FDA 510(k) clearances — page 822
clearances on record, most recent first.
Clearances — page 822
82,101–82,200 of 175,890- K001969 — GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300
- K002008 — SURGICAL DYNAMICS SPINAL RETRACTOR
- K002041 — WILLI GELLER CREATION & AV PORCELAIN
- K002141 — ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT
- K993698 — SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX
- K000685 — CHARTER MEDICAL NEONATAL SYRINGE SET
- K000888 — SANSIBAR CPAP SYSTEM
- K002218 — NITRILE EXAM GLOVE, POWDER-FREE, COLOR BLUE
- K002220 — NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE
- K002419 — SURGICAL DRAPES
- K993934 — V QUICK PATCH
- K000421 — BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE
- K001572 — NEOLUS NEEDLE
- K001604 — DANA DIABECARE
- K001677 — BABY DOPPLEX 4000 (BD4000)
- K001810 — URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING
- K001870 — MILLENNIUM 9000 PHASED ARRAY NEUROVASCULAR COIL
- K001944 — HAC-300 HEAD ARRAY COIL
- K001967 — PVP-POLYVINYLPYRROLIDONE REAGENT, MODEL CAT#2210
- K002112 — RUBBERCARE POLYMER-CHLORINATED POWDER-FREE GUARDIAN POLYMER-CHLORINATED POWDER-FREE
- K002321 — PAIN CARE 2000L
- K970569 — BIO-BLOCKS
- K993806 — DIALGUARD ENDOTOXIN REMOVAL DEVICE
- K994118 — OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS
- K994403 — INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST
- K994406 — INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST
- K000796 — MAGIC MOBILITY 4 X 4 WHEELCHAIR
- K001940 — MICOR ANESTHESIA CONDUCTION KIT
- K002114 — RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES: CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER
- K002181 — GDC ULTRASOFT COIL
- K002216 — NITRILE EXAMINATION GLOVE, PRE-POWDERED, COLOR WHITE
- K002217 — NITRILE EXAM GLOVE, POWDER-FREE, COLOR WHITE
- K993875 — BMT ANSCORE HEALTH MANAGEMENT SYSTEM
- K994124 — NIPROTECT POWDER-FREE NITRILE EXAMINATION GLOVES
- K000114 — RS-4M+MUSCLE STIMULATOR
- K000913 — POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
- K001091 — CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01
- K001403 — SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P
- K001498 — THE FUGO BLADE
- K001523 — ULTIMA METAL-ON-METAL ACETABULAR CUP
- K001565 — STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB
- K001609 — MALLARD AIR OXYGEN ACCUBLENDER
- K001655 — PERMLASTIC 2
- K001799 — DC-TELL
- K001815 — DC ZIRKON
- K001860 — PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA
- K001914 — CLEARFIL REPAIR
- K001953 — PASCO MIC AND MIC/ID PANELS
- K002006 — LIFESHIELD ADDITIVE PIERCING PIN
- K002063 — BIOTRACE, MODEL 1730
- K002171 — INVACARE LIFT CHAIR
- K002190 — POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP)
- K002205 — CARONY
- K002353 — ELECSYS CA 15-3 CALCHECK
- K002364 — PROTEMP H
- K994231 — SIEMENS INTEGRATED OPERATING SYSTEM (SIOS)
- K000574 — IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE)
- K001162 — GOLDFINGER DEVICE
- K001414 — KWIKKMODEL
- K001492 — QUINTON Q-STRESS, MODEL 000483
- K001727 — MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES
- K001764 — HOTLINE 2 FLUID WARMER
- K001887 — MODIFICATION TO PASCO MIC AND MIC/ID PANELS
- K002012 — SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
- K002015 — SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
- K002116 — S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0
- K002118 — STOCKERT COMPACT SYSTEM VERSION 2.0
- K002221 — KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170
- K993913 — TRUE
- K000388 — CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)
- K000736 — LA JOIE
- K001404 — GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON
- K001406 — HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES
- K001978 — 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9
- K002225 — OR TABLE/MAGNETOM OPEN VIVA SYSTEM
- K002239 — SIGMA 110/330 DIAGNOSTIC ULTRASOUND SYSTEM
- K002258 — ULTRAGUIDE CT-GUIDE 1010
- K001126 — PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST
- K001456 — CONSENSUS KNEE SYSTEM
- K001471 — THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ
- K001547 — ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP
- K001761 — STATLYTE NA/K/CL/LI ANALYZER
- K001767 — DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM
- K002134 — ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
- K002196 — LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483
- K984390 — LACTOSORB PANELS AND FASTENERS
- K994395 — INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST
- K000084 — ENRAF-NONIUS SONOPULS 190 SYSTEM
- K000568 — HDL CHOLESTEROL PLUS
- K000593 — SONIC, MODEL SO-100
- K000653 — AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002
- K000788 — APEX MODULAR HIP STEM
- K001009 — RANDOX C-REACTIVE PROTEIN
- K001448 — TRIDENT ACETABULAR SHELLS: PS-HA
- K001449 — TRIDENT ACETABULAR SHELLS: PS
- K001470 — E-Z LINK CROSS CONNECTOR
- K001476 — TORQUE INSTRUMENT, MODEL 8500
- K001571 — BAUMER FEMORAL HEAD
- K001614 — STRYKER TRAUMA PELVIC SET
- K001645 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
Data sourced from openFDA. This site is unofficial and independent of the FDA.