FDA 510(k) clearances — page 634
clearances on record, most recent first.
Clearances — page 634
63,301–63,400 of 176,637- K060801 — DEKNA-LOK MODEL BP1000V2L
- K060829 — COSMATRIX
- K060880 — ZIMMER DENTAL ONE PIECE TAPERED ABUTMENT, MODELS TAC1, TACW1, TA5C1
- K060984 — XENFORM SOFT TISSUE REPAIR MATRIX
- K061048 — COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM
- K061064 — COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503
- K061103 — HAEMONETICS 40U RBC FILTER BAG
- K053230 — MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
- K060126 — ABSOANCHOR MICROIMPLANT
- K060775 — POWDER-FREE LATEX PATIENT EXAMINATION GLOVE,WITH EXTRACTABLE PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAM PER GRAM OF
- K060783 — SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL
- K060816 — MIM 4.0 (NEURO
- K060881 — TEMPORARY CROWN & BRIDGE RESIN
- K061111 — TINNITUS PHASE-OUT
- K061177 — PROVIDE TEMPORARY CYLINDER
- K061213 — SONOACE PICO DIAGNOSTIC ULTRASOUND SYSTEM
- K061278 — OPTYSE OPHTHALMOSCOPE
- K052290 — AQUASOFT ALL-DAY & ALL-DAY T (HIOXIFILCON A) DAILY WEAR CONTACT LENS
- K052832 — SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES
- K060135 — MORTARA SURVEYOR TELEMETRY CENTRAL STATION
- K060321 — ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK
- K060442 — PYRENEES CERVICAL PLATE SYSTEM
- K060516 — ELLIPSE 12PL, MODEL 9ESL7228
- K060701 — BISCEM TRANSLUCENT, BISCEM OPAQUE
- K060715 — MODIFICATION TO: CARDIMA ABLATION SYSTEM
- K060870 — AVANZA
- K060934 — MODIFICATION TO POWERHEART ECD
- K060989 — TISSUEMEND SOFT TISSUE REPAIR MATRIX
- K061140 — TRILOGY RADIOTHERAPY DELIVERY SYSTEM
- K061185 — DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE05A AND L-CANE05A SOFTWARE
- K061214 — AQUARIUSAPS SERVER
- K061216 — USGI TRANSPORT ENDOSCOPIC GUIDE
- K052952 — CATHASSIST
- K052690 — SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTS
- K053191 — DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTACT LENS
- K053257 — PARA-PRO FC50
- K060040 — ZIMMER M/L TAPER HIP PROSTHESIS
- K060116 — MICRUS COURIER MICROCATHETERS
- K060323 — ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380
- K060351 — MEDTOX OXYCODONE
- K060396 — IVENA VASCULAR PATCH
- K060479 — MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM
- K060969 — POLYAX LOCKED PLATING SYSTEM
- K061186 — FLIGHT
- K061187 — TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING
- K053405 — BACSTOP
- K053419 — KONICA MINOLTA PULSOX-300, 300I
- K060198 — MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW
- K060247 — LIFE SPINE CEMENT RESTRICTOR
- K060343 — BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000
- K060558 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEPHALOTHIN - GN 1 - 64 UG/ML
- K060586 — ENZYME IMMUNOASSAY, VANCOMYCIN
- K060869 — RS-1000 ZOOM SLITLAMP WITH OPTION
- K060903 — IG4 IMAGE GUIDED SYSTEM
- K051223 — HIPSTAR FEMORAL STEM
- K052308 — ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM
- K052692 — SURETEK MEDICAL REPROCESSED ELECTROSURGICAL ELECTRODES
- K052695 — SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS
- K053244 — LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT
- K060101 — ESTECH AORTIC EASY FLOW CANNULA
- K060284 — CRYOCHECK CLOT APCR
- K060331 — SIGMA ALPHA VAPORIZER
- K060340 — ORAMAGIC PLUS ORAL WOUND RINSE
- K060358 — PROFEMUR TL HIP STEM
- K060386 — NEXA CARPO METACARPAL IMPLANT
- K060656 — SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES
- K060665 — XPAND RADIOLUCENT CORPECTOMY SPACER
- K060698 — CEMENT-IT ALL PURPOSE, MODEL N97
- K060699 — SYNVITRO CUMULASE (HYALURONIDASE MEDIUM)
- K060975 — IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2
- K061000 — EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0
- K061014 — ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
- K061020 — DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE
- K061143 — ROBERTSITE STOPCOCK
- K061148 — RHYTHMLINK DISC ELECTRODES
- K061152 — MUCHECK V7.0
- K053298 — ALPHASPHERE ORBITAL IMPLANT
- K053551 — MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL
- K060155 — 15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS
- K060925 — ACON AUTOMATIC BLOOD PRESSURE MONITOR KIT, MODEL OB11-111, W/AC ADAPTER, MODEL OB11-112
- K060933 — SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM
- K060981 — PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS
- K061030 — BIOBLANKET SURGICAL MESH
- K061054 — AXIOM ARISTOS FX PLUS
- K061126 — ACCUREX
- K053639 — GIVEN DIAGNOSTIC SYSTEM
- K060094 — ARCADIA MEDICAL SILICONE WIRE REINFORCED ENDOTRACHEAL TUBES
- K060099 — S. AUREUS PNA FISH
- K060565 — CONDYLAFORM II NFC
- K060786 — SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVE-POWDER FREE
- K051760 — NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05
- K053035 — ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000
- K053453 — HOMMED CENTRAL STATION, VERSION 3.5
- K060109 — OMI RETRACTABLE SAFETY SYRINGE
- K060112 — NODECREST TRANSCRANICAL DOPPLER ULTRASOUND SYSTEM
- K060246 — INFREX
- K060383 — GLUCOSE
- K060519 — INTRODUCER ASSEMBLY WITH ROTATOR LOCK
- K060560 — ASCENSION PYROSPHERE CMC/TMT
- K060758 — OR HEAD COIL 1.5 T
Data sourced from openFDA. This site is unofficial and independent of the FDA.