FDA 510(k) clearances — page 961
clearances on record, most recent first.
Clearances — page 961
96,001–96,100 of 176,637- K970282 — MEDLINE CIRCUMCISION TRAY
- K970391 — QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES
- K970424 — EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST
- K970425 — EZ SURE URINE DIPSTICK PREGNANCY HOME TEST
- K970452 — ELECSYS CALCHECK CEA
- K970458 — ELECSYS CALCHECK PSA
- K970459 — ELECSYS CALCHECK CEA
- K960373 — BIOJECTOR 2000 MODEL 1B02000
- K963198 — PS-41 6M PATIENT SIMULATOR
- K963947 — EPILASER NORMAL MODE RUBY LASER
- K964220 — REPLACE TITANIUM IMPLANT SYSTEM
- K964966 — V-CATH
- K964997 — S-SCORT (2500)
- K965155 — LATEX EXAM GLOVES
- K970002 — STERILE WATER PUMP
- K970044 — AUROFLUID 22
- K970045 — SOLARO 33
- K970055 — KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY
- K970152 — BIOPSY TRAY
- K930683 — EZTEST-GAS
- K952567 — AUTOSTATTMII ANTI-DSDNA
- K954676 — NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS
- K961661 — OXIMETRIX 4 COMPUTER SYSTEM
- K962755 — STRYKER ENCORE STERILIZER
- K963257 — PERIPHERALLY INSERTED MEDLINE CATHETER
- K964046 — DENTSPLY PRECISION TORQUE SYSTEM
- K964589 — FLEXILOG 3000
- K964806 — MD-1835
- K964855 — EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD
- K964879 — PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 AND BATTERY ARTHROSCOPY PULSED IRRIGATOR SYSTEM
- K965023 — CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE
- K965030 — BRANNON ARTERIO-VENOUS PORTSYRINGE
- K965059 — CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243)
- K965176 — PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS
- K965229 — IMAGER TORQUE CATHETER
- K970047 — PHASED ARRAY TRANSDUCER - - PSK-20CT
- K970101 — JAMES ALEX SUNGLASSES
- K970105 — RIWO CUT-MORCELLATOR EXISTING OF KNIFE/CUTTING SLEEVE/PROTECTION SLEEVE/CLAW GRASPING FORCEPS
- K970125 — NOAH MONITORING ELECTRODE SYSTEM
- K962479 — SYNERMED ISE REAGENTS
- K963079 — CANON TX-10 TONOMETER
- K963318 — LEGIONELLA IGG/IGM ELISA TEST SYSTEM
- K963495 — IMZ 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEM
- K963522 — IMZ 2000 INTERLOCK 12/3 - SCREW
- K964014 — KENLOR H. PYLORI CONTROL SERUM
- K964168 — PROCEDURE SPECIFIC KITS
- K964698 — SAFETEX COMBINATION BLOOD (ALCOHOL, ETHYL) / URINE COLLECTION AND TRANSPORT KIT
- K964852 — RADIACARE ORAL WOUND RINSE
- K964860 — MARK 20 AND MARK 25 HAND ENGINE CONTROLLER
- K964871 — BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS
- K970336 — MMB CALIBRATOR
- K970393 — THYROID STIMULATING HORMONE METHOD
- K970527 — ABBOTT HCG SERUM CONTROLS
- K945117 — DELTA
- K953076 — TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM
- K960309 — AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION)
- K962534 — THERA-MIST NEBULIZER MODEL-P3000
- K963120 — RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM
- K963375 — CARDIACMONITOR
- K963576 — MOBILE MEDICAL MONITOR (M3(A))
- K963654 — QUIKSTRIP ONESTEP MARIJUANA (THC) TEST
- K964353 — CYBERLASE CO2 LASER SYSTEM
- K964820 — MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A
- K964834 — ISOCAM II (DUAL HEAD GAMMA CAMERA)
- K964863 — MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN
- K964876 — SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SET
- K964888 — HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II
- K964893 — HANSSON PIN SYSTEM
- K964930 — STRYKER SAPHENOUS VEIN HARVEST SCOPE
- K965056 — OSTEONICS SCREW HOLE PLUGS
- K965098 — INTRAMEDULLARY NAIL SYSTEM
- K965241 — BIPOLAR SUCTION COAGULATOR
- K970023 — MEDNEXT SURGICAL BUR
- K970040 — SPINE-TECH BONE HARVESTER
- K970337 — HA GLOBAL TAPER (GT) TAPERED HIP STEM
- K970351 — GLOBAL TAPER SPECTRON HIP STEMS
- K962666 — BEMISS JASON-STERILE,NON-STERILE,REINFORCED STERILE,AND REINFORCED NON-STERILE SURGICAL GOWN
- K964736 — BERGEN 610 BIPOLAR COAGULATOR
- K964845 — JINHUA LATEX EXAM GLOVE, POWDER FREE WITH PROTEIN LABELING
- K964847 — NINGBO YUJIANG LATEX EXAMINATION GLOVES, POWDER-FREE, WITH PROTEIN LABELING
- K964968 — MR EXTENSION SET (001)
- K965073 — 9 X 25MM STANDARD INTERFERNECE SCRE (S.I.S.) ACL SCREW
- K965216 — ARGI-SATIN OR OPTI0-STAR
- K970168 — 3M QUIKPLUS SYSTEM
- K970567 — SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS
- K961809 — SHE-LI TENS STIMULATOR MODEL SL-101 RX
- K961862 — MODELS IDA-2 PLUS AND IPT-1
- K963351 — LIFESHIELD BLUNT CANNULA
- K963406 — UHE COLLIMATOR (210591)
- K963662 — GALILEO EVOKED POTENTIALRE
- K964018 — PHACOILLUMINATOR - FIBEROPTIC SLEEVE
- K964112 — BERENSTEIN COIL
- K964181 — SPONGETRAC
- K964322 — VIPOR UNIT
- K964780 — BARD DIRECTOR GUIDEWIRE (000560)
- K964808 — SPETEMP
- K964813 — MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:
- K964990 — HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30)
- K965208 — POLYFIN EXTENSION SET, MODELS 126 AND 128
- K970039 — ENCORE ELECTROSURGICAL HANDCONTROL PENCIL (35001-001)
Data sourced from openFDA. This site is unofficial and independent of the FDA.