FDA 510(k) clearances — page 668
clearances on record, most recent first.
Clearances — page 668
66,701–66,800 of 176,637- K042018 — ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM
- K042927 — VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES
- K042944 — HOME-AWAY SYSTEM, MODEL 1041
- K042965 — TOMAS PIN
- K043250 — STRYKER PATIENT SPECIFIC POLYMER IMPLANT
- K043328 — MICROFLO-SAFE SCALP VEIN SET
- K043419 — P&P SAFETY SYRINGE
- K043500 — FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE
- K050101 — THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10
- K050153 — SPIRIT, MODEL HAS
- K050254 — SPECTRA-SP CO2 LASER SYSTEM
- K050358 — ARTHERX CORKSCREW FT II SUTURE ANCHOR
- K050506 — PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS
- K050601 — SMARTDOP 45 VASCULAR DOPPLER
- K050604 — KERR VPS IMPRESSION MATERIAL
- K050699 — MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004
- K050700 — MATRIX STRETCH RESISTANT (SR) COILS
- K050706 — HARMONY PORT SYSTEM, MODEL 1907 SERIES
- K042495 — CUMULASE
- K043614 — VACULINK, MODEL VCL 3000
- K050474 — VEINNOVATIONS INFILTRATION SYSTEM
- K050511 — THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT
- K050532 — CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WA
- K050555 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GP) 2-32 UG/ML
- K050562 — OCULIGHT GL/GLX
- K050769 — QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION - 100G - 1.9MM - 2.4MM., MODEL 100172
- K050770 — MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT
- K050867 — SYNGO BODY PERFUSION-CT
- K040757 — SIC PRO
- K050038 — RELIANT STENT GRAFT BALLOON CATHETER
- K050046 — REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S
- K050181 — MEDIGLOVES STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES
- K050433 — ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM
- K050517 — JSZ-MULTIPURPOSE SOLUTION
- K050743 — AQUAFLEX 2 (TEFILCON) CONTACT LENS
- K050778 — TELEREHAD 2004
- K042092 — ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM
- K043385 — OSOM HCG COMBO TEST
- K043555 — SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR
- K050343 — REPROCESSED HARMONIC SCALPELS
- K050483 — EVADRI BLADDER CONTROL SYSTEMS
- K050676 — GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU)
- K050796 — AURORA DS, DS APPLICATOR
- K050831 — STELLARTECH COAGULATION SYSTEM 2, MODELS 1100C-115A AND 1100C-230A
- K042565 — ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER
- K043053 — MODIFICATION TO CD HORIZON SPINAL SYSTEM
- K050193 — GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR
- K050279 — AXS-1 LITE WHEELCHAIR
- K050280 — RUNABOUT WHEELCHAIR
- K050281 — TRANSPORT SERIES TRANSPORT CHAIR
- K050414 — PLIX
- K050490 — OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER
- K050607 — SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO)
- K050624 — STRYKER SPINE AVS PL PEEK SPACER
- K050631 — SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION
- K050666 — GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES
- K050675 — EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE
- K050761 — ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM
- K050774 — LANX ANTERIOR CERVICAL PLATE SYSTEM
- K050804 — MODIFICATION TO: SPECTRUMTM CERVICAL SPINAL SYSTEM
- K050819 — CHARLOTTE SNAP-OFF SCREW
- K041515 — TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE
- K042958 — DUREX PLAY TINGLING LUBRICANT
- K043253 — VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS
- K043443 — ONE STEP HCG URINE PREGNANCY TEST
- K043512 — EASYGLUCO IGM-0002 G2
- K043529 — ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE
- K043543 — BLOOD GLUCOSE MONITORING SYSTEM
- K050083 — BLOOD-PRESSURE METER, BPW120
- K050244 — MALE NATURAL RUBBER LATEX CONDOM
- K050622 — HRW-63-8 WRIST ARRAY COIL; HRW-127-8 WRIST ARRAY COIL
- K050663 — TRAXYLOC-1 SYSTEM
- K050692 — FLXIS
- K050704 — MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING
- K050765 — LANO-E POWDER-FREE NITRILE EXAMINATION GLOVE
- K050771 — LUPINE LOOP
- K042007 — ZOLL E SERIES DEFIBRILLATOR
- K042411 — ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY
- K042710 — SURGITRON RADIOLASE II
- K050207 — BD POSIFLOW POSITIVE DISPLACEMENT VALVE
- K050225 — HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM
- K050376 — PROWIN
- K050377 — NBD HEAD SCREW
- K050408 — BICON ORTHODONTIC IMPLANT SYSTEM
- K050485 — 20.8-INCH(53CM) MONOCHROME LCD MONITOR MDL2110A (ME351I), (DV3MM-HB)
- K050598 — POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE)
- K050602 — ALTAIRE
- K050621 — NVA-127-8-A NEUROVASCULAR ARRAY COIL
- K050628 — ANSPACH COUPLER
- K050641 — ZYGOMA TIUNITE
- K050664 — SPOR-TEST PA BIOLOGICAL INDICATOR KIT
- K050711 — FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168JT
- K050714 — FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168GA, HL168GS
- K043539 — DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES
- K050606 — SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL)
- K050611 — ENDOTINE RIBBON
- K050652 — SPOTCHEM II CREATININE, AMYLASE & ALP TESTS
- K050688 — TEGRESS IMPLANT NEEDLE
- K050740 — MICROWARE 200
- K050750 — LC BRACKET ADHESIVE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.