FDA 510(k) clearances — page 1275
clearances on record, most recent first.
Clearances — page 1275
127,401–127,500 of 175,890- K900979 — GAS SAMPLING NASAL CANNULA
- K901069 — COMPUTERIZED FUNCTIONAL TESTING GAIT SYSTEM
- K894610 — CUSTOM TRAYS, KITS
- K894948 — PLATELIA TOXO IGM KIT
- K895195 — CHEMO-TOUCH
- K895981 — WIDEX HEARING AID MODELS ES9T AND ES9H
- K895982 — WIDEX HEARING AID MODEL ES 10 ASP T
- K896174 — PROTEIN S ANTIGEN ROCKET EID KIT, CAT. NO. 5359
- K897096 — MODEL 404A I.V. INFUSION PUMP ANALYZER
- K897144 — THYROXIN(T4) ENZYME IMMUNOASSAY TEST KIT
- K897175 — OLYMPUS DIRECT BILIRUBIN
- K900015 — NON-ELECTRIC BIOPSY FORCEPS
- K900022 — BJ STAR ALL SILICONE FOLEY BALLOON CATHETER
- K900065 — NON-ELECTRIC BIOPSY FORCEPS
- K900104 — TCPM II TOURNIQUET CUFF PRESSURE MONITOR
- K900309 — VENOJECT II BLOOD COLLECTION TUBES
- K900395 — ORTHOKROME* FACTOR VIII
- K900396 — ORTHOKROME* HEPARIN
- K900397 — ORTHOKROME* ANTIPLASMIN
- K900398 — ORTHOKROME* PROTEIN C
- K900399 — ORTHOKROME* PLASMINOGEN
- K900400 — ORTHOKROME* ANTITHROMBIN
- K900574 — ABIOMED BODY LEAD ANALYZER MODEL 200/20
- K900594 — ANESTHESIA BREATHING CIRCUIT
- K900754 — RESPIREX 2
- K900763 — ENZYMUN TEST(R) FSH
- K900821 — AUTOSCEPTOR-GRAM-POSITIVE MIC PANEL READING
- K901026 — MJ PERCUSSOR(TM)
- K893004 — HEARING AID (ALL-IN-THE-EAR)
- K895017 — SORBA MODEL CIC-1000, COMP. IMPEDANCE CARDIOGRAPH
- K896048 — S-ROM/NOILES MARK 3
- K896588 — ONCOPROBE II SYSTEM
- K896766 — TD-28 DISPOSABLE ELECTRODE
- K897020 — ALL-BOND DENTIN BONDING SYSTEM
- K897027 — TEETHMATE-A
- K897101 — DISPOSABLE PROPHY ANGLE AND ACCESSORIES
- K897116 — OPTIMA MPT MODEL 5281E AND MODEL 5282E
- K897184 — 3F AND 4F IRRIGATION EMBOLECTOMY CATHETERS
- K900050 — MIRACLE EAR MODEL CK IN-THE-EAR HEARING AID
- K900191 — MCT COMPOSITE CHAIR
- K900296 — SAFETEX/SUNTEX STERILE SURGICAL LATEX GLOVES
- K900452 — QUATTRO CATHETER
- K900461 — OPUS MODEL 4021, VVI, 5MM UNIPOLAR
- K900593 — TECHNICON H*2(TM) SYSTEM
- K900692 — DAHLBERG MODEL JMS IN-THE-EAR HEARING INSTRUMENT
- K901022 — POWERED INFLATABLE TUBE MASSAGER, SPORT-MED
- K894300 — SUBMERSIBLE REVERSE OSMOSIS WATER PURIFICATION SYS
- K895297 — AUTOTRANSFUSION RESERVIOR MODEL 7900 MODIFICATION
- K895468 — ORGENICS IMMUNOCOMB(TM) CHLAMYDIA TRACHOMATIS IGG
- K895507 — LINK GIEBEL BLADE PLATE SYSTEM
- K895547 — GRANDCOR/CARDIOLINE ECT STRESS TESTING
- K895824 — L.T.C. ENTERAL BAG ADMINISTRATION SET W/PUMP SET
- K895972 — CURITY(R) PERCUTANEOUS CATHETERS
- K896559 — INFANT FEEDING TUBE
- K896621 — L.T.C. REPLACEMENT GASTROSTOMY TUBE
- K896950 — CORE BUILD UP COMPOSITE
- K896958 — ESCORT NON-INVASIVE BLOOD PRESSURE OPTION
- K897004 — NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEM
- K897115 — ANGIOREX C/N (ANGIOGRAPHIC X-RAY SYSTEM)
- K897126 — ATRIUM 2050 CHEST DRAIN BLOOD RECOVERY SYSTEM
- K897127 — ATRIUM 2052 CHEST DRAIN, DUAL COLLECTION BLOOD
- K897171 — DISPOSABLE CO2 ABSORBER/E
- K900195 — MODIFIED GORE-TEX SURGICAL TAPE
- K900517 — RAPID NF SYSTEM
- K900553 — CONSTANT CURRENT STIMULATOR MODEL 022101
- K900606 — 'CONDUCTOR' DISPOSABLE TENS ELECTRODE
- K900660 — TOMOSCAN STEREOTAXIS SIMULATION SOFTWARE
- K900969 — REMOTE CONTROL SWITCH
- K900997 — K-STERILE TENS ELECTRODES
- K901028 — ENVIRONMENTAL CONTROL UNIT MODEL 7000
- K901029 — YES-NO VOICE BOX 7011
- K901030 — ROTARY COMMUNICATION SCANNER MODEL 7010
- K884389 — MODIFIED 225/SIMV VOLUME VENTILATOR
- K894650 — Q-PORT SYSTEM KIT
- K895159 — INTRAVASCULAR IMAGING SYSTEM
- K895915 — MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM
- K896923 — INTERTECH/INSPIRON (R) MEDICATION NEBULIZER KIT
- K897059 — HOOD SPEAKING VALVE
- K897107 — POLY G PHYSIOLOGICAL DATA RECORDER
- K897186 — LASER IMAGING WORK STATION
- K900090 — NIKON MULTI-SPORT SUNGLASSES
- K900466 — MOBILIMB W1 WRIST CPM UNIT
- K900506 — MODIFIED COATRON II AND COATRON JR.
- K900795 — MOBILIMB L4 LOWER LIMB CPM UNIT
- K900891 — MODIFIED AML + ACETABULAR CUP PROSTHESIS
- K893606 — PATIENT EXAMINATION GLOVES
- K894629 — NICOLET BEAM II SYSTEM
- K895328 — MAGNETIC RESONANCE SYSTEM MODEL BMT-1100
- K895479 — THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM
- K895781 — ANSELL E.P. EXTRA-PROTECTION EXAMINATION GLOVES
- K896146 — BIOPSY FORCEPS, (NON-RIGID)
- K896359 — AG-820PA FI02 MODULE
- K896982 — AIA-PACK T4
- K896984 — PARI I.S.-2
- K897001 — TOSOH AIA-PACK T3
- K897071 — ROCHE STANDARDS FOR THE COBAS ISE MODULE
- K897138 — AFFINITY(TM) HTSH(TM)
- K897159 — COULTER TRIGLYCERIDES GPO REAGENT
- K897160 — COULTER GLUCOSE REAGENT
- K897163 — COULTER ALT (GPT) REAGENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.