FDA 510(k) clearances — page 571
clearances on record, most recent first.
Clearances — page 571
57,001–57,100 of 176,542- K081110 — SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM
- K081142 — AUTO-BAND LIGATOR
- K071512 — GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS
- K072817 — ECHELON TITANIUM HIP SYSTEM
- K073285 — PEEK PREVAIL CERVICAL INTERBODY DEVICE
- K073562 — MODIFICATION TO VIPER SPINE SYSTEM
- K080227 — ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM
- K080374 — BIOSYAG MEDICAL SYSTEM
- K080411 — PLATEAU SPACER SYSTEM
- K080452 — COLLAGEN TENDON WRAP
- K080582 — MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA
- K080587 — EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE
- K080662 — GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR
- K080694 — OSTEOMED MODULAR LOCKING FIXATION SYSTEM
- K080762 — IB NEURO, VERSION 1.0
- K080818 — HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING
- K081090 — PROFEMUR LX 5/8 COATED HIP STEM
- K081253 — ZIRDENT CAD/CAM BLOCKS
- K071130 — HEARTRAK AF
- K071915 — CPAP MASK
- K072749 — SIALO BALLOON DILATATION CATHETER
- K073217 — INCLUSIVE IMPLANT ABUTMENTS
- K073622 — EASY GRIP DENTAL IMPLANT SYSTEM
- K080128 — SM-EXTRA WIDE (RBM) IMPLANT SYSTEM
- K080153 — SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM
- K080165 — SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK AND GRAY)
- K080328 — MPS ACACIA ENTERAL FEEDING TUBE
- K080701 — SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION
- K080726 — CALYPSO 4D LOCALIZATION SYSTEM
- K080752 — CONCEIVEX LATEX-FREE SEMEN COLLECTOR
- K080769 — INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C
- K080977 — 3 CCD ENDOCAM 5550
- K081084 — COLORISE RIGID
- K081155 — SMARTSET MV BONE CEMENT
- K081163 — SMARTSET GMV GENTAMICIN BONE CEMENT
- K081214 — STYLA MICROLASER AND STYLAORTHO
- K081341 — REINFORCED CATHETER INTRODUCER SYSTEM (RCIS)
- K073177 — PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM
- K073311 — OSTEOTRANS-OT PIN
- K073312 — OSTEOTRANS-OT SCREW
- K073411 — LITEDUO
- K080007 — GRADUATED ADAPTER WITH CLAVE
- K080250 — LEKSELL SURGIPLAN, MODEL 1006947
- K080314 — SPINAL USA INTERBODY FUSION DEVICE
- K080337 — MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MQ1-2D
- K080385 — CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR
- K080400 — ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT
- K080462 — PROGENIX DBM PUTTY
- K080549 — DURAFINISH ALL-CURE, MODEL S296
- K080575 — CORRIDOR4DM
- K080660 — IV ADMINISTRATION SET
- K080665 — NOVOLET
- K080738 — DENTRON SENSOR
- K081251 — MODIFICATION TO AESKULISA DS DNA G
- K073097 — TUTODENT DENTAL MEMBRANE
- K080238 — MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER
- K080607 — CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160
- K080750 — BROWNE RAPICIDE GLUTARALDEHYDE INDICATOR
- K080759 — THERMOFLASH LX-26
- K080891 — REVOLUTION 45MHZ IVUS IMAGING CATHETER
- K080936 — CONFORMIS TOTAL KNEE REPIAR SYSTEM (ITOTAL) TIBIAL COMPONENT: 6.0 MM THICKNESS
- K080998 — DORIPENEM 10UG BBL SENSI-DISC
- K081228 — CAPSURE PS (R) SPINE SYSTEM
- K063583 — ALCON VISION SYSTEM
- K072410 — KSEA CLEARVISION II, MODEL 40334120
- K072595 — OMNI-TIGHT
- K072616 — AXXENT VAGINAL APPLICATOR
- K073477 — PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS
- K080140 — LAURIMED SPINAL INJECTION SYSTEM
- K080177 — WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV
- K080187 — OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS
- K080256 — PULMODYNE CHF FLOW GENERATOR SYSTEM
- K080359 — EVOLUTION ESOPHAGEAL STENT SYSTEM
- K080401 — SHELL CAGE, WAVE CAGE, LOOP CAGE
- K080584 — METHA SHORT STEM HIP SYSTEM
- K080612 — LEICA FL800
- K080655 — CHRYSALIS
- K080674 — PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM
- K080742 — VERISUITE 1.6, VERISUITE-PARTICLE 1.6
- K080999 — PAGEWRITER CARDIOGRAPH
- K081014 — SOYALA GEL VENTED
- K081036 — 4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS)
- K081067 — FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)
- K081105 — GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0)
- K081179 — MAMMOSITE CAVITY EVALUATION DEVICE
- K071999 — POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K072084 — POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K072251 — MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM
- K072456 — DESARA MESH SLING, MODEL CAL-DS01
- K073207 — OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167
- K073370 — TC MATRIX CLINICAL CHEMISTRY ANALYZER
- K073675 — T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP
- K080012 — PLATELIA LYME IGG ASSAY
- K080202 — ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT
- K080313 — MODIFICATION TO EXPEDIUM SPINE SYSTEM
- K080437 — MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF
- K080625 — SMITH & NEPHEW MIS HIP STEM WITH STIKTITE
- K080654 — PAJUNK'S KIT FOR BALLOON AIDED LAPAROSCOPY
- K081136 — LYRIC HEARING AID
- K081162 — TEMPTOUCH DERMAL THERMOMETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.