FDA 510(k) clearances — page 953
clearances on record, most recent first.
Clearances — page 953
95,201–95,300 of 175,890- K965040 — INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL
- K965043 — 3M 1830 FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK AND 3M 1830FS FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK WITH FACE SHIE
- K965115 — ROUND WINDOW CATH
- K965146 — FLAT CLOSED WOUND DRAIN WITH TROCAR
- K965240 — SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L
- K970100 — TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL
- K970286 — PRESBYTERIAN LINEN SERVICES SURGICAL PACKS
- K970357 — EPISCREEN
- K970360 — MITEK SUTURE RETROGRADER
- K970385 — SPARFLOZACIN, 5 MCG, SENSI-DISC
- K970387 — HUMAN CHORIONIC GONADOTROPIN METHOD
- K970477 — HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT
- K970666 — LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL
- K944180 — MODEL 700
- K961892 — SPECKTIN-LA TEST SET
- K962446 — SHARPLAN RUBY LASER SYSTEM
- K962545 — DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE
- K962578 — HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY
- K962719 — HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY
- K962720 — HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY
- K962722 — HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY
- K962727 — HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY
- K962728 — HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY
- K962729 — HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY
- K962730 — HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY
- K962731 — HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY
- K964528 — (LENSES) BENZ-G 3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE TINT
- K964924 — OMEGA TOTAL HIP SYSTEM FOR USE WITHOUT BONE CEMENT (LINE EXTENSION)
- K951632 — ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)
- K954488 — ROLLER ELECTRODE
- K960072 — SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX
- K962327 — SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE
- K962547 — CARDIOSERV P
- K962781 — COROMETRICS MODEL 510 AND 511 MONITOR
- K963974 — IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN
- K964066 — DUAL SLIM PORT IMPLANTED PORT (0654970/0654940)
- K964385 — ELIAS ANA-HEP-2
- K964609 — ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE
- K964843 — IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT
- K964890 — ANATOM 2000
- K964939 — THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS
- K964962 — SENTURA SURGICAL GLOVES
- K964967 — BIOCOR 200 HIGH PERFORMANCEOXYGENATOR
- K964980 — ULTREX POWDER-FREE SURGICAL GLOVES/ULTREX POWDER-FREE SURGICAL GLOVES WITH LOW PROTEIN CLAIM
- K964988 — COULTER AC.T SERIES ANALYZER
- K965055 — IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES
- K965070 — SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M.
- K965078 — 2.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVIEW GRASPING FORCEPS
- K965108 — SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT
- K965194 — MEDICOM, TENS ELECTRODES
- K970087 — CR PERFECT
- K970124 — LIPASE REAGENT SET (COLIPASE METHOD)
- K970212 — LEVOFLOXACIN, 5MCG, SENSI-DISC
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.