FDA 510(k) clearances — page 844
clearances on record, most recent first.
Clearances — page 844
84,301–84,400 of 175,890- K993455 — FLIPPER DETACHABLE EMBOLIZATION COIL
- K993460 — ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z43
- K993465 — DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE
- K993526 — SYNEA - LS LOW-SPEED HANDPIECE
- K993664 — SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES
- K993843 — MDI RF TEST
- K993954 — SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS
- K993971 — MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM
- K993973 — FUJI II LC CAPSULE
- K994029 — MDI SM TEST
- K994037 — THE 4.5MM DIAMETER BICON DENTAL IMPLANT
- K994043 — CORRECT TOUCH LATEX POWDERED EXAMINATION GLOVES
- K991391 — PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF
- K991962 — EIS DYNAMIC MEMORY STAPLES SYSTEM
- K992016 — AMUKIN D
- K992744 — MIDMARK M4*9 EASYCLAVE STEAM STERILIZER
- K992767 — BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR
- K992859 — ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE
- K992998 — AUTOMATED OPHTHALMICS SOFTIPS
- K993151 — RADID DRUG SCREEN 5-PANEL TEST
- K993411 — FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL FS-HMTR
- K993522 — AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT
- K993560 — FRIALIT-2 BONE PROFILER
- K993635 — MDI SM/RNP TEST
- K993636 — MDI SS-A TEST
- K993789 — CLINICAL BLOOD GAS MIXTURE
- K993897 — CERGOGOLD
- K994051 — HARDYDISK DOXYCYCLINE, 30MCG
- K994269 — TITAN RC TACK
- K990962 — FLOSENSE, MODEL 29-8010
- K992285 — SALTER AIRE COMPRESSOR
- K992455 — NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES
- K992911 — MAGSTIM RAPID
- K993039 — VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700)
- K993426 — ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z44
- K993429 — ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z40
- K993493 — THE AUTOTAC SYSTEM
- K994156 — MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BILIARY STENT, MODELS PQ294B, PQ394B
- K994272 — AUTOMATED CORE BIOPSY DEVICE
- K994326 — ASCENT KNEE SYSTEM
- K983866 — BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP
- K990803 — MEDISYSTEMS BUTTONHOLE NEEDLE SETS
- K991959 — PSI TITANIUM ANEURYSM CLIP
- K992101 — CRITERION 40 OR PM 40
- K993392 — BARD MEMOTHERM FLEXX BILIARY STENT
- K993400 — HDR CONTOUR TP TEMPLATE AND IMPLANT ACCESSORIES
- K993738 — DISPOS-A-SCOPE
- K993778 — HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00
- K993892 — DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE BALLOON, MODEL 007124-25,007144-45
- K993948 — SIS WOUND DRESSING II
- K993210 — ACCESS HYBRITECH FREE PSA QC, MODEL 37219
- K993376 — ENSTYLET MODELS EC0010, EC0020
- K993407 — OHMEDA MEDICAL OMNIBED
- K993585 — VARELISA TPO ANTIBODIES, MODEL 12348/12396
- K993949 — SOLO-CARE BRAND HARD SOLUTION
- K994253 — VACLOK SYRINGE
- K991647 — TFX MEDICAL INTRODUCER KIT
- K993361 — TUBING EXTENSION SET
- K993463 — INTRAVASCULAR ADMINISTRATION SET
- K993672 — REBAR MICRO CATHETER, MODELS 105-5080, 105-5086
- K994252 — INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE
- K993461 — QUEST INTERSEGMENTAL ROLLER TRACTION TABLE
- K993556 — LIQUIBAND DENTAL
- K993850 — URINALYSIS REAGENT STRIPS (10 PARAMETERS)
- K993873 — ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD
- K993919 — DYNATRON 900
- K994111 — CELSITE, MODELS ST401L, ST405L
- K994251 — KETAC-MOLAR QUICK
- K993232 — WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
- K993330 — THERMOCHEM-HT SYSTEM
- K993969 — SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION
- K994186 — DISETRONIC D-TRON INSULIN INFUSION PUMP
- K994219 — AT HOME DRUG TEST, MODEL 9073
- K994220 — AT HOME DRUG TEST, MODEL 9078
- K994233 — AT HOME DRUG TEST, MODEL 9068
- K994234 — AT HOME DRUG TEST, MODEL 9083
- K994236 — AT HOME DRUG TEST, MODEL 9133
- K994237 — AT HOME DRUG TEST, MODEL 9063
- K992148 — HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT
- K992927 — STEALTHSTATION TREATMENT GUIDANCE PLATFORM
- K993030 — MODIFICATION TO ISOLA SPINAL SYSTEM
- K993283 — OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C
- K993288 — SULZER CARBOMEDICS CARDIOFIX PERICARDIUM
- K993338 — INTEGRATED DIGITAL MEDICAL RECORD (IDMR)
- K993450 — LATEX SURGICAL GLOVES, PRE-POWDERED
- K993529 — POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K993542 — ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL V46
- K993562 — POWDER FREE LATEX STERILE SURGICAL GLOVES
- K993575 — RESOLVE QUICKANCHOR
- K993621 — HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC
- K993693 — INVIGRA
- K993862 — MODUS SAGITTAL SPLIT PLATE
- K994197 — DISENTRONIC PENFINE INJECTION PEN NEEDLE
- K991441 — CADENCE DOPPLER ULTRASOUND SYSTEM
- K991541 — A-MED VASCULAR CANNULA, MODELS V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44
- K991562 — PASCAL MEDICAL AB MENIETT 20
- K993591 — BLADEWORKS DISPOSABLE ALK TUBING
- K993643 — NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100
- K993650 — URETERAL ACCESS SHEATH SET - NEW MODELS
- K993761 — CARDIOVASCULAR MEASUREMENT SYSTEM - VIEW
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