FDA 510(k) clearances — page 581
clearances on record, most recent first.
Clearances — page 581
58,001–58,100 of 176,542- K062970 — I-PAD
- K072420 — MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE
- K072523 — DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS
- K072736 — RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT
- K072762 — DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM
- K072770 — TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)
- K072862 — BOSTON-BAND CRANIAL REMODLING ORTHOSIS
- K072875 — NIO 5MP DISPLAY, MODEL E5620
- K073093 — DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36,
- K073424 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
- K073628 — SYNOCTA ABUTMENTS
- K080038 — VANTAGE TITAN, MODEL MRT-1504/S3
- K071631 — NICOM ELECTRODES
- K072124 — BLACK AND BLACK ELECTROSURGICAL CUTTING AND COAGULATION FORCEPS AND ELECTRODES
- K072219 — CYTOPHIL TISSUE MARKER
- K072652 — ENTERAL FEEDING SPIKE ADAPTER
- K072849 — MODIFICATION TO THERMAGE THERMACOOL SYSTEM
- K072970 — PATRIOT SPACERS
- K072991 — PATRIOT SPACERS: COLONIAL ACDF
- K073131 — MICROMRI WRIST COIL
- K073292 — MM/MMA/COLOR SERIES DIGITAL FLAT PANEL DISPLAY SYSTEM
- K073310 — OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL
- K073587 — DERMAPAL WITH DIGITAL TIMER
- K071456 — ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT
- K072635 — CLINICAL ELECTRONIC THERMOMETERS, MODEL(S) MT901, MT518, ECT-1
- K072978 — TENDER ORTHO BOND-ENA BOND-ENA ETCH
- K073101 — AURAVENEER CEMENT
- K073114 — IMIX INSIGHT X-RAY SYSTEMS
- K073395 — GILB-2, GLASS IONOMER PROTECTIVE COATING
- K073412 — GRYPHON BR AND HEALIX BR ANCHORS
- K073662 — PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS
- K080013 — REGISTRATION AND FUSION
- K063091 — PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-0601
- K071420 — CHAMELEON FIXATION SYSTEM
- K072190 — ORTHO-WRAP BIORESORBABLE SHEET
- K072662 — CHEETAH RELIANT, CHEETAH ACTIVE
- K073206 — NEEDLE-TRAP/NEEDLE SAFETY LABEL
- K073318 — BIPORE BALLOON DILATION CATHETER
- K080036 — PORTABLE ECSCOPE 12I
- K072149 — ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01
- K073090 — RECOVERY G2 FILTER SYSTEM - FEMORAL DELIVERY KIT, MODEL RF-310F; JUGULAR/SUBCLAVAIN DELIVERY KIT, MODEL RF-320J
- K073451 — PRESSURE INJECTABLE PICC
- K070511 — RICHTER MALE LATEX CONDOM
- K071104 — ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM
- K072825 — FINGERTIP PULSE OXIMETER, MODEL MD300I
- K072869 — POINTCARE NOW SYSTEM
- K072870 — MICROWAVE TISSUE COAGULATION SYSTEM (MTCS)
- K072879 — INNERVUE DIAGNOSTIC SCOPE SYSTEM
- K072917 — JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM
- K073431 — FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T
- K073433 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN (GN) -128 UG/ML
- K073473 — EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING CATHETER, MODEL 85700
- K073512 — START JUNIOR
- K073513 — MERITS E700 PORCE LIFT
- K071608 — A&J POCA01 OXYGEN CONCENTRATOR
- K071788 — AVIATOR INSULIN PUMP
- K071939 — HYDROCOIL EMBOLIC SYSTEMS (HES)
- K072385 — HEARTEVENT, MODEL AT
- K072688 — LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000
- K072790 — CONFLUENT SURGICAL EXTENDED TIP APPLICATOR, MODEL 70-2008-008
- K073038 — CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B
- K073142 — NOBELREPLACE HEXAGONAL IMPLANT
- K073190 — SLIT LAMP
- K073198 — MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP HOME (BP3MX1-1)
- K073289 — MICROSHEATH XL CATHETERS
- K073452 — MODIFICATION TO: ARAGON SURGICAL LAPCAP
- K073462 — MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES
- K073491 — EEG-1100A SWITCH BOX
- K073514 — TRANS1 AXIAL FIXATON SYSTEM
- K073630 — MODIFICATION TO: BPCARD, MODEL Z-7000-0700
- K071782 — MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES
- K072332 — VARI-LASE WIRE FIBER
- K072417 — SMITH & NEPHEW MIS HIP STEM
- K072434 — SYNTHES OC FUSION AND SYNAPSE SYSTEMS
- K072703 — PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM
- K072871 — MS SYSTEM (PROVISIONAL)
- K072888 — REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED, HEMISPHERICAL AND FLARED)
- K072925 — CANDELA-INOLASE SERENITY PRO PSF SYSTEM
- K073068 — ACCIN HIP SYSTEM
- K073088 — SPY FLUORESCENT IMAGING SYSTEM
- K073130 — SPY FLUORESCENT IMAGING SYSTEM
- K073152 — PC-180 / PRINCE 180 EASY ECG MONITOR
- K073632 — INTUITION, MODEL 0170
- K070945 — ASAHI PTCA GUIDE WIRE
- K071287 — ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO
- K071289 — ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO
- K071291 — ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100
- K072265 — PROGENIX DMB PUTTY
- K072367 — REPIPHYSIS LIMB SALVAGE PROXIMAL FEMUR AND TOTAL FEMUR
- K072432 — F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE
- K072566 — HANGER CRANIAL BAND
- K072834 — SIBEL SA VASCULAR CLAMP
- K072881 — NEOMED Enteral FEEDING TUBE
- K072963 — DEPUY PINNACLE ALTRX ACETABULAR LINERS
- K073082 — CPS COURIER GUIDEWIRE
- K073169 — SCIMAGE PICOMENTERPRISE
- K073296 — TEMPXN28
- K073472 — VACCESS PTA BALLOON DILATATION CATHETER
- K073479 — KINETIC-SL ANTERIOR CERVICAL PLATE SYSTEM
- K073495 — TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT
Data sourced from openFDA. This site is unofficial and independent of the FDA.