FDA 510(k) clearances — page 635
clearances on record, most recent first.
Clearances — page 635
63,401–63,500 of 176,637- K060957 — MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM
- K060974 — RELIENT NAVIGATION DEVICE
- K052371 — DEPILITE EL-8B SERIES DERMO FLASH SYSTEMS
- K052392 — HOT DOG PATIENT WARMING SYSTEM
- K053111 — STA-CEPHASCREEN KIT
- K053188 — REPROCESSED BALOON INFLATION DEVICE
- K053234 — PM-9000 EXPRESS PATIENT MONITOR
- K053546 — SONICATOR 740, MODEL ME 740
- K060065 — CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR
- K060129 — IGS VAGINAL SPECULUM
- K060271 — SPIRALOK ANCHOR
- K060295 — CARBON DIOXIDE
- K060369 — STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK
- K060549 — AUTOMOBILE LIGHTER POWER CORD
- K060553 — RC LOOP /DUAL ORTHOCORD SUTURE,RC LOOP W/ETHIBOND SUTURE,RC LOOP W/PANACRYL SUTURE
- K060671 — KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS
- K060884 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K060886 — POWDERED VINYL PATIENT EXAMINATION GLOVES
- K060930 — INSURE II
- K060949 — DP-6600 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
- K060956 — G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004
- K061091 — BABYBEAT CORDLESS
- K052639 — GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER
- K052771 — SENSOR WALK
- K060275 — PIEZOTOME
- K060287 — DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM
- K060353 — ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000
- K060574 — TOTAL BILIRUBIN
- K060585 — ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH
- K060742 — LEGION COBALT CHROME REVISION KNEE SYSTEM
- K060867 — SPY INTRAOPERATIVE IMAGING SYSTEM
- K060993 — GE LOGIQ P5 AND A5
- K061068 — EG-3670URK
- K061104 — SPEECHLINK 100 TYPE 1053
- K052824 — KIMBERLY-CLARK PROCEDURE GOWN
- K053052 — MEDELA SWING BREAST PUMP
- K053333 — EAGLEVISION GELLANSERTS, MODEL REF 0040
- K060273 — SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 53837
- K060380 — FIDIS DSDNA
- K060554 — CMA CEREBRAL TISSUE MONITORING SYSTEM
- K060799 — COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA
- K060803 — G.USBAMP
- K060894 — BIFIX QM
- K060931 — HEMOSIL PT-FIBRINOGEN HS PLUS
- K061009 — PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS
- K052708 — PYLO-PLUS
- K060073 — TEXTURED POWDER FREE NITRILE EXAM GLOVES (BLACK COLOR), CHEMO LABELING
- K060274 — PIEZOTOME
- K060633 — COHERENCE ONCOLOGIST WORKSPACE, MODEL 2.0 AND PHYSICIST WORKSPACE, MODEL 1.0
- K060728 — NOVABONE PUTTY - BIOACTIVE SYNTHETIC GRAFT
- K060771 — POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED) AND BLUE COLORED
- K060784 — SYNTHETIC VINYL PATIENT EXAMINATION GLOVE-POWERED
- K060961 — 15-INCH (38CM) COLOR LCD MONITOR CDL1566A
- K061029 — JETSTREAM WORKSPACE
- K052996 — POROUS TITANIUM ACETABULAR SHELLS
- K053265 — MICRUS GUIDE WIRE, WATUSI 0.014
- K060093 — PRESEP OLIGON OXIMETRY CATHETERS
- K060139 — CRP-ADVANCE ASSAY, MODELS 250-20, 250-25
- K060147 — POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
- K060222 — LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP
- K060317 — ANTHOGYR CONTRA ANGLES AND HANDPIECES
- K060336 — NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002
- K060339 — KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY
- K060345 — NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS
- K060370 — NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS
- K060461 — V-505 INFA WARMER
- K060472 — PREMISE FLOWABLE
- K060567 — SPECTRAGENICS ATS-1
- K060577 — ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS
- K060635 — CONSENSUS ACETABULAR SHELL SYSTEM
- K060654 — DSI PINS AND WIRES
- K060706 — LIBERTY NORMAL GLUCOSE CONTROL SOLUTION
- K060743 — MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM, ULTRASAFE PASSIVE DELIVERY SYSTEM (X-SERIES)
- K060761 — BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS
- K060778 — SYNTHETIC VINYL PATIENT EXAMINATION GLOVE-POWDER FREE
- K060864 — MULTIDIRECTIONAL THREADED PEG
- K060866 — PHASEAL - CLOSED SYSTEM FOR THE PREPARATION AND ADMINISTRATION OF PARENTERAL DRUGS
- K060887 — ANGIODYNAMIC, INC. MORPHEUS CT PICC AND PROCEDURE KIT
- K060904 — CLEANER ROTATIONAL THROMBECTOMY SYSTEM
- K060929 — IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6
- K060935 — SYNCHRON SYSTEMS CREATININE (CREA) REAGENT
- K060992 — SYNGO US WORKPLACE
- K061018 — PLANAR DOME EX LINE MODEL DOME E2C
- K061021 — ENTAKE STANDARD AND SAFETY PEG SYSTEM
- K051419 — INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1
- K052670 — STAXX XD SYSTEM
- K053078 — ERGOSELECT 100 K/P, ERGOSELECT 200 K/P
- K053187 — AMPLATZER NOODLEWIRE GUIDEWIRE
- K053491 — PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F
- K053535 — VIVAWAVE MICROWAVE ABLATION SYSTEM
- K060085 — STRYKER SCOPE/INSTRUMENT HOLDER
- K060089 — TULIP DISPOSABLE CANNULAS
- K060390 — SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA
- K060413 — INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE
- K060441 — VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, MODEL NX98
- K060753 — NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING, MODEL BLUE: ALL SIZES (XS-XL)
- K060877 — PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX
- K060920 — VELSCOPE
- DEN060001 — PHICAL TEST
- K052611 — ECP HEALTH SYSTEM, MODEL 2005
Data sourced from openFDA. This site is unofficial and independent of the FDA.