FDA 510(k) clearances — page 472
clearances on record, most recent first.
Clearances — page 472
47,101–47,200 of 175,770- K100313 — HYDROFIX SURGICAL SHEET
- K110001 — SPACELABS PATHFINDER SL HOLTER ANALYZER
- K110597 — EV1000 CLINICAL PLATFORM
- K110599 — AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
- K110739 — ENTELLUS MEDICAL SINUS GUIDEWIRE
- K110747 — TEMPFLEX
- K111078 — AEU-26L ELCTRONIC ENDODONTIC SYSTEM
- K111217 — ADDITIVE CAP
- K111244 — TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
- K101990 — ETHICON ENDO-SURGERY GENERATOR G11, MODEL GEN11
- K102458 — 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
- K102507 — AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR
- K110374 — MAX PULSE SYSTEM
- K110927 — MECTALIF
- K110933 — SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
- K102258 — CUSA NXT EXTENDED LENGTH TIP
- K102389 — NAVIGATOR APPLICATIONS SUITE
- K102625 — VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03
- K103584 — ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS
- K103601 — AUDIT MICROCV IMMUNOASSAY LINEARITY SET
- K103736 — DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE
- K110088 — DEFENDO Y-OPSY IRRIGATOR
- K110119 — PRESSURE MANOMETER
- K110133 — EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER
- K110247 — POWDER FREE NUTRILE PATIENT EXAMINATION GLOVES, BLUE COLOR
- K110248 — POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WHITE COLOR
- K110274 — AUTODELFIA NEONATAL IRT KIT
- K110356 — ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT
- K110640 — ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENT
- K110759 — TEMPOCEM
- K110936 — DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT
- K110969 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K111023 — ABBOTT ARCHITECT LH CALIBRATORS
- K111344 — I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560)
- K111471 — EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)
- K102496 — POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS
- K103019 — KJ MASK
- K110273 — AEROVENT PLUS CHC
- K110394 — ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)
- K110850 — K-PACK II NEEDLE- 27G & 30G THIN WALL
- K111016 — SAFEPORT MANIFOLD (TM) (OR STOPCOCK)
- K111020 — ATRICURE DISSECTOR
- K111092 — ENGAGE/ENGAGE TR INTRODUCERS
- K111349 — ELECSYS SHBG CALCHECK 5
- K103429 — BIOGRAPH MMR
- K103637 — ERKA. PERFECT-ANEROID
- K103724 — 10 MP GRAYSCALE FLAT PANEL DISPLAY (GX 1030)
- K110070 — TSRH SPINAL SYSTEM
- K110272 — STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG
- K110284 — NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM
- K110693 — PACEART OPTIMA SYSTEM SOFTWARE
- K110728 — IMESH TACKER
- K110883 — J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA
- K111007 — MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE
- K111111 — ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO
- K111315 — MULTIPURPOSE DRAINAGE CATHETER
- K111339 — HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)
- K111379 — EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHT
- K103086 — DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC
- K110158 — ILLUMINATING SINUS SEEKER
- K101733 — REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES
- K102623 — BLUE POWDERFREE NITRILE EXAMINATION GLOVE
- K103210 — TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS
- K103839 — BEHIND EAR GENTLE TOUCH THERMOMETER
- K110405 — TRUBLUE NASAL MASK
- K110527 — K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE
- K110753 — MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM
- K110972 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR
- K111017 — CLEARTEMP
- K111041 — MINI VARIABLE SYSTEM
- K101627 — IPLAN
- K102566 — OWL CANNULAE
- K102614 — AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40
- K102767 — CARDIO XP
- K103266 — ISTAND
- K110275 — ORTHO EASY PIN
- K110508 — SUGLUE-10
- K110645 — BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR
- K110732 — EMULSION SB
- K110769 — AMSCO WARMING CABINET
- K110829 — ACE STAPLER AND CARTRIDGE
- K111093 — BILLY BOY MALE LATEX CONDOM
- K111292 — LUMINOS AGILE
- K111442 — V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)...
- K111445 — DISCOVERY NM 630
- K100943 — INVADER FACTOR II
- K102461 — FRACTORA
- K102479 — ALARA T210 COMPUTED RADIOGRAPHY SYSTEM
- K102490 — IGX PLEX CELIAC QUALITATIVE ASSAY
- K102567 — WATCH-PAT 200S-3 (WP200S-3)
- K102811 — AOS ORION IR-192 SOURCE CABLE
- K103205 — BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM
- K103548 — ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491
- K103578 — PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST
- K103703 — REGUIS SIGMA
- K103737 — OMNI II PATIENT MONITOR
- K110143 — HET BIPOLAR ELECTROCAUTERY FORCEPS
- K110617 — MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER
- K110658 — APTUS CANNULATED COMPRESSION SCREWS
- K110669 — TAMPAX C PLASTIC TAMPONS, UNSCENTED
Data sourced from openFDA. This site is unofficial and independent of the FDA.