FDA 510(k) clearances — page 1284
clearances on record, most recent first.
Clearances — page 1284
128,301–128,400 of 176,637- K895345 — ORAD TOOTHBRUSH CLEANER
- K895988 — POTASSIUM NITRATE-ZINC OXIDE EUGENOL TEMP. DENTAL
- K896061 — ERECTION DEVICE
- K896278 — SCEPTOR - NEW ANTIMICROBIAL AGENT - CEFOTETAN
- K896448 — BALLOON DILATION CATHETER
- K896876 — DYNATORQ DENTAL HANDPIECE ATTACHMENTS
- K896877 — DENTAL AIR MOTORS (SEVERAL MODELS)
- K896879 — ORAL SURGERY HANDPIECE AND ATTACHMENTS
- K896952 — THERMOSCAN-INSTANT THERMOMETER MODEL IR-2000
- K900035 — WILSON-COOK COLON DECOMPRESSION SET
- K900413 — INTELECT 775MP POWERED MUSCLE STIMULATOR
- K884235 — COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KIT
- K890895 — IMPLANTABLE ADAPTOR 033-380
- K892912 — MODEL JM-1 CO2 LASER
- K894563 — OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM814F
- K895356 — UNIVOX-IC
- K895645 — BIOSOUND PHASE 2 DIAGNOSTIC ULTRASOUND SYSTEM
- K895719 — TELEREHAB SYSTEM FOR CARDIAC REHABILITATION
- K896194 — CAPTIA(R) CMV-G
- K896295 — CAPTIA(R) CMV-M
- K896313 — MEDTRONIC IMPLANTABLE PACING LEADS W/IS-1 CONN.
- K896403 — MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM
- K896482 — PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT
- K896843 — EXPLORER 24 DENTAL HAND INSTRUMENT
- K896920 — SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER
- K896937 — HYCOR ACCUPINCH COCAINE TEST
- K896941 — AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS
- K896959 — RADIO-TEMP THERMOMETER
- K896986 — BLOOD PRESSURE CUFF
- K897036 — IMMUNOTECH CHOLESTEROL TEST
- K897080 — CARDIOCAP(TM) CT-104 MONITOR
- K897082 — SCHNEIDER SIDEKICK MONORAIL Y-CONNECTOR
- K900031 — MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS
- K900077 — SHARPLAN 1041 SEALED-OFF CO2 SURGICAL LASER SYSTEM
- K900377 — COLLEGE OF AMER PATH. REFER. PREP. FOR FIBRINOGEN
- K900406 — FACTOR V DEFICIENT PLASMA
- K900407 — FACTOR VII DEFICIENT PLASMA
- K900408 — FACTOR VIII DEFICIENT PLASMA
- K900409 — FACTOR IX DEFICIENT PLASMA
- K900410 — FACTOR X DEFICIENT PLASMA
- K900411 — FACTOR XI DEFICIENT PLASMA
- K900412 — FACTOR XII DEFICIENT PLASMA
- K900462 — OSTEONICS CEMENT RESTRICTOR
- K900605 — 3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100
- K900626 — ALPHA URINE SAMPLE
- K900655 — MODIFIED CAPTIA(R) TOXO-M
- K900875 — RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT
- K900906 — FACTOR II DEFICIENT PLASMA
- K893006 — EXMOOR BITE BUFFER
- K894259 — REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA
- K895114 — FRANK MILK PUMP
- K895225 — GYNECOLOGICAL INSTRUMENTATION
- K895368 — IN THE EAR HEARING AID
- K895449 — ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM
- K896909 — MD5 AUTOMATIC AUDIOMETER
- K896917 — HYSTEROSCOPE
- K896928 — FILPOST
- K893852 — COULTER CLONE T4 MONOCLONAL ANTIBODY
- K893853 — COULTER CLONE T8 MONOCLONAL ANTIBODY
- K896081 — WHITESIDE ORTHOLOC MODULAR METAL-BACKED PATELLA
- K896826 — SULTAN PERIO-SELECT IRRIGATION SYSTEM
- K896914 — IVAC MODEL 2090 INFRA RED THERMOMETER
- K897134 — CMW CEMENT PRESSURISATION SYSTEM
- K900005 — DEXTROLYTE II, MANUAL ADMINISTRATION SET 48-1032-1
- K900124 — APOLIPOPROTEIN B (APO B)
- K900674 — CONSTI-SSAGE VIBRATOR/MASSAGE
- K900794 — MOBILIMB H3 HAND CPM UNIT
- K896465 — CLP CK/LD ISOENZYME/IMMUNO CONTROL
- K896583 — F.A.S.T. TABLE
- K896794 — SPECIMEN CONTAINER
- K896924 — SPIROSCAN 4000
- K896991 — ENZYMUN TEST(R) TBK
- K897128 — UMI BRAIDED CATHETER CONNECTOR
- K897158 — ABBOTT COMMANDER PARALLEL PROCESSING CENTER
- K897161 — COULTER URIC ACID REAGENT
- K900147 — MODIFIED DSL-2300 ACTH RIA
- K900224 — STAT FAX(TM)-2100
- K900250 — AMRESCO ALKALINE PHOSPHATASE REAGENTS 7780 & 7781
- K900266 — STERILE CARBON STEEL SURGICAL BLADE
- K900300 — LYTENING 2Z LYTENING SYSTEM 31
- K900310 — REPEL SURGICAL GLOVE LINERS
- K900392 — CENTERING PLUG
- K900405 — SCHOLTEN FRAME
- K900420 — BICARBONATE REAGENTS PRODUCT #7713 & #7714
- K900621 — FIAGEN(TM) HLH.S
- K900656 — SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT.
- K885046 — INSITUCAT VALVE STRIPPER
- K890182 — PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV
- K893221 — MODEL 8500 HAND HELD PULSE OXIMETER
- K893711 — DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR
- K894826 — UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF
- K895179 — ACCESSOR PERIPHERAL DILATING GUIDE WIRE
- K895511 — CATHETER BALLOON DILATOR PRESSURE GAUGE
- K895776 — AIV SYSTEMS' IV POLES
- K896039 — KING OF HEARTS 1200 MONITOR
- K896735 — TYPE 9290 INTERFACE RESPIRATOR
- K896736 — TYPE 9291 INTERFACE RESPIRATOR
- K896737 — TYPE 9292 INTERFACE CAPNOGRAPH
- K896741 — SCHNEIDER MONORAIL-PMC PRESSURE MONITORING CATH.
- K896849 — ACS INDEFLATOR XX
Data sourced from openFDA. This site is unofficial and independent of the FDA.