FDA 510(k) clearances — page 842
clearances on record, most recent first.
Clearances — page 842
84,101–84,200 of 176,637- 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
- K000595 — DIMENSION PENTA L
- K000629 — FLEXTIME
- K000725 — HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
- K000872 — DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
- K000908 — SKYLIGHT IMAGING SYSTEM
- K000951 — LUXAFORM
- K992781 — ARCHITECH AFP MASTERCHECK, MODEL 6C01-05
- K000028 — RENAFLO II HF 2000 HEMOFILTER
- K000029 — STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
- K000049 — SUNI MAX
- K000113 — PROVEN KNEE SYSTEM
- K000414 — MEDISUL DISPOSABLE VAGINAL SPECULUM
- K994065 — MS-ONE, MODEL MS-1
- K000027 — INSUFFLATION NEEDLE, MODEL R65-933
- K000080 — ASNIS III CANNULATED SCREW SYSTEM
- K000262 — BOHN FEMORAL COMPONENT
- K000459 — URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A
- K000662 — RANDOX FERRITIN
- K000797 — OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01
- K000858 — WEHRS INCUS-STAPES
- K992451 — RAPIDONE- BARBITURATE TEST
- K992720 — RAPIDONE- BENZODIAZEPINE TEST
- K992918 — STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I
- K993208 — STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I
- K993925 — WAKO L-TYPE UN TEST
- K000026 — APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER
- K000202 — CORTEK LAPAROSCOPES
- K000305 — HARDYDISK, CEFOXITIN, 30MCG
- K000422 — S57D DIGITAL OPERATING ROOM CAMERA
- K000423 — S52D DIGITAL VIDEO LAPAROSCOPE
- K000424 — S51D DIGITAL ENDOSCOPY CAMERA
- K000454 — DIMEX 2
- K000483 — RANDOX ALBUMIN
- K000715 — ENVOY AND VISTA BRITE TIP
- K000722 — UNIPOLAR NEEDLES
- K000731 — MODIFICATION TO RTA RETINAL THICKNESS ANALYZER
- K991383 — HYDROCISION DEBDRIDEMENT SYSTEM
- K992392 — RTLX
- K993412 — BITX PROBES
- K993512 — DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER
- K993552 — ISOSEED PD-103
- K000018 — BRANEMARK NOVUM
- K000032 — LEVEEN NEEDLE ELECTRODE
- K000037 — MONOFILAMENT BIOSYN SUTURE
- K000046 — KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS)
- K000369 — VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5; VACUFLOW+ WITH HOLDER BLOOD COLLECTION SET, MODEL 82021/3/5 WITH HOLDER
- K000588 — DIMENSION GARANT L, DIMENSION GARANT L QUICK
- K000591 — DIMENSION PENTA H, DIMENSION PENTA H QUICK
- K000697 — MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS
- K000717 — SMITH & NEPHEW SUTURELOK, MODEL 7207321
- K984360 — COLORADO II SPINAL SYSTEM
- K993019 — PACIFIC SURGICAL PATTIES
- K993041 — OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.