FDA 510(k) clearances — page 834
clearances on record, most recent first.
Clearances — page 834
83,301–83,400 of 175,890- K000098 — SOFTLINE SPRING CLIP
- K000105 — MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM),
- K000125 — JET PORT PLUS CATHETER SYSTEM
- K000127 — KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10
- K000275 — DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA
- K000314 — INCENTIVE SPIROMETER
- K000337 — MTP DISPOSABLE TROCAR VALVES
- K000390 — VITAL SHIELD GOLD POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
- K000391 — VITAL SHIELD GOLD POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K000426 — VIP- VARIABLE INTENSITY POLYMERIZER
- K000555 — TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN & POWDER LABEL CLAIM CONTAINS 70MGM OR LESS O
- K000584 — POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K000670 — NITRILE EXAM GLOVE, POWDER FREE, BLUE
- K000688 — UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES
- K000740 — ASAHI STERILE ACUPUNCTURE NEEDLE TYPE S
- K000793 — 1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER
- K001008 — TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921
- K991677 — REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE)
- K992553 — IQ CHAMBERS
- K993116 — A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER
- K994099 — VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED
- K000148 — RGP MULTI-PURPOSE SOLUTION ID 100136
- K000198 — CORTEK ARTHROSCOPE
- K000221 — SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM
- K000345 — MULTI PURPOSE FLEX ARRAY COIL : MODEL 235 SERIES
- K000350 — SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE TEST
- K000415 — OIS-2500 DIAGNOSTIC ULTRASOUND SYSTEM
- K000441 — BODYGUARD
- K000471 — FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT
- K000768 — WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
- K000777 — SAMPLOK
- K000878 — HONIGUM
- K972610 — POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER MODEL 3030C, LF140 CATHETER MODEL 3040C
- K990830 — MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS
- K000135 — PRO.DUCT CATHETER, MODEL CTH03
- K000151 — PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE
- K000192 — E3 MICROPROB SERIES OF LASERS AND ACCESSORIES
- K000194 — DIGITAL INFLECTION RIGIDOMETER (DIR)
- K000321 — HEMISPHERE MODULAR CUP SYSTEM
- K000410 — SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS
- K000652 — BETEL POWDER FREE LATEX EXAM GLOVES, CHLORINATED, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
- K000794 — MODIFICATION TO MARSPO2, MODEL 2001
- K000843 — MODIFICATION TO JMS APHERESIS NEEDLE
- K000845 — MODIFICATION TO JMS A.V. FISTULA NEEDLE SET
- K000854 — VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, VIRIDIA TELEMETRY SYSTEM TRANSMITTER
- K000979 — REDI-SCREEN
- K991458 — MECA WRIST BLOOD PRESSURE METER, MODEL EW243 AND MODEL EW254
- K993272 — PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM
- K993305 — TRANSLUMINAL BALLOON DILATATION CATHETER
- K993448 — STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
- K993616 — CARDIO-CARD INTERPRETATION SYSTEM I
- K993867 — BAYER ADVIA IMS SYSTEM
- K994062 — HMS NEUROMUSCULAR STIMULATOR
- K994288 — 5.0MM SPINAL SCREWS
- K000061 — MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT
- K000177 — RENEGADE HI-FLO MICROCATHETER
- K000261 — HARDYDISK, PIPERACILLIN/TAZOBACTAM, 110MCG
- K000268 — HARDYDISK, AMPICILLIN, 10MCG
- K000271 — HARDYDISK, SULFA/TRIMETH
- K000272 — HARDYDISK, NITROFURANTOIN
- K000273 — SCREENERS OPIATES TEST DRUGSCREEN DIP OPIATES TEST
- K000440 — HARDYDISK CEFTRIAXONE 30MCG
- K000449 — SCREENERS BENZODIAZEPINE (BZD) TEST, DRUG SCREEN DIP BENZODIAZEPINE (BZD) TEST
- K000509 — HARDYDISK, VANCOMYCIN 30MCG
- K000524 — HARDYDISK, CEFOTAXIME 30MCG
- K000525 — HARDYDISK OFLOXACIN 5MCG
- K000527 — ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094
- K000528 — ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119
- K000746 — FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX
- K000828 — HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE
- K000934 — MDI SCL-70 TEST
- K000935 — KFA-63 KNEE AND FOOT ARRAY
- K992173 — SIPHONGUARD CSF CONTROL DEVICE
- K993414 — PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2
- K993923 — ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM
- K994165 — ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595
- K000213 — JELDENT BASIC LINE
- K000461 — URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A
- K000462 — URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A
- K000532 — JEL 15
- K000748 — TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
- K000753 — CORDIS 13F CATHETER SHEATH INTRODUCER
- K000763 — PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051
- K000764 — PEDIATRIC FIXATION RODS
- K000822 — AGILENTCOMPONENT MONITORING SYSTEM, AGILENT 24/26, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR
- K000941 — STERLTECH WATER PURIFIER
- K982556 — LEVEEN NEEDLE ELECTRODE
- K983657 — OSTEONICS SERIES 7000 AD TIBIAL TRAY
- K991060 — ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000
- K992154 — BICON-PLUS ACETABULAR COMPONENTS
- K993027 — ESKA MODULAR HIP SYSTEM
- K000051 — ACTICOAT FOAM DRESSING
- K000235 — INSYTE CATHETER, INSYTE AUTOGUARD CATHETER
- K000323 — NITRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDER FREE, NON STERILE
- K000329 — NITRILE PATIENT EXAMINATION GLOVE POWDER FREE, NON STERILE
- K000330 — NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR), POWDER FREE, NON STERILE
- K000375 — RANDOX CALCIUM
- K000466 — URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A
- K000489 — ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST
- K000534 — COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II
Data sourced from openFDA. This site is unofficial and independent of the FDA.