FDA 510(k) clearances — page 591
clearances on record, most recent first.
Clearances — page 591
59,001–59,100 of 176,637- K063035 — SLEUTH IMPLANTABLE ECG MONITORING SYSTEM
- K070411 — AMSURE NEBULIZER
- K071397 — DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES
- K071480 — LIAISON 25 OH VITAMIN D TOTAL; ASSAY, CONTROL SET AND SPECIMEN DILUENT SET, MODELS 310600, 310601 AND 310602
- K071938 — MONACO RTP SYSTEM
- K072171 — GATECT-RT
- K072468 — MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM
- K072624 — ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT
- K061519 — MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM
- K070822 — ARCHITECT SIROLIMUS ASSAY
- K071056 — NEUTROPHASE WOUND CLEANSER
- K071250 — CA, MODEL: CAM
- K071533 — FITMATE SERIES
- K071727 — QXT EXTRACTION CATHETER
- K071830 — DEPUY DELTA TS CERAMIC FEMORAL HEADS
- K071845 — RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A
- K071920 — AUTOSUTURE ABSORBABLE TACK AND APPLICATOR
- K072069 — SPACER
- K072429 — MODIFICATION TO TSRH SPINAL SYSTEM
- K063637 — RELIANCE VBS SYSTEM
- K063838 — LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH
- K071578 — BLOODSTOP AND BLOODSTOP IX HEMOSTATIC GAUZE, MODELS BS-10,BS-11,BS-12,B-13, BS-IX27, BS-IX-14, BSIX-15, BSIX-17
- K071708 — I45, I45S, I60, AND I60S
- K071762 — OMNIWAVE ENDOVASCULAR SYSTEM
- K071800 — PHILIPS AVALON FETAL MONITORS FM20 AND FM30
- K072095 — SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS
- K072413 — MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM
- K072493 — ENSEAL TISSUE SEALING DEVICE
- K070156 — BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100
- K070339 — DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES
- K070881 — LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660
- K071357 — P.004 NC ANATOMIC ABUTMENTS
- K071919 — P.004 ABUTMENTS
- K071962 — VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER)
- K071964 — MIM 4.1 (SEASTAR)
- K071998 — ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT
- K072296 — POIINT OF CARE STRANDING SYSTEM, MODE 1004-00
- K072355 — OSSIFUSE BONE SUBSTITUTE MATERIAL
- K072431 — ASAHI PTCA GUIDE WIRE, X-TREME
- K072497 — P.004 NC GOLD ABUTMENT FOR CROWNS
- K072517 — ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3
- K070556 — BRAINSUITE NET
- K071457 — MODIFICATION TO RADIUS SNARE
- K071744 — AVIAFIT PULSATING LEGBAND
- K071805 — NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX
- K071970 — CLEAR IMAGE ALIGNER
- K072203 — HARMONIC 10CM COMBINATION HOOK BLADE
- K072392 — OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM
- K072541 — SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM
- K072542 — MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR
- K063675 — DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT
- K070432 — GENERAL SURGERY DRAPES
- K070809 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-32 UG/ML
- K071346 — IMMULISA INTRINSIC FACTOR ANTIBODY ELISA
- K071510 — HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950
- K071732 — MARROWMINER
- K071741 — TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
- K072443 — VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY
- K063798 — DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000
- K063861 — GS SYSTEM
- K070276 — MODIFICATION TO PASSMED SPINAL SYSTEM
- K070291 — MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX
- K070937 — MULTIPLE BRAND MALE LATEX CONDOM
- K071133 — APEXNRG-BLUE ELECTRONIC APEX LOCATOR
- K071431 — GLOBUS GENESY 1100 STIMULATOR
- K071472 — PLANET 55
- K071615 — FIXAFLOSS
- K071982 — MODIFICATION TO: UNITY NETWORK ID
- K072224 — ZIP'R PC
- K072244 — PLANMECA PROONE
- K072279 — MAGNETIC RESONANCE DIAGNOSTIC DEVICE
- K072311 — TILITE AERO X
- K072318 — POWRSYRINGE INJECTOR
- K072337 — WU'S 4-WHEELED NEO SCOOTER, MODEL WT-M4A
- K072338 — CERVITEC PLUS
- K072345 — POWRSYRINGE MONITOR
- K072384 — MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE
- K072504 — CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
- K072514 — VISULAS TRION
- K061539 — GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE
- K063297 — LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR
- K070478 — P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP)
- K071439 — ZIMMER PATIENT-SPECIFIC ABUTMENT, INTERNAL HEX, TITANIUM
- K071816 — HARPOON SUTURE ANCHOR
- K071827 — ALWAYS MENSTRUAL PADS
- K071859 — STRYKER CROSSFIRE SYSTEM
- K071945 — S4 SPINAL SYSTEM
- K072034 — DIODE MEDICAL LASER FAMILY, MODELS 4, 6, 30
- K072062 — UCP MULTIPLE DRUG SCREEN TEST CUPS
- K072161 — BIOMET FEMORAL LOCKING NAIL SYSTEM
- K072368 — CONFORMIS METAL BACKED TIBIAL COMPONENT
- K072440 — VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208)
- K072489 — REVOLUTION TD-4229 BLOOD GLUCOSE MONITORING SYSTEM
- K072515 — EMBRACE GEL
- K062003 — NEURO WAVE 6
- K063735 — PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112
- K070816 — PERIPHERAL GUIDING SHEATH
- K070922 — MODIFICATION TO SPINAL USA VBR SYSTEM
- K070979 — PULL TAB SQUEEZE FLUSH
- K071071 — CROSSLINKED POLYETHYLENE ARTICULAR INSERTS
Data sourced from openFDA. This site is unofficial and independent of the FDA.