVALUATOR
- K093084 — ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP
- K093144 — LOUSEBUSTER
- K093260 — AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM
- K093513 — IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.