FDA 510(k) clearances — page 903
clearances on record, most recent first.
Clearances — page 903
90,201–90,300 of 175,890- K974141 — PLUS REUSABLE RESUSCITATOR
- K974571 — SOLUTION ADMINISTRATION SET WITH CAPPED LUER ACTIVATED VALVE
- K974695 — COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL)
- K980401 — FLEXIBLE FIBERSCOPES AND ACCESSORIES
- K980673 — SPYROSORB FOAM ISLAND WOUND DRESSING
- K980676 — SPIGAL NEEDLE
- K981091 — NEOCOLLOID, ORTHOPRINT
- K972595 — ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER
- K973615 — SKINGARD TPF/AOSSTEX TPF/SENSIFREE/ESSENTIAL TPF/AMERIGLO TPF LATEX EXAMINATION GLOVES
- K974513 — PINPOINT
- K974536 — PHOTODERM HR SYSTEM
- K974540 — SIS HERNIA REPAIR DEVICE
- K974830 — ULTRA BILI LIGHT
- K980125 — REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETER
- K980319 — DUREX ULTRA COMFORT
- K980563 — SKAR-KARE SHEET
- K980636 — FIBER OPTIC ENDOILLUMINATION PROBE
- K980665 — REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS
- K980685 — MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS
- K980750 — RADIOCAMERAS PATIENT POSITIONING SYSTEM
- K980794 — DUAL LOCK HIP STEM
- K980837 — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS
- K980841 — RCI FIXATION SCREWS
- K980842 — COPPER TONGUE SCRAPER
- K980861 — DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL
- K980862 — TITANIUM SPINAL ROD SYSTEM
- K980866 — MEDI-DX 7000 CPT WITH AMREX ELECTRODES
- K980880 — SENSI-DERM LATEX SURGICAL GLOVES (POWDERED)
- K980981 — OMEGA HA COATED TOTAL HIP SYSTEM
- K981045 — EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS
- K981070 — 20-HOLE ADAPTATION PLATE
- K981156 — DYONICS INTELIJET INFLOW/OUTFLOW CANNULA
- K981188 — ELECTROSURGICAL CAUTERY PROBES
- K981245 — ALKALINE PHOSPHATASE (ALKP)
- K981279 — TIBC
- K981404 — FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500
- K981407 — OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER
- K981423 — AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000
- K981452 — OSTEONICS LONG ARM CONTAINMENT RING
- K981458 — KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110
- K981460 — CUB DIS II DPOAE MEASUREMENT SYSTEM
- K980018 — CRISTOBAL
- K980292 — CATARACT LIQUEFRACTURE DEVICE
- K980295 — OPHTHAVISION IMAGING SYSTEM
- K980604 — SMITH & NEPHEW DYONICS ENDOSCOPES AND ACCESSORIES
- K980625 — SIEMENS MULTIVIEW WORKSTATION ENHANCED WITH DIAGNOSTIC STATEMENTS (REST ECG)
- K980656 — PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236
- K980658 — PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234
- K980797 — PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR
- K981116 — SOVEREIGN CATARACT EXTRACTION SYSTEM
- K981169 — RONDEX CPR ISO-SHIELD
- K970726 — VAPOCIDE
- K972114 — OLYMPUS SONOSURG SYSTEM
- K973789 — NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC
- K973892 — RUSCH BLAKEMORE TUBE - 4 LUMEN (MINNESOTA TYPE)
- K974015 — ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL
- K974080 — CRITIKON SOFT BLOOD PRESSURE CUFF
- K974534 — MICRO-PLATE COTININE EIA
- K980354 — CRYPTOSPORIDIUM TEST
- K980379 — PROWESS PRO-SIM
- K980584 — ATLASPLAN
- K980609 — SEGMENTAL DEFECT REPLACEMENT SYSTEM
- K980610 — DEXON RAPID (DEXON R)
- K980754 — CIR LATEX EXAMINATION GLOVES, NON-STERILE, POWDERED, WITH PROTEIN LABELING CLAIM OF <=200 UG/G
- K980773 — ETEST GREPAFLOXACIN
- K980955 — PASCO MIC AND MIC/ID PANELS
- K981001 — ORION VESTA DENTAL ALLOY
- K981002 — ORION WX DENTAL ALLOY
- K981020 — ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM
- K981085 — GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM
- K981232 — CA
- K981338 — LD-1
- K981347 — SMARTTEX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM
- K981348 — SMARTTEX PREPOWDERED LATEX EXAMINATION GLOVES
- K981349 — SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES
- K981401 — BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS
- K971077 — COVERTIP SAFETY SYRINGE
- K980014 — THE SYSTEM 2S STEAM STERILIZER
- K980210 — VARIOUS SURGICAL OR PATIENT DRAPES
- K980575 — SITESEER ANGIOGRAPHIC CATHETER
- K980620 — DENTATUS MTI MODULAR TRANSITIONAL IMPLANTS AND PROSTHETIC SYSTEM
- K980647 — EYE IRRIGATOR MODEL #2020
- K980732 — 3M CDI QUICK-CELLS WITH HEPARIN TREATMENT
- K980792 — CU-100A LIGHT CURE UNIT
- K980793 — Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT
- K981000 — CARRARA PORCELAIN AND CARRARA VINCENT PORCELAIN
- K981073 — MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK
- K981179 — LOVYTEX POWDER-FREE NITRILE EXAMINATION GLOVES
- K971421 — BARD ISOFLOW BLOOD PUMP
- K973920 — STARDUST
- K974234 — MICRO-PLATE COTININE EIA
- K974584 — FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS
- K980935 — CAPIOX SX HARDSHELL RESERVOIR
- K981239 — DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS
- K971207 — SOFTLIGHT Q-SWITCHED (ND:YAG) LASER
- K971374 — GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE
- K974008 — PFLEIDERER'S INTRATYMPANIC CATHETER
- K974491 — ACCU-CHEK A1C HEMOGLOBIN TEST
- K980547 — NIDEK PRIMA MODEL GYC-1500/2000
- K980548 — DURA-PATCH MODEL DP-XXX
Data sourced from openFDA. This site is unofficial and independent of the FDA.