FDA 510(k) clearances — page 1313
clearances on record, most recent first.
Clearances — page 1313
131,201–131,300 of 176,637- K892925 — VECSEI EXPANDING SCREW
- K893219 — MATRX DENTAL UNIT
- K893820 — CT SYTEC 3000
- K893866 — HOOD PEDIATRIC TRACHEOSTOMY TUBE
- K893938 — CONTINUOUS EPIDURAL ANESTHESIA TRAY
- K893949 — #157 EXAM LIGHT
- K894014 — LATEX EXAMINATION GLOVES
- K894072 — THE PUDENZ IN LINE VALVE
- K894273 — NIDEK MODEL AKC-8000
- K894302 — OXYGEN THERAPY REGULATOR
- K894396 — SURGILASE 25, 40, 45, 55, 60, 80, 100 LASER
- K894557 — LIGHTSCOPE SET
- K894558 — MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET
- K884261 — PROWESS 2000
- K892068 — TRT (ACUSON) NEEDLE GUIDE KIT, STERILE
- K892193 — QUICKPAD (ALCOHOL SWABS)
- K892772 — NON-STERILE PATIENT EXAMINATION GLOVES
- K893043 — PURITAN-BENNETT 7200SPI MICROPROCESSOR VENTILATOR
- K893213 — EASY BREATHER MODEL 100
- K893432 — PERSONAL AMPLIFIER RECHARGEABLE MODEL TRIUMPH II
- K893508 — PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI
- K893725 — PLAYTEX TAMPONS, NON-DEODORANT/DEODORANT
- K893927 — RESOUND CUSTOM IN-THE CANAL HEARING AID PHS-3
- K894031 — PHARMASEAL GENETIC AMNIOCENTESIS TRAY
- K894336 — SURGICAL DYNAMICS DISCOGRAPHY SYSTEM
- K894538 — QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK
- K884183 — BURRON TEFLON-COATED GUIDEWIRE
- K890195 — JAMES SURGICAL SYSTEM J1000
- K890402 — MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE)
- K890862 — AMBULATORY INFUSION PUMP
- K891184 — PATIENT EXAMINATION GLOVES (LATEX)
- K891276 — QBC MALARIA SYSTEM
- K891371 — GILSDORF PERCU. ENDO.-PEG & PERCU. FLOURO.-PFG
- K891580 — INTRAVASCULAR CATHETER WITH HYDROPHILIC COATING
- K891585 — HYDRO-SAN COLONIC IRRIGATION SYSTEM
- K891783 — RUBELLA ELISA TEST SYSTEM
- K892338 — BEHIND-THE-EAR HEARING AID MODEL 48 AGCI
- K892714 — IFA SENSIBAC NEOMYCIN
- K892715 — IFA SENSIBAC NITROFURANTOIN
- K892717 — IFA SENSIBAC BACITRACIN
- K892718 — IFA SENSIBAC TETRACYCLINE
- K892719 — IFA SENSIBAC ERYTHROMYCIN
- K892722 — IFA SENSIBAC CINOXACIN
- K892723 — IFA SENSIBAC POLYMYXIN B
- K892724 — IFA SENSIBAC STREPTOMYCIN
- K892725 — IFA SENSIBAC VANCOMYCIN
- K892727 — IFA SENSIBAC INIPENEM
- K892729 — IFA SENSIBAC TOBRAMYCIN
- K892730 — IFA SENSIBAC CHLROAMPHENICOL
- K892800 — MG II POROUS TOTAL KNEE SYSTEM
- K892940 — PRECIOUS LITE MODEL 4224
- K892971 — LATEX EXAM GLOVES
- K892981 — PATIENT EXAMINATION GLOVES
- K892982 — PATIENT LATEX EXAMINATION GLOVES
- K893134 — APACERAM OSSICULAR PROSTHESIS
- K893264 — LATEX EXAMINATION GLOVES
- K893403 — MODELS HP 43110MC, 43200MC W/CASE & 43200M NO CASE
- K893404 — INTEGRA(TM) BLOOD GLUCOSE MONITORING SYSTEM
- K893419 — COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM)
- K893470 — SIEMENS SAO2 + PULS OXIMETRY CARTRIDGE
- K893547 — CLINIMATE-TDA BLOOD CHEMISTRY ANALYZER
- K893548 — SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP
- K893577 — STATUS HCG FLUOROMETRIC ENZYME
- K893639 — GAMMA LOCKING NAIL
- K893658 — PERCUTANEOUS INTRODUCER
- K893683 — SARNS PRESSURE ADJUSTABLE SAFETY SYSTEM
- K893715 — ETHICON DISPOSABLE SURGICAL TROCAR
- K893776 — ABBOTT ASSET AUTOMATED CLINICAL CHEMISTRY ANALYZER
- K893810 — IMMUNO-WASH AUTOMATED TUBE WASHER
- K893854 — COBAS FARA II CENTRIFUGAL ANALYZER
- K893855 — ABUSCREEN ONTRAK POS. REF. CONTROL FOR BARBITUATES
- K893856 — ABUSCREEN ONTRAK POS. REF. CONTROL FOR MORPHINE
- K893857 — ABUSCREEN ONTRAK POS. REF. CONTROL FOR AMPHETAMINE
- K893858 — ABUSCREEN ONTRAK POS. REFERENCE CONTROL FOR THC
- K893859 — ABUSCREEN ONTRAK POS. REF. CONTROL FOR COCAINE
- K893860 — ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE
- K893869 — GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE)
- K893871 — GOOTT BALFOUR BLADE
- K893900 — PRIMAPORE I.V.
- K893905 — PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1)
- K893950 — VENTIPRESS 24 AND 14 PRESSURE VENTILATOR
- K893961 — ABBOTT IMX(TM) D-DIMER
- K894091 — AMERLEX-MAB FT4 KIT
- K894110 — QUALICHECK 2
- K894159 — OPUS IMMUNOASSAY SYSTEM
- K894161 — ASC-950 ECG AMPLIFIER
- K894234 — SENSOCOR TM R-TEST 24OXL
- K894249 — UNIVERSAL CEMENTED CUP
- K894301 — MICRO-AIRE STERNUM SAW 4800
- K894327 — EMIT D.A.U. LOW & MEDIUM CALIBRATOR A
- K894346 — D88VS WHEELCHAIR POWER SYSTEM
- K894422 — TUFFCARE MEDICAL PRODUCTS WHEELCHAIR
- K894425 — ACS HUMAN PLASMA COAGULATION CONTROL LEVEL III
- K894435 — VAX-T PELVIC TRACTION BELT
- K891013 — MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING
- K891076 — CAPNOMAC II(TM) ANESTHESIA MULTIGAS MONITOR
- K891405 — BMS-2000 MOBILE EEG SYSTEM
- K892520 — BREATHING CIRCUIT BACTERIAL FILTERS
- K893630 — CANDELA UPC LASER PHOTOCOAGULATOR
- K893640 — SOFTWARE VERSION, D1.3 AND A1.3 FOR MAGNETOM
Data sourced from openFDA. This site is unofficial and independent of the FDA.