FDA 510(k) clearances — page 839
clearances on record, most recent first.
Clearances — page 839
83,801–83,900 of 175,890- K000056 — BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS
- K000220 — MA-300 ELECTROMYOGRAPHY SYSTEM
- K000316 — MERETEK UBT_LITE BREATH TEST FOR H. PYLORI
- K000572 — E.N.S.I. SYRINGE
- K991346 — PH-100, MODEL 2104
- K992638 — DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400
- K993514 — DEFINITE
- K994014 — ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHT
- K994033 — HORTMANN ECHOMASTER OAE ANALYZER
- K994369 — 7250 (MEGAS)
- K000002 — MAGNA 5000 PHASED ARRAY CTL SPINE COIL
- K000210 — MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT
- K000257 — IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6
- K000364 — ACCU-CHEK COMPLETE METER
- K000365 — ACCU-CHEK ADVANTAGE METER
- K992290 — EXEL INJECTION PLUG WITH CAP
- K993633 — SYNTHETIC VDRL ANTIGEN
- K994182 — PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE
- K994318 — VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
- K994324 — ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
- K994356 — IMMUNOCYT
- K994421 — SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION
- DEN990002 — KAVO DIAGNODENT
- K000166 — SYNTHETIC (WHITE) VINAL POWDERED PATIENT EXAMINATION GLOVES
- K000228 — ENTEC CONTROLLER, ENTEC PATIENT CABLE, FOOTSWITCH, POWERCORD, PLASMA WAND
- K991571 — 10 CURIE IRDIUM 192, CSN00100-192
- K992214 — OXYCON PRO
- K992461 — STEALTHSTATION TREATMENT GUIDANCE PLATFORM
- K992537 — PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED
- K992940 — LEMAITRE BALLOON CATHETER WITH IRRIGATION
- K993974 — SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR
- K993976 — PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR
- K993979 — MARSPO2, MODEL 2001
- K993990 — LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM
- K994021 — CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION
- K994228 — REMOTEIMAGE SYSTEM
- K994275 — SIMS PORTEX ANESTHESIA CATHETER
- K000055 — CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17
- K000070 — FLOCATH
- K000128 — HARDYDISK, CEFAZOLIN, 30MCG
- K000132 — ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8
- K000156 — SMART SHIELD NON-STERILE POWDER-FREE PEPPERMINT SCENTED GREEN LATEX EXAMINATION GLOVES
- K000174 — ACTION AF-1 WHEELCHAIR
- K000196 — ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316
- K000217 — ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDERED LATEX EXAM WITH PROTEIN LABELING CLAIM [<200 MCG OR LESS] W
- K000360 — RX G-UNIVERSAL
- K000362 — MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM
- K000363 — MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
- K983943 — MICROSTREP PLUS PANEL, LEVOFLOXACIN
- K991345 — ASP-100, MODEL 2100
- K992359 — MRS-TITAN
- K992445 — MED-GUARD SURGEON'S GOWN
- K992539 — PERCUGUARD
- K992657 — IBC VRV, MODEL 1350
- K993951 — SPOT ENDOSCOPIC MARKER
- K993965 — CRYO-HIT
- K993966 — 8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER
- K994076 — IMPLEX HEDROCEL PS TIBIAL COMPONENT, MODEL HEDROCEL POSTERIOR STABILIZED TIBIAL COMPONENT 05-XXX-YYYYY
- K994100 — PACIFIC HEMOSTASIS THROMBOPLASTIN D
- K994122 — BONE GRAFT WASHER, MODEL 9090114 - 9090118
- K994143 — SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]
- K994244 — CONVERTORS SURGICAL GOWNS, STERILE
- K994298 — FRIOS MICROSAW
- K994361 — ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL
- K994379 — EU-TTG IGA ELISA
- K994424 — DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM
- K000022 — HARDYDISK CEFAMANDOLE, 30MCG
- K000119 — SJM TAILOR ANNULOPLASTY RING, MODEL TARN
- K991737 — LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR
- K992556 — PERMACOL
- K994134 — HARDYDISK OXACILLIN, 1MCG
- K000159 — AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO
- K000236 — SYNERGY VLS CAP NUT MODELS 2206, 6102
- K000242 — ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE
- K000295 — ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K000334 — IMPACT MODULAR TOTAL HIP SYSTEM
- K000379 — MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352
- K981936 — ABD VARISOFT STEERABLE GUIDE WIRE AND ABD VARISOFT GUIDE WIRE EXTENSION
- K984565 — TMC-EASY-302
- K992751 — SOMAVISION
- K993332 — GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05
- K993846 — ULTRASEAL XT PLUS
- K993872 — VANNA BATHING SYSTEM
- K994012 — TEMPOFIT, MODEL 02693
- K994135 — HARDYDISK ERYTHROMYCIN, 15MCG
- K994150 — HARDYDISK NORFLOXACIN, 10MCG
- K994314 — CASTLE SERIES 100HC STEAM STERILIZERS
- K994425 — MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM
- K994432 — HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (140 MICROGRAMS OR LESS)
- DEN990008 — WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000
- K000116 — QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3
- K000300 — LIGHTSPEED 2.0CT SCANNER SYSTEM
- K000310 — VOYAGER 6.0 SOFTWARE OPTION
- K991395 — QUINN'S HTF MEDIUM, QUINN'S HTF MEDIUM WITH HEPES, QUINN'S BASAL XI HTF MEDIUM, QUINN'S D3+ HTF MEDIUM
- K991396 — WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L
- K992662 — 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
- K993395 — REMED MALE LATEX CONDOM (DOUBLE WHOOPER) PREVENTOR, LUCKY BOY AND SUMMIT
- K993396 — REMED MALE EXTRA STRENGTH CONDOM PREVENTOR, LUCKY BOY, SUMMIT
- K993404 — REMED MALE LATEX CONDOM (CLASSIC) PREVENTOR, LUCKY BOY, AND SUMMIT
- K993405 — REMED MALE DOTTED CONDOM PREVENTOR, LUCKY BOY, SUMMIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.