FDA 510(k) clearances — page 821
clearances on record, most recent first.
Clearances — page 821
82,001–82,100 of 175,890- K001923 — REGENCY POWER WHEELCHAIR, MODEL 7200, 7500 & 7800
- K001991 — TITAN POROCOAT HIP PROSTHESIS
- K002020 — LACTOSORB MENISCAL SCREW
- K002070 — BIOLOK SCREW
- K002100 — XIMX SYSTEM
- K002129 — FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGEN
- K002157 — RANGER II M6, MODEL IN-888WNL
- K002167 — KARMAN WHEELCHAIR
- K002200 — CAPELLA
- K002202 — KARMAN WHEELCHAIR
- K002260 — SPINA SYSTEM
- K002271 — 2.4MM CORTEX SCREW, SELF-TAPPING
- K002277 — FRESENIUS OPTIFLUX 200NR
- K002287 — WIZAIR COMPRESSION SYSTEM
- K002317 — MODEL 9000 BARIATRIC WHEELCHAIR
- K002365 — DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET
- K002388 — EHC500 DESKTOP PATIENT STATION, MODEL EHC500
- K002491 — COMBISON 301 PW ULTRASOUND SYSTEM AND TRANSDUCERS
- K992831 — AERONEB II, MODEL APN 200
- K994198 — HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L
- K000158 — VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9
- K000401 — VAPOTHERM, MODEL 2000I
- K000718 — CHROMOSTREAK
- K001560 — ODONTOSURGE 3
- K001633 — LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 & LHCEK0000
- K001636 — C-REACTIVE PROTEIN ANTISERUM KIT
- K001666 — MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM
- K001720 — SYNTHES SACRAL BAR SYSTEM
- K001759 — HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ
- K001847 — ANTERIOR CERVICAL PLATE SYSTEM
- K002021 — HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE
- K002206 — HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS GUIDE WIRE WITH HYDROCOAT HYDRO
- K002298 — SUPER 1
- K002324 — MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA
- K002435 — MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK)
- K000355 — 3M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR
- K000859 — OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1
- K001814 — DATEX-OHMEDA COMPACT AIRWAY MODULE M-CAIOVX AND M-COVX (VERSION 01) AND ACCESSORIES
- K001943 — CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY
- K002240 — RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0
- K002434 — PALM PUMP
- K993950 — CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999
- K000475 — BRACHYSEED
- K000969 — MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1
- K001598 — BIOBAR, IMPLANTABLE BIODEGRADABLE COLLAGEN MEMBRANE FOR GUIDED BONE REGENERATION
- K001740 — KSEA MONOPOLAR VAPORIZATION ELECTRODES
- K001881 — IMPROVED ENLIGHT LV
- K001935 — ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565
- K002065 — PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GR
- K002148 — ELECSYS HCG TEST SYSTEM
- K002174 — DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3
- K002223 — EPIC SPO2 FINGER SENSOR, MODEL E412-20
- K002238 — CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.