FDA 510(k) clearances — page 884
clearances on record, most recent first.
Clearances — page 884
88,301–88,400 of 175,890- K982241 — BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX
- K982453 — NON-STERILE E.P. LATEX EXAMINATION GLOVE
- K982716 — OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE, WITH PROTEIN CLAIM
- K982797 — BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB
- K982877 — MATANG POWDER-FREE LOW PROTEIN LATEX PATIENT EXAMINATION GLOVE
- K982898 — IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM
- K983172 — ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT
- K983240 — NEUTRALON PF POWDER FREE BROWN LATEX SURGICAL GLOVES
- K983244 — SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)
- K983490 — TERUMO VENOJECT,LUER ADAPTER
- K983515 — KLS INTRAORAL VERTICAL DISTRACTOR
- K983531 — POWDERED NITRILE MEDICAL EXAMINATION GLOVE, COLORED
- K983532 — POWDER FREE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVE, COLORED
- K983668 — MODIFICATION OF PQ1
- K983750 — DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER
- K983751 — QUADRANT UNICHEM
- K983869 — DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH
- K983975 — BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)
- K984034 — THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
- K983066 — FIRSTCLASS POWER TILT SEAT SYSTEM, MODEL S300
- K983108 — SUTURE WELDING SYSTEM AND KIT (SWK)
- K983681 — DOMINATOR
- K981365 — MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS
- K981651 — AB FLU OIA
- K981802 — ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003
- K981976 — ACUTRON MENTOR MODEL 961
- K982027 — MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY
- K982104 — ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500
- K982280 — CRYOPRO MAXI AND CRYOPRO MINI
- K982322 — SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEM
- K982348 — EBNA-1 IGM ELISA TEST SYSTEM
- K982350 — EA-D IGM ELISA TEST SYSTEM
- K982352 — VCA IGM ELISA TEST SYSTEM
- K982447 — PLUS BIPOLAR PROSTHESIS COCRMO
- K982711 — PREMIER GIARDIA
- K983004 — CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI
- K983008 — PERIPHERAL AVE STENT SYSTEM
- K983009 — BSM- BONE SUBSTITUTE MATERIAL
- K983020 — COMPACT KTP LASER
- K983042 — SWEEN WOUN'DRES
- K983045 — AMIELLE
- K983050 — PNEUMATIC CUTTER SYSTEM
- K983076 — MEDISYSTEMS TRANSDUCER PROTECTOR
- K983136 — DEPUY LUSTER STEM
- K983150 — COMPLETE BRAND LUBRICATING AND REWETTING DROPS
- K983234 — TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING
- K983249 — SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN
- K983259 — SYSTEM U3 FOR TRIMETHOPRIM/SULFAMETHOXAZOLE
- K983278 — OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AN NON-SIGHTED EYES)
- K983291 — SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
- K983301 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN
- K983384 — DCI ENDOSCOPE
- K983386 — BIOSTREP A-DIRECT STREP A ANTIGEN TEST
- K983419 — HOFFMANN II MIAMI POST
- K983440 — ABBOTT ARCHITECT TOTAL T4
- K983469 — PRECISET SERUM PROTEINS CALIBRATOR
- K983726 — GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
- K983788 — AARON COOLPAD SPLIT W/O CORD,AARON COOLPAD SPLIT WITH CORD, AARON COOLPAD W/O CORD, ARRON COOLPAD WITH CORD, MODELS ESRE
- K983859 — SPECTRUM SMALL FRY
- K983895 — IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT
- K983910 — ARTHRO-SURGIMAT-1500
- K983913 — MODIFICATION TO BIO-LOGIC SLEEPSCAN
- K983963 — DORNIER MEDILA H
- K983970 — IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5
- K984070 — ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05
- K984073 — ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05
- K981343 — ERCO-RIBBON
- K981357 — ERCO-VAC
- K981909 — BAXTER HEMOSTASIS VALVE INTRODUCERS
- K982416 — SHUN-THAI - SAFE-CONTACT, BOSTON MEDICAL LATEX EXAM GLOVE, SHUN-THAI LATEX EXMINATION GLOVE
- K982536 — PERFUSION CT (COMPUTED TOMOGRAPHY) SOFTWARE PACKAGE
- K982667 — MICROMEDICS NASAL SEPTAL BUTTON
- K982795 — PHILIPS BUCKY VISION
- K982956 — FLOWMATE II PLUS, MODEL #4000
- K982976 — ULTRASOUND WORKSTATION, UIWS-300A
- K982986 — TUBING BLOOD FLOW METER MODEL NUMBER HD-800
- K983325 — IN-PROBE II URODYNAMIC SYSTEM
- K983819 — INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN
- K983861 — DISTAFLO BYPASS GRAFT
- K984072 — ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-05
- K981249 — METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D
- K981379 — AURORA
- K981412 — M1145 (UPS1-1.25K-1G-MP) UPS
- K981768 — STEALTHSTATION TREATMENT GUIDANCE PLATFORM
- K982354 — SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M
- K982965 — ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES
- K982971 — ORATEC TAC-C, MONOPOLAR CAUTERY PROBE
- K982978 — MODEL 340GE-21C QUADRATURE BRAIN COIL
- K983006 — OSTEO 5.0MM CANNULATED SCREW SYSTEM
- K983035 — CUSTOM FLANGED ACETABULAR COMPONENT
- K983480 — BPOS-IVAD STABILIZER
- K983549 — QUADRANT ANTERIOR SHINE
- K983763 — SPECTRUM SPIRIT
- K983818 — MITEK FASTIN RC ANCHOR
- K983916 — V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER)
- K980278 — URESIL VASCU-FLO INFUSION CATHETER
- K981277 — PERIFORM
- K981530 — SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM
- K981820 — NEUROMAP
- K981975 — LATEX PATIENT EXAMINATION GLOVE POWDERFREE (BLUE COLOR) POLYMER COATED
Data sourced from openFDA. This site is unofficial and independent of the FDA.