FDA 510(k) clearances — page 891
clearances on record, most recent first.
Clearances — page 891
89,001–89,100 of 176,637- K983641 — HOLLAND FEMORAL NAIL SYSTEM
- K983645 — SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
- K983685 — BONE BAND
- K983757 — SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR: 2991-01/15,2992-01/15, FOR SQUARE COLLAR:29992-01
- K983816 — NITRILE LATEX POWDERED EXAMINATION GLOVE
- K983825 — NITRILE LATEX POWDER FREE EXAMINATION GLOVE
- K983881 — COBRA EXTERNAL FIXATOR
- K983917 — THERATRON ELITE
- K983942 — INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP
- K983947 — AMERSE 2
- K984041 — QUADRANT UNIVERSAL LC
- K984042 — QUADRANT CORE LC
- K984043 — QUADRANT TOTAL ETCH
- K972991 — MONITOR ONE NDX
- K982764 — PREMIER CRYPTOSPORIDIUM
- K983116 — ELECTROSURGICAL INFLATABLE BASKET ELECTRODES
- K983128 — IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYY
- K983165 — OSTEO 4.0MM CANNULATED SCREW SYSTEM
- K983452 — NELSON RESURFACING HEAD
- K983583 — DEPUY ACROMED MOSS AND MOSS MIAMI SPINAL SYSTEMS
- K984071 — LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644
- K981171 — ERADIC-ALL
- K981881 — DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING
- K982212 — VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR, INSULATED 1.0MM TIP MODEL N301-010
- K983026 — PACEMAKER DATA PMD TRANSMITTER, MODEL CG-4000
- K983279 — ENDOCAM CAMERA SYSTEMS 5502 WITH ELECTRONIC CCD ENDOSCOPE
- K983317 — BARRON MICROKERATOME SYSTEM, MODEL B2000
- K983491 — DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER
- K983710 — 150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH
- K983870 — OSTEONICS RESTORATION HA HIP STEMS
- K971336 — CAIRD TECHNOLOGY SPIROMETER
- K974259 — VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE
- K974617 — PERIPHERAL VASCULAR DILATOR
- K983065 — MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM
- K983072 — AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201
- K983415 — DELIVERY SHEATH
- K983424 — ABBOTT ARCHEITECT TOTAL B-HCG
- K983503 — ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347
- K983847 — MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT
- K983871 — RITA MODEL 70 ELECTROSURGICAL PROBE
- K984129 — COAGULATION CONTROL LEVEL 1 (NORMAL)
- K984130 — COAGULATION CONTROL LEVEL 2 (ABNORMAL)
- K984131 — COAGULATION CONTROL LEVEL 3 (ABNORMAL)
- K981979 — UNISEAL GLOVES LOW PROTEIN POWDERED
- K982059 — ROTECNO 2000 SURGICAL GOWN
- K982170 — FLUIDSENSE FLUID DELIVERY SYSTEM
- K982218 — NITRILE POWDER-FREE UNISEAL GLOVES
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.