FDA 510(k) clearances — page 805
clearances on record, most recent first.
Clearances — page 805
80,401–80,500 of 175,825- K010007 — ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP
- K010025 — ELECTRICATOR MODEL 26000
- K010140 — HRH-127 HEAD ARRAY COIL
- K010214 — FIRSTSAVE BIPHASIC MODEL #9200 AND 9210
- K001852 — PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE
- K002896 — ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING
- K002912 — VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073
- K003252 — COMPLETE BRAND MULTI-PURPOSE SOLUTION
- K003332 — MEDITHERM MED2000
- K003507 — MEDRELIEF
- K003651 — AURORA
- K003789 — SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR; SPECIALITY 56 UV TORIC (HEFILCON C) SOFT
- K003792 — STRYKER HEATED INSUFFLATOR TUBE SET
- K003856 — EZ-HCG URINE(PREGNANCY TEST)
- K003882 — NUCAMMA BI90
- K003912 — PHOSPHORUS REAGENT
- K003996 — OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR
- K004000 — OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT
- K010210 — CONTROL MODULE ALGORITHM ENHANCEMENT FOR THE MODEL S500-ST AND MODEL S400
- K010219 — CHALLENGER DIRECT COMPOSITE
- K010228 — GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
- K010374 — SONOSITE HAND-CARRIED ULTRASOUND SYSTEM
- K991259 — TE ME NA EPIDURAL CATHETER
- K003470 — EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870
- K003608 — SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY
- K003612 — MICROSPEED EC MOTORSYSTEM GD650/GD653
- K003659 — PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260
- K003700 — SYNTHES HAMSTRING LOOP
- K003870 — THROMBOREL S
- K003892 — TOTAL BILIRUBIN REAGENT
- K010208 — DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137
- DEN000008 — DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)
- K001916 — COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX
- K002045 — WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
- K002054 — X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1
- K002466 — ACTICOAT COMPOSITE DRESSING
- K002650 — VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726
- K003130 — REGUTHERM 952 THERMOGRAPHIC SYSTEM
- K003755 — MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES
- K003932 — BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY
- K003933 — BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY
- K010135 — MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4
- K010297 — SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE)
- K010336 — ADVANTAGE WINDOWS CT/PET FUSION
- K001147 — ENHANCED POLYETHYLENE KNEE PROSTHESES
- K002406 — MITEK 2GII MENISCAL REPAIR SYSTEM
- K002596 — GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09
- K002699 — PARIETEX COMPOSITE (PCO) MESH
- K003549 — CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS
- K003572 — DYONICS CONTROL RF SYSTEM
- K003599 — SMITH & NEPHEW SUTURE ANCHOR
- K003607 — ONYX-RAD TELEMEDICINE PACS
- K003650 — PERMLASTIC 3
- K003915 — ACCUFUSER; ACCUFUSER PLUS
- K003922 — NITRILE EXAMINATION GLOVES (POWERED)
- K003977 — DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET
- K004019 — ANA EIA DIAGNOSTIC TEST KIT
- K004032 — PERFECTA AND EXTEND
- K010069 — DURABOND NON-PRECIOUS CERAMIC ALLOY
- K010094 — A & I WHEELCHAIRS
- K010194 — COMFOR-CLINER
- K010211 — STERILE NITRILE POWDER-FREE EXAMINATION GLOVES
- K010243 — TRI-FIT FEMORAL STEM
- K001329 — INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET
- K002210 — SYNTRA DIALYZER, MODEL SYNTRA 120, 160
- K003419 — RCRP FLEX REAGENT CARTRIDGE
- K003566 — COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS
- K003591 — TENSCARE, MODEL TENS XL-2
- K003664 — DELFIA NEONATAL IRT KIT, MODEL A005-110
- K003667 — REVEAL PLUS INSERTABLE LOOP RECORDER
- K003695 — MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2.7-5.0MM MODEL MMD-4700 SERIES
- K003718 — TITANIUM CEMENT RESTRICTOR (TCR)
- K003782 — CONSTELLATION CATHETER, MODEL 8031
- K003795 — BIOLUCENT MAMMOGRAPHY CUSHION
- K003936 — PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING
- K004002 — IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600)
- K010012 — LC PROVIFILL
- K010030 — LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR
- K010075 — TEKNIQUE
- K010138 — PROFILE II ER
- K010187 — KIMAX, MODEL 1024
- K010212 — OFFSET TIBIAL TRAY
- K010237 — ELECSYS HCG+B CALCHECK
- K010246 — KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A
- K010342 — M2376A DEVICELINK SYSTEM, MODEL M2376A
- K010343 — BMR DENTAL IMPLANT SYSTEM, MODEL 3.3XX, EITHER HA OR TPS COATED, 3.308, 3.310,3.312, 3.314 3.316
- K001585 — BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR & BLUE VISIBILITY TINT, LATHE
- K002583 — TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM
- K003522 — SALUTE
- K003638 — MOJAVE CATARACT EXTRACTION SYSTEM
- K003833 — SPECIALTY 55 & MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENSES FOR DAILY WEAR
- K003853 — INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100
- K010004 — FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065
- K010137 — ORBITER II CCI/SPECT ORBITER II CCI/SPECT
- K010169 — BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER
- K010340 — MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI
- K002083 — LORENZ RESORBABLE DISTRACTOR SYSTEM
- K003510 — INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500
- K003514 — ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200
- K003515 — ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200
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