FDA 510(k) clearances — page 1010
clearances on record, most recent first.
Clearances — page 1010
100,901–101,000 of 176,637- K955434 — ACCESS FOLATE ASSAY (MODIFICATION)
- K955438 — URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION)
- K955441 — ZONG RONG SUNGLASSES
- K955695 — PLASTIC FRAME, METAL FRAME, OPTICAL
- K943547 — PHENYLALANINE TEST KIT
- K944544 — ABSORBABLE BONE SCREW
- K945212 — MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/
- K950518 — MIELE G 7781 DENTAL THERMAL DISINFECTOR
- K952294 — NEURONET
- K952819 — ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC)
- K953250 — SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE
- K953456 — E-Z FLEX
- K953529 — STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM
- K953583 — LUBRICATED CONDOM
- K953586 — VARELISA PR3-ANCA
- K953587 — VARELISA MPO-ANCA
- K953670 — ACCUSCAN MODEL C CO2 LASER SCANNER
- K953746 — ARROW HIGH FLOW FLUID ADMINSITRATION SET W/BLOOD FILTER & EXTENSION SET
- K953754 — GLOBAL HEALTHCARE FACE MASK
- K953977 — PRIMALOC CEMENTLESS HIP SYSTEM
- K954153 — ARISTA VINYL EXAMINATION GLOVES
- K954186 — SLED UNICOMPARTMENT KNEE SYSTEM
- K954285 — CONTOUR FLEX VALVES (REGULAR & SMALL)
- K954555 — VERSA-FX FEMORAL FIXATION SYSTEM
- K954684 — DEPUY ANATOMIC MODULAR KNEE (AMK) CONGRUENCY POSTERIOR STABILIZED TIBIAL INSERT
- K954990 — DENTAL DAM
- K955000 — REMOTE VIEWING SYSTEM MEDICAL IMAGE DISPLAY MODULE
- K955007 — APPLIED OPTRONICS MODEL AOC 5060 SURGFICAL DIODE LASER SYSTEM
- K955014 — APPLIED OPTRONICS MODEL AOC 25 SURGICAL DIODE
- K955120 — HAND-HELD RETRACTOR, DISSECTOR & DISSECTOR
- K955253 — SHIMADZU WHOLE BODY X-RAY SCANNER SCT-7000TH
- K955254 — SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TC
- K955320 — PROTEC COTTON PADDING BANDAGE
- K955433 — DURALASTIC SILICONE TUBING
- K955751 — PRIME FEMORAL CEMENT PLUG
- K955861 — MICROQUARTZ MEDICAL TYPE B SIDE-FIRING LASER FIBER
- K945068 — OMEGA CARES SYSTEM
- K945303 — ARTHREX BIOABSORBABLE INTERFERENCE SCREW
- K950999 — KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS
- K951044 — SYSTEM ONE HYPERBARIC CHAMBER
- K953748 — TECHNOFIL
- K954016 — VIDEOSCOPE W/IRRIGATION SHEATH
- K954195 — INDIGO PORTABLE LASER SYSTEM, INDDIGO FIBEROPTICS
- K954352 — BITE BLOCK
- K954756 — FIXANO I.F.O (INTERLOCKING FLEXIBLE OSTEOSYNTHESIS) SYSTEM
- K954757 — FIXANO D.D.S. (DOUBLE SLIDING SCREW)
- K954770 — CENTRA-LINE GRAPPLE, VARIFIX SYSTEM
- K954801 — TECHFIL
- K954803 — BLOOD GAS MIXTURES
- K954804 — LUNG DIFFUSION MIXTURES
- K954939 — MEDPOR OCULAR SCREW & ACCESSORIES
- K954942 — NATRACAREN APPLICATOR TAMPON
- K954954 — CEEGRAPH TRAVELER AMBULATORY EEG RECORDER
- K954992 — ROCHE COBAS INTEGRA REAGENT CASSETTES
- K955066 — OLYMPUS FG SERIES GRASPING FORCEPS
- K955284 — OPUS TROPONIN I
- K955658 — LACERATION TRAY
- K946207 — CONQUEROR, RUMBA AND TEMPTATION
- K946215 — CARDIOLIPIN G EIA TEST SYSTEM
- K946216 — CARDIOLIPIN A EIA TEST SYSTEM
- K946217 — CARDIOLIPIN M EIA TEST SYSTEM
- K952557 — TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS
- K953500 — HEMO-BARRIER
- K954119 — MIRACLE EAR MIRAGE
- K954276 — STEALTHSTATION
- K954332 — RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
- K954749 — MALLINCKRODT SHILEY 15MM CAP
- K954838 — EZ FIX
- K954887 — STERILE WATER O.9% STERILE SALINE
- K954911 — OMEGA ULTRASCAN
- K954928 — PORTABLE REVERSE OSMOSIS MACHINE
- K954972 — LYELL SOUND
- K954997 — CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT
- K955052 — OLYMPUS FD-1/2-1 HOT BIOPSY FORCEPS
- K955065 — OLYMPUS FB SERIES BIOPSY FORCEPS
- K955149 — MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL
- K955151 — MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR
- K955163 — DISSECTION PROBE
- K955184 — ACCULUPE
- K955285 — GALLOY
- K955354 — ALTERNATIVE STERILIZATION PROCESS
- K955435 — ACCESS TOTAL T3 ASSAY (MODIFICATION)
- K955436 — ACCESS VITAMIN B12 ASSAY (MODIFICATION)
- K955494 — GORE-TEX DUALMESH BIOMATERIAL WITH HOLES
- K955498 — CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05
- K955521 — ALPHA-DENT COPAL CAVITY VARNISH
- K955562 — INNOFLUOR PHENYTOIN ASSAY SYSTEM
- K955567 — INNOFLUOR THEOPHYLLINE ASSAY SYSTEM
- K955810 — U-TEX
- K923693 — KLORMAN
- K940832 — I.V. ADMINISTRATION SET CONNECTING DEVICE
- K952515 — COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY
- K952961 — BODY FLUID BARRIER KIT
- K953068 — OXBORO-MEDICAL FOAM INSTRUMENT HOLDER
- K953335 — MICRO THERAPEUTICS VARIABLE INFUSION LENGTH CATHETER
- K954454 — NIOMED SURGICAL HOOD
- K954455 — NIOMED BOUFFANT CAPS
- K954744 — ZCH ALPHA SYSTEM
- K954983 — EXTENSION SET WITH CHECK VALVE
- K954984 — MINIBORE STOPCOCK SET
Data sourced from openFDA. This site is unofficial and independent of the FDA.