FDA 510(k) clearances — page 738
clearances on record, most recent first.
Clearances — page 738
73,701–73,800 of 175,825- K021509 — HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089
- K022517 — USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY
- K023241 — TELEGRAPH HUMERAL NAIL
- K023349 — CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)
- K023370 — CHEETAH I.V.D.S., MODEL 2002P
- K023634 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-GENTAMICIN GN (0.25-16UG/ML)
- K023667 — RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE
- K023731 — QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), LEVELS 1, 2, AND 3
- K023784 — RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER
- K023841 — AMMONIA ASSAY FOR THE ADVIA 1650
- K023961 — SCOUT BOSS
- K023962 — NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160
- K024107 — FEMOSTOP FEMORAL COMPRESSION SYSTEM
- K021775 — LTFS230
- K022086 — AIM-V (R) MEDIUM, MODEL 087-0112
- K022500 — DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE
- K022690 — PAROS CRP
- K023239 — AIA-PACK CA 19-9
- K023240 — ST AIA-PACK CA 19-9
- K023246 — AMALGA PACS
- K023247 — CHAMPION 5000 PERIPHERAL VASCULAR COIL
- K023269 — HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS
- K023272 — DISPOSABLE ASPIRATION NEEDLE NA-200H
- K023293 — MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02
- K023322 — CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM
- K023339 — IMAGETILE
- K023340 — CORONIS 1MP MEDICAL FLAT PANEL DISPLAY SYSTEM
- K023341 — CORNIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM
- K023396 — AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)
- K023527 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN - 0.25-16 UG/ML
- K023719 — MP-1 MICRO PERIMETER
- K023877 — Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PLUG-IN
- K023964 — RUSCH MICROLARYNGEAL TUBE
- K012691 — MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES
- K013113 — MODIFICATION TO NANMA VACUUM PUMP
- K021115 — GYNEFLEX
- K021500 — VACUUM ASSISTED CLOSURE
- K021826 — TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES
- K021953 — MITEK PDS/PGA STAPLE
- K022147 — DENTA PORT
- K022607 — SPECTRAPULSE
- K022914 — RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES
- K023154 — VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02
- K023160 — DRX5000
- K023193 — CANDELA GENTLE YAG LASER SYSTEM
- K023353 — SYDNEY IVF HYALURONIDASE
- K023382 — COOPERSURGICAL MALLEABLE SYTLET
- K023480 — ACCESS TOTAL BHCG
- K023554 — DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE
- K023567 — STAT PROFILE PHOX PLUS L ANALYZER
- K023858 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
- K023870 — FLEXIMA BILIARY CATHETER
- K023883 — HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO
- K023922 — COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197
- K023936 — MODIFICATION TO MEDIPRIME
- K023975 — VOYAGER LINUX
- K024033 — XTJF-160AF DUODENOVIDEOSCOPE
- K024036 — PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL IF-5000
- K024055 — TILITE EVO
- K024060 — MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM
- K024106 — NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, VITAMIN E AND PROTEIN CLAIM
- K024121 — NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, ALOE, VITAMIN E AND PROTEIN CLAIM
- K014215 — VIABIL BILIARY ENDOPROSTHESIS
- K021637 — ACELL UBM LYOPHILIZED WOUND DRESSING
- K021803 — REFLECTION CONSTRAINED LINER
- K021915 — TRANSITIONAL IMPLANTS
- K022660 — BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117
- K022715 — COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SUTURE
- K023137 — PHILIPS EASYVISION WORKSTATION RELEASE 6
- K023143 — ECHO SOUNDER, ES-102EX
- K023264 — MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110
- K023280 — OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES
- K023411 — STEELEX STERNUM SET
- K023450 — BIOPSY SITE TISSUE MARKER DEVICE
- K023669 — MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONTROL, DADE CARDIAC TL LOW LEVEL LIQUID ASSAYED CARDIAC MA
- K023862 — NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER
- K024011 — SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES
- K024098 — COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
- K011723 — ANTI-SNORING DEVICE OR ASD
- K022713 — DFA RESPIRATORY VIRUS SCREENING & ID KIT
- K022944 — AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA
- K022945 — AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA
- K022979 — LAPARETTE, MODEL LAP J L S H N
- K023115 — ACE VERSANAIL
- K023119 — BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B
- K023125 — COALESCENT U-CLIP- AND ACCESSORIES
- K023173 — ANDREWS INTRODUCER, MODEL ASI01
- K023225 — PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE
- K023271 — TERUMO SYRINGE WITH/WITHOUT NEEDLE
- K023374 — GROSHONG NXT DUAL LUMEN PICC CATHETERS
- K023501 — GOLD CORE 35
- K023502 — JEWEL CAST PLUS
- K023595 — BURETTE-IN LINE (150 ML)
- K023702 — POWDER-FREE NITRILE EXAM GLOVES, COLOR: BLUE
- K023893 — ST AIA-PACK CEA ENZYME IMMUNOASSAY
- K023907 — CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER
- K023996 — ALOKA SSD-3500 ULTRASOUND SYSTEM
- K024025 — POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, VIOLET COLOR
- K024026 — DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
- K024034 — OCCLUFAST ROCK
Data sourced from openFDA. This site is unofficial and independent of the FDA.