FDA 510(k) clearances — page 448
clearances on record, most recent first.
Clearances — page 448
44,701–44,800 of 175,770- K120778 — BRIVO MR355
- K110535 — ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION
- K120270 — VENUS SPINAL FIXATION SYSTEM
- K120572 — BIOPLEX 2200 TORC IGG
- K103704 — REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP
- K110520 — BIOLIS 12I
- K111501 — I-LIPO SYSTEM
- K112064 — RESORB X-G
- K112377 — BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER
- K112469 — GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM
- K113304 — BLADDER SCANNER
- K113733 — SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX
- K113748 — IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)
- K113866 — PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX
- K120049 — BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
- K120538 — PALLS M SPINAL SYSTEM
- K120593 — MYOSURE CONTROL UNIT
- K120602 — APACERAM BONE GRAFT SUBSTITUTE
- K120743 — SPECULUM, VAGINAL, NONMETAL
- K111702 — AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE
- K112478 — VISI MOBILE MONITORING SYSTEM
- K112573 — EZSLEEP SLEEP QUALITY RECORDER
- K113051 — SPACELABS ARKON ANESTHESIA WORKSTATION
- K113117 — NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX
- K113220 — EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
- K113265 — GENII GI 4000 ELECTROSUGICAL GENERATOR
- K113441 — PHYSIOLOGICAL MONITOR, PATIENT MONITOR
- K113657 — INTELLIVUE PATIENT MONITOR
- K113798 — INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET
- K102900 — HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM
- K112005 — NON-STERILE, POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K112012 — NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES
- K112432 — ZOLL X SERIES
- K112887 — UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR
- K113357 — POSEY BED
- K113818 — EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL
- K113865 — PULTOL
- K120070 — SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM
- K120154 — INTRAUTERINE INSEMINATION (IUI) CATHETER
- K103623 — NEWDEAL INTERPHALANGEAL IMPLANT
- K111756 — V1 SYSTEM
- K112100 — M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER
- K112411 — MAMMOTOME ELITE BIOPSY SYSTEM
- K113122 — PIPELINE CR PRIMARY KNEE SYSTEM
- K113475 — ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM
- K120363 — SYNGO RT INTERFACE
- K120540 — BIOBOLT
- K110536 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K112078 — ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)
- K112268 — CODAN SAFEFEED ENTERAL FEEDING RESERVOIR
- K112392 — HIVOX BIOTEK INC.
- K112682 — METHA HIP SYSTEM
- K113618 — CLEARCORRECT SYSTEM
- K113808 — THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)
- K113854 — PLEURX PERITONEAL CATHETER SYSTEM
- K120197 — ABL90 FLEX
- K120453 — FILTEK BULK FILL FLOWABLE RESTORATIVE
- K120544 — RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN
- K120557 — SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35
- K110337 — UNIVERSAL MAXILLARY MOLAR
- K111541 — ENDO-EXPRESS (R) HANDPIECE
- K112154 — FEMTO LDV
- K112718 — NUVASIVE NVM5 SYSTEM
- K113239 — FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF)
- K113320 — NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12
- K113420 — RNARETAIN
- K113474 — 1.5T GEM FLEX COIL
- K113515 — HORIZON CARDIOLOGY ECG MANAGEMENT
- K113558 — BD BACTEC Plus Aerobic/F Culture Vials (plastic)
- K113763 — SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE
- K113766 — CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRAN
- K113788 — DEFLEX ACRILATO
- K113811 — V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM
- K120031 — CHESAPEAKE SPINAL SYSTEM
- K120060 — E-CUBE 9
- K120188 — ELECTROCARDIOGRAPH
- K120373 — INSORB ABSORBALBE STAPLE
- K120480 — GORE(R) EMBOLIC FILTER
- K120485 — NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P
- K111933 — COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0
- K112052 — CAREFUSION NICOLET EDX
- K112404 — CONCENTRIC BALLOON GUIDE CATHETER
- K112998 — AUTOPULSE RESUSCITATION SYSTEM MODEL 1000
- K113090 — LEVEEN SUPERSLIM NEEDLE ELECTRODE
- K113387 — CITIEFFE TITANIUM NAILING SYSTEM
- K113712 — IM-11 PNEUMATIC MICROINJECTOR
- K113749 — DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR
- K113777 — QUIDEL MOLECULAR INFLUENZA A+B
- K113791 — B-GENIN, R-GENIN
- K120120 — AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AMPLATZER TORQVUE LA1 DELIVERY SHEATH AMPLATZER TORQVUE LA2 SELIVERY SHEATH
- K120608 — ENDOSCOPIC APPLICATOR
- K120660 — CONQUEST 40 PTA DILATATION CATHETER
- K120677 — CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014)
- K102189 — POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM
- K111820 — SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGE
- K112902 — ENFLOW IV FLUID WARMER
- K112969 — AIR-BAG SYSTEM
- K113700 — VIAVALVE SAFETY IV CATHETER
- K113756 — HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA
- K120074 — FOUNDATION SPINAL SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.