FDA 510(k) clearances — page 1324
clearances on record, most recent first.
Clearances — page 1324
132,301–132,400 of 176,637- K893013 — LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE
- K881383 — ND1100 BONE DENSITY SCANNER
- K890592 — PATIENT EXAMINATION GLOVE
- K890618 — COOMASSIE BLUE TOTAL PROTEIN ASSAY KIT
- K890939 — DUPONT DISTAL HUMERAL NAIL
- K890958 — OXITRON OXYGEN ANALYZER
- K891015 — COAG-1 APTT TEST CARD
- K891177 — PATIENT EXAMINATION GLOVES (LATEX)
- K891462 — ROCHE(R) CARDIOSCREEN-CK
- K891468 — AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT
- K891480 — YSI MODEL 2300 STAT GLUCOSE AND L-LACTATE ANALYZER
- K891578 — AVL MODEL 987 ELECTROLYTE ANALYZER
- K891638 — PATIENT EXAMINATION GLOVES (LATEX)
- K891640 — PATIENT EXAMINATION GLOVES (LATEX)(POWDERED)
- K891968 — ESP RADIATION REDUCTION EXAMINATION GLOVES
- K892093 — PATIENT EXAMINATION GLOVES (LATEX)
- K892103 — PATIENT EXAMINATION GLOVES (LATEX)
- K892656 — DRI-DYE CHECK STRIPS (TM)-405
- K892747 — NON-STERILE PATIENT EXAMINATION GLOVES (LATEX)
- K892814 — ARGEDENT 45
- K892819 — AUTOTRANSFUSION DEVICE
- K892853 — T4 CLASP-BEAD EIA KIT
- K892900 — ACA VANCOMYCIN (VANC) METHOD
- K892909 — ARGELITE 80SF+ DENTAL ALLOY
- K892938 — AMNIO-GROW TM
- K892943 — MULTI PULSE POWER UNIT GENERATOR
- K884405 — FORTEC MI-150 DIGITAL BLOOD PRESSURE METER
- K884804 — THE COACH
- K890206 — E-Z-FLOW ANGIOGRAPHY CATHETERS
- K890208 — HIGH PRESSURE CONNECTING SETS
- K890209 — DISPOSABLE ANGIOGRAPHY NEEDLES
- K890445 — PERSONAL ALERT ASSIST DEVICE
- K890525 — INTERTON BTE HEAR AID, SUPRA, SUPREMA, MINETTA
- K890938 — KENDALL SCD THERAPEUTIC SYSTEM
- K891000 — MODIFIED EXTERNAL PAD
- K891022 — INTRODUCER FOR PTCA GUIDING CATHETERS
- K891230 — MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV.
- K891320 — ARGELITE 58P (DENTAL ALLOY)
- K891463 — ADHERENCE M5 MULTI-CURE COMPOSITE CEMENT SYSTEM
- K892211 — HERAEUS LASERSONIC INC. STERILE DISPOSABLE FIBERS
- K892333 — REXTON RX12PP, RX20PP & RX34PP IN-THE-EAR HEAR AID
- K892336 — BEHIND-THE-EAR HEARING AID MODEL 48 PP PC
- K892431 — KENDALL CURITY FEEDING TUBES
- K892708 — ARGEDENT Y-86 DENTAL ALLOY
- K892812 — ARGELITE 75+6
- K892813 — ARGELITE 60
- K892815 — ARGEDENT 45SF
- K892816 — ARGEDENT 38
- K892908 — ARGELITE 80SF DENTAL ALLOY
- K893008 — ARGELITE 54
- K893009 — ARGELITE SR+
- K893011 — ARGIPAL
- K884396 — MODIFIED THER-A-PULSE UNIT
- K884732 — SUPERIOR ENDOSSEOUS DENTAL IMPLANT SYSTEM
- K884739 — SGARLATO LESSER TOE IMPLANT
- K890274 — MEM-7102; MEB-7102 EVOKED RESPONSE & ELECTRO RECOR
- K891176 — INJECTION SITE PLUG (INTRAVASCULAR ADMINISTRATION)
- K891455 — DENTIN PRIMER
- K891464 — RESILIENCE C2, RESILIENCE L3 & RESILIENCE P4
- K891924 — SCOPIX LASER IMAGER
- K891931 — QCT-LUNG NODULE (TM) ANALYSIS PACKAGE
- K892113 — Q5000 PC WORKSTATION
- K892221 — PULMONARY RESUSCITATOR, MODIFICATION
- K892234 — ARGEDENT 75
- K892239 — DENTAL HAND INSTRUMENTS
- K892374 — NEW AM-SERIES DIALYZERS
- K892375 — MODIFIED AM-SERIES DIALYZERS
- K892549 — SUCTION TUBES: HOUSE, BARON
- K892870 — PERITONEAL DIALYSIS CYCLER SET, W/5 PRONG MANIFOLD
- K892871 — PERITONEAL DIALYSIS CYCLER SET, W/8 PRONG MANIFOLD
- K892872 — PERITONEAL DIALYSIS CYCLER SET W/12 PRONG MANIFOLD
- K885230 — MCDONALD FOLDING FORCEPS
- K890714 — LACRIMAL EFFICIENCY TEST (TM)
- K890992 — WOODLYN OPHTHALMIC PROJECTOR
- K892241 — FETAL HEMOGLOBIN
- K892897 — NOVA GEL(TM) JO-1
- K892911 — SITE PERISTALTIC CASSETTE
- K883840 — DRI-VENT ARTERIAL BLOOD SAMPLING KIT
- K884151 — MODEL G7731D WASHER/DISINFECTOR FOR DENTAL INSTRU.
- K884266 — PH BLOOD GAS CONTROL PRODUCTS
- K885231 — KITCHIN DENTAL ABCESS DRAIN
- K890055 — ACUSON S228 TRANSDUCER FOR TRANSCRANIAL DOPPLER
- K890407 — THE SAXON SPERMICIDAL CONDOM W/2 YEAR EXPIRATION
- K890588 — GENTLE EXPRESSIONS ELECTRIC BREAST PUMP
- K890783 — GRIESHABER VISCOELASTIC INJECTION SYSTEM
- K890919 — TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT
- K890969 — TRANSESOPHAGEAL TRANSDUCER PEF-511SA
- K891009 — INTRAVASCULAR ADMINISTRATION SET MODEL 60040
- K891309 — 5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER
- K891386 — CVIS ULTRA-SCAN ONE IMAGING SYSTEM
- K891482 — AML(R) COLLARLESS LATERALIZED FEMORAL HIP
- K891761 — GDS ENZYMATIC THEOPHYLLINE REAGENT
- K892650 — TDX BARBITURATES SERUM
- K892901 — ACA VANCOMYCIN CALIBRATOR
- K884628 — HARBORIN CENTRAL VENOUS CATHETER
- K885348 — A-V(TM) SOFTOUCH UHF CARDIAC PIGTAIL
- K890642 — VZV MICROASSAY
- K890922 — ACCU-BEAM YAG FIBER
- K890962 — ORTHOPAEDIC STAPLES
- K891903 — COHN TARGETEER
Data sourced from openFDA. This site is unofficial and independent of the FDA.