FDA 510(k) clearances — page 1295
clearances on record, most recent first.
Clearances — page 1295
129,401–129,500 of 175,890- K890993 — AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID
- K891576 — FEM-FLEX FEMORAL ACCESS CANNULATION SET
- K891786 — PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE)
- K891988 — AMPLAID A308 CLINICAL AUDIOMETER
- K891992 — TENZCARE STIMULATOR 6890
- K893225 — COUPLANT WARMING DEVICE
- K893482 — KORN MANDIBULAR ADVANCER
- K893830 — HEMO-ALERT
- K893990 — P POLYMER
- K894286 — PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER
- K894318 — DATASCOPE INTERLOCK GUIDE WIRE EXTENSION
- K894369 — APDYNE PHENOL APPLICATOR KIT
- K894389 — CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS
- K894462 — CARE DISP. DIAG. ELECTRODES, SILVER/SILVER
- K894476 — CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION
- K894496 — OLYMPUS VALVULOTOME W/FIXED TIP
- K894540 — TELEMETRY RECEIVER ACCESSORY FOR THE CMS 8000
- K894579 — CLEARPLAN EASY
- K894681 — REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER
- K894694 — OMNIFIT CERAMIC MORSE TAPER HEAD
- K894732 — VASCULAR GRAFT PACKAGE (SHELF-LIFE EXTENSION)
- K894747 — PRECEPT-GT(TM) MICROSENSOR PRESSURE MONITOR CATH.
- K894858 — CARE 5000 SYSTEM
- K894933 — PERLIDENT
- K894957 — DISPOSABLE PLASTIC VAGINAL SPECULA
- K894976 — ALTERNATE PACKAGING CONF. OF PACEMAKER LEAD ADAP.
- K894988 — CIBA CORNING MAGIC LITE PROLACTIN IMMUNOASSAY
- K895032 — ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODES
- K895071 — AI5200 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCER
- K895728 — R2 PACE ADAPTOR CABLE, MODEL 196
- K895729 — R2 PACE PAD, MODEL 480
- K885313 — HUMIDI-FLEX TM
- K892450 — MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS
- K892495 — SURGEON'S GLOVES
- K892499 — SAFETY SURGEONS GLOVES
- K892640 — PNEUMOTHORAX KIT, MOTIFICATION
- K894702 — STUART CD UNIVERSAL ROD CONNECTOR CLAMPS
- K894706 — HT-RES RTP SYSTEM
- K895140 — CUSTOM IN-THE-CANAL (ITC) HEARING AID MODEL I54
- K891613 — OVERDENTURE ATTACHMENT
- K893537 — GREENLEAF HAND IMPAIRMENT EVALUATION SYSTEM
- K893597 — HYDRAULIC IV POLE
- K893598 — HYDRAULIC FOOT OPERATED STOOL
- K894189 — SCEPTOR-NEW ANTIMICROBIAL AGENT:TICAR/CLAVU ACID
- K894472 — CROSS ROUND & SQUARE SPINAL RODS & DIST. SPINAL
- K894502 — AMMEL PATIENT EXAMINATION GLOVES
- K894580 — GORE-TEX SURGICAL TAPE
- K894591 — GYNEGUIDE
- K894708 — PT DISTAL TIP CEMENT SPACER
- K894943 — CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3
- K894977 — OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM
- K895073 — POW-IR TIP
- K895101 — BIOTRACK HEMOGLOBIN TEST CARTRIDGE
- K895102 — BIOTRACK PDS MONITOR
- K895127 — ARGOS
- K895448 — RUBBER LATEX SURGICAL GLOVES, STERILE
- K895481 — SHAMROCK SAFETY WINGED INFUSION SET
- K895705 — SHAMROCK SAFETY BLOOD COLLECTION SET
- K892228 — INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM
- K892885 — RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR
- K892903 — MITEK ANCHOR DRILL
- K893205 — FIRST CHOICE (TM)
- K893964 — SPECTRASTIM TM 1000
- K894244 — DEVILBISS MODEL 8500D AND 8500D-608
- K894247 — PERIODONTAL IRRIGATING SOLUTION-D
- K894309 — OHMEDA MODULUS CD ANESTHESIA SYSTEM
- K894334 — SECOND GENERATION KNEE SYSTEM
- K894365 — SINGLE PATIENT USE DISPOSABLE MANUAL RESUSCITATOR
- K894827 — AUTOMIX 3+3 COMPOUNDER
- K894907 — MARK IV HAND, THUMB AND WRIST (CPM) UNIT
- K895105 — HIGH PRESSURE INERT PLASTIC COLUMNS FOR CLIN. USE
- K895128 — BIOTRACK ALT TEST CARTRIDGE
- K895160 — ORTHO *APO A-1 ELISA TEST SYSTEM
- K895178 — TECHNOMED PULSOLITH LASER SYSTEM
- K895181 — ABL500 BLOOD GAS SYSTEM
- K895255 — APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT
- K895260 — ABNORMAL COAGULATION CONTROL PLASMA-1 (ACCP-1)
- K895261 — ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2)
- K895262 — NORMAL COAGULATION CONTROL PLASMA (NCCP)
- K895367 — INTRAVENOUS EXTENSION SET
- K895373 — HEMATOLOGY CONTROL
- K895404 — UNDER BUTTOCKS DRAPE
- K895503 — ABNORMAL REFERENCE PLASMA-VIII
- K895504 — ABNORMAL REFERENCE PLASMA-IX
- K895527 — THE NEEDLE COUNT AND SHARPS DISPOSAL SYSTEM
- K895551 — ROCKET BONE MARROW NEEDLE
- K895594 — SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE
- K895603 — S.S.T. SURGICAL THIMBLE
- K891315 — ATTENUATING SURGICAL GLOVE
- K891449 — SONOLINE CF
- K892639 — THE ORIGINAL PULSE-PAK
- K892841 — BEDFONT EC50 SMOKERLYZER CARBON MONOXIDE MONITOR
- K892888 — EXTACISER PERINEAL MUSCLE EXERCISER
- K894321 — MODEL 285 INFUSION PUMP
- K894361 — LIFECARE PRESSURE ALARM CAT. NO. 34-010
- K894453 — LATEX PATIENT EXAMINATION GLOVES
- K894489 — GYNECOLOGIC EXAMINATION KIT
- K894490 — STERILE ULTRASOUND TRANSMISSION GEL
- K894806 — SIEMENS ENDO-P-PROBE
- K894841 — IRIS OCULIGHT(TM) SL
Data sourced from openFDA. This site is unofficial and independent of the FDA.