FDA 510(k) clearances — page 829
clearances on record, most recent first.
Clearances — page 829
82,801–82,900 of 176,637- K002340 — VINYL EXAMINATION GLOVE, POWDER-FREE, YELLOW
- K001392 — GLYCOSAL HBA1C TEST
- K001411 — WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056
- K001462 — CARESIDE HEMOGLOBIN
- K001556 — HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY
- K001683 — SYSMEX R-500
- K001875 — DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM
- K001981 — DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500
- K002120 — LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573
- K000209 — DOSE 1
- K001325 — FLO ASSISTANT, MODEL 4-250-00
- K001589 — CANDELA DYNAMIC COOLING DEVICE
- K001615 — HUNTER SCIENTIFIC INJECTION PIPETTES
- K001653 — XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY
- K001773 — ORTHONE
- K001827 — PARADIGM SOF-SET MICRO QR, MODELS 324 AND 325
- K001828 — PARADIGM 1.5ML RESERVOIR, MODEL 326
- K001829 — MINIMED PARADIGM INSULIN PUMP, MODEL 511
- K001832 — PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318
- K001908 — KONTUR 55 SOFT LENS
- K002194 — TREATVISION
- K002209 — GE MARQUETTE ECG ANALYSIS PROGRAM
- K002230 — CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002
- K002279 — ML EYE SPEAR, MODEL ML 27 ES
- K002415 — POWERDRIVE 350 OPTION
- K993389 — REMED MALE TUTTI FRUTTI CONDOM (BANANA), PREVENTOR, LUCKY BOY, SUMMIT
- K993403 — REMED MALE TUTTI FRUTTI CONDOM (STRAWBERRY) PREVENTOR, LUCKY BOY, SUMMIT
- K993409 — REMED MALE TUTTI FRUTTI CONDOM (COCONUT) PREVENTOR, LUCKY BOY, SUMMIT
- K000605 — STACKHOUSE LENS HOOD, MODEL SA-700/F
- K001580 — GROSS FEMORAL COMPONENT
- K001588 — ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20
- K001793 — SYNTHES SCALLOPED DISTAL TIBIA PLATE
- K001858 — OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITE
- K002002 — SUREFIT DISPERSIVE ELECTRODE
- K002018 — NDO SURGICAL SURGICAL OVERTUBE
- K002086 — PRIMAFLOW
- K002281 — STELKAST PROVEN KNEE SYSTEM
- K002314 — LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM; 100 MICROGRAM OR LESS OF TOTAL WATER EXTR
- K002347 — COOLTOUCH II
- K002397 — M2430 DIAGNOSTIC ULTRASOUND SYSTEM WITH THE 21420 TRANSDUCER
- K993042 — MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT
- DEN000007 — QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA
- K001106 — MASTERSITE NEEDLELESS LUER ACTIVATED IV CONNECTOR, MODEL MS 1000
- K001250 — APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)
- K001562 — NEURO SCAN MEDICAL SYSTEMS A4000
- K001706 — WMT MODULAR SHOULDER SYSTEM
- K001823 — LINKMAX
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.