FDA 510(k) clearances — page 691
clearances on record, most recent first.
Clearances — page 691
69,001–69,100 of 175,825- K040588 — SYNTHES (USA) 2.4 MM LCP WRIST PLATE
- K040600 — GENEX BONE GRAFT SUBSTITUTE
- K040679 — RICH-MAR AUTOPRISM INFRARED LAMP
- K040818 — MEDLINE STRIDER MINI 3
- K040838 — MEDLINE STRIDER MINI 4
- K040949 — VIADUCT MINISCOPE AND ACCESSORIES
- K040981 — USW NEEDLEKNIFE PAPILLOTOME
- K041016 — NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS
- K041060 — E-Z LUBRICATING JELLY
- K041065 — PANALOK RC LOOP ANCHOR
- K033273 — DEPUY PINNACLE ACETABULAR CUP SYSTEM, ESL MARATHON POLYETHYLENE LINERS, AND DEPUY ULTIMA UNIPOLAR FEMORAL HEADS
- K033307 — NVISION DATA MANAGEMENT SOFTWARE
- K040225 — OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
- K040397 — MODIFICATION TO CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
- K040801 — INTRA-AORTIC BALLOON (IAB)
- K040893 — EASY CORE BIOPSY SYSTEM
- K041061 — D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS
- K041093 — NUMED MULLINS X PTA CATHETER
- K041099 — MODIFICATION TO SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP
- K030810 — COOLAN 300
- K033018 — STIMULONG PLUS CATHETER SET MODEL, VARIOUS
- K033550 — DXL CALSCAN
- K033670 — GORE TRI-LOBE BALLOON CATHETER
- K033833 — EFLOW ELECTRONIC INHALER/NEBULIZER
- K034033 — RESCAN
- K040069 — DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR
- K040196 — KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS
- K040267 — TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEE
- K040268 — DEPUY PRESERVATION UNICONDYLAR TIBIA
- K040294 — LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 980
- K040410 — GREENLIGHT 300
- K040506 — FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A
- K040536 — MODIFICATION TO VERTE-STACK SPINAL SYSTEM
- K040629 — ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE
- K040641 — ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1
- K040948 — INTUITIVE SURGICAL ENDOPASS ENDOSCOPIC DELIVERY INSTRUMENT, MODEL P/N 400170
- K040983 — LORENZ SELF-DRILLING IMF SCREW
- K041010 — REMSTAR AUTO WITH C-FLEX CPAP SYSTEM
- K033189 — KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305
- K033216 — BZ-576 NON-INVASIVE AUTOMATIC BLOOD PRESSURE MONITOR
- K040146 — INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
- K040376 — SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE
- K040404 — HEARTSTART MRX, MODEL M3535A
- K040877 — ARTOSCAN C
- K040274 — ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE
- K040312 — TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS
- K040427 — FIBREX CATHETER PATENCY DEVICE
- K040514 — EOVIA CALCIUM PHOSPHATE CERAMIC
- K040646 — STRAUMANN GRANULES
- K040669 — CERAFORM BONE VOID FILLER
- K040856 — RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER
- K040936 — PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE
- K041025 — BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED
- K030604 — PERFECT SAFETY SYRINGE
- K031687 — VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
- K033077 — EASYTEM DUO, FOREHEAD/EAR THERMOMETER, MODEL BT-021
- K033198 — APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2
- K040161 — SONA PILLOW
- K040276 — QUANTUM CEMENT RESTRICTOR
- K040289 — SMARTLITE D FREQUENCY DOUBLED ND:YAG LASER
- K040393 — RIVA LUTING
- K040469 — THE STRAUMANN ORTHO IMPLANT SYSTEM
- K040738 — MOBILE OXYGEN STORAGE TANK (MOST)
- K040761 — AXSYM CYCLOSPORINE
- K040827 — PANALOK LOOP ANCHOR
- K040842 — SENORX BIOPSY DEVICE II
- K040843 — HEMOSIL VON WILLEBRAND ACTIVITY
- K040867 — PERIVAC KIT, MODELS 4304, 4305, 4314, 4315
- K040899 — MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP
- K040968 — WU'S 4-WHEELED NEO SCOOTER, MODEL WT-T4D
- K022688 — VERSABOND AB BONE CEMENT
- K032568 — BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193
- K033453 — KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING
- K033755 — MINRAY
- K040008 — QUICKVUE ADVANCE PH AND AMINES GLL TEST
- K040228 — MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122
- K040282 — ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID
- K040540 — MODIFICATION TO LTV 1000 VENTILATOR
- K040690 — SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE
- K040776 — ATLANTIS SR, MODEL C4020; ATLANTIS SR PLUS, MODEL 35975
- K040803 — MS-30 FEMORAL STEM STANDARD AND LATERAL
- K040824 — INTERFERENTIAL STIMULATOR, MODEL BMLS03-6
- K040833 — MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
- K040892 — MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905
- K040917 — PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B
- K040998 — MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH
- K031457 — ENDOMAT LC PUMP, MODEL 20 3303 20
- K031664 — ELEMENTS OBTURATION UNIT
- K040340 — K-Y BRAND WARMING ULTRAGEL PERSONAL LUBRICANT
- K040365 — COLOR CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM
- K040470 — TRIPTER X-1 COMPACT
- K040573 — NOBEL BIOCARE PERMANENT CENTRIC POST, MODELS 31234, 31235, 31236
- K040645 — DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEI
- K040653 — PARAMOUNT MINI GPS BILIARY STENT SYSTEM
- K040709 — PROTOS SOFTWARE
- K040785 — CONCERTO BIPOLAR NEEDLE ELECTRODE
- K040802 — HEMOSONIC 200HEMODYNAMIC MONITOR
- K040804 — .DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR
- K040808 — MINI L.E.D. OEM MODULE
- K040880 — MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3
Data sourced from openFDA. This site is unofficial and independent of the FDA.